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"Lung Diseases - prevention "
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High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial
by
Pelosi, Paolo
,
Schultz, Marcus J
,
Hemmes, Sabrine N T
in
Abdomen - surgery
,
Abdominal surgery
,
Aged
2014
The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension. We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery.
In this randomised controlled trial at 30 centres in Europe and North and South America, we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg. We randomly allocated patients to either a high level of positive end-expiratory pressure (12 cm H2O) with recruitment manoeuvres (higher PEEP group) or a low level of pressure (≤2 cm H2O) without recruitment manoeuvres (lower PEEP group). We used a centralised computer-generated randomisation system. Patients and outcome assessors were masked to the intervention. Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5. Analysis was by intention-to-treat. The study is registered at Controlled-Trials.com, number ISRCTN70332574.
From February, 2011, to January, 2013, 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group. Six patients were excluded from the analysis, four because they withdrew consent and two for violation of inclusion criteria. Median levels of positive end-expiratory pressure were 12 cm H2O (IQR 12–12) in the higher PEEP group and 2 cm H2O (0–2) in the lower PEEP group. Postoperative pulmonary complications were reported in 174 (40%) of 445 patients in the higher PEEP group versus 172 (39%) of 449 patients in the lower PEEP group (relative risk 1·01; 95% CI 0·86–1·20; p=0·86). Compared with patients in the lower PEEP group, those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs.
A strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications. An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure, without recruitment manoeuvres.
Academic Medical Center (Amsterdam, Netherlands), European Society of Anaesthesiology.
Journal Article
An anesthesia-centered bundle to reduce postoperative pulmonary complications: The PRIME-AIR study protocol
2023
Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality after open abdominal surgery. Optimized perioperative lung expansion may minimize the synergistic factors responsible for the multiple-hit perioperative pulmonary dysfunction. This ongoing study will assess whether an anesthesia-centered bundle focused on perioperative lung expansion results in decreased incidence and severity of PPCs after open abdominal surgery.
Prospective multicenter randomized controlled pragmatic trial in 750 adult patients with at least moderate risk for PPCs undergoing prolonged (≥2 hour) open abdominal surgery. Participants are randomized to receive either a bundle intervention focused on perioperative lung expansion or usual care. The bundle intervention includes preoperative patient education, intraoperative protective ventilation with individualized positive end-expiratory pressure to maximize respiratory system compliance, optimized neuromuscular blockade and reversal management, and postoperative incentive spirometry and early mobilization. Primary outcome is the distribution of the highest PPC severity by postoperative day 7. Secondary outcomes include the proportion of participants with: PPC grades 1-2 through POD 7; PPC grades 3-4 through POD 7, 30 and 90; intraoperative hypoxemia, rescue recruitment maneuvers, or cardiovascular events; and any major extrapulmonary postoperative complications. Additional secondary and exploratory outcomes include individual PPCs by POD 7, length of postoperative oxygen therapy or other respiratory support, hospital resource use parameters, Patient-Reported Outcomes Measurements (PROMIS®) questionnaires for dyspnea and fatigue collected before and at days 7, 30 and 90 after surgery, and plasma concentrations of lung injury biomarkers (IL6, IL-8, RAGE, CC16, Ang-2) analyzed from samples obtained before, end of, and 24 hours after surgery.
Participant recruitment for this study started January 2020; results are expected in 2024. At the conclusion of this trial, we will determine if this anesthesia-centered strategy focused on perioperative lung expansion reduces lung morbidity and healthcare utilization after open abdominal surgery.
ClinicalTrial.gov NCT04108130.
Journal Article
Effects of a liquefied petroleum gas stove intervention on pollutant exposure and adult cardiopulmonary outcomes (CHAP): study protocol for a randomized controlled trial
by
Harvey, Steven A.
,
Kephart, Josiah L.
,
Nangia, Saachi
in
Adult
,
Air pollution
,
Air Pollution, Indoor - adverse effects
2017
Background
Biomass fuel smoke is a leading risk factor for the burden of disease worldwide. International campaigns are promoting the widespread adoption of liquefied petroleum gas (LPG) in resource-limited settings. However, it is unclear if the introduction and use of LPG stoves, in settings where biomass fuels are used daily, reduces pollution concentration exposure, improves health outcomes, or how cultural and social barriers influence the exclusive adoption of LPG stoves.
Methods
We will conduct a randomized controlled, field intervention trial of LPG stoves and fuel distribution in rural Puno, Peru, in which we will enroll 180 female participants aged 25–64 years and follow them for 2 years. After enrollment, we will collect information on sociodemographic characteristics, household characteristics, and cooking practices. During the first year of the study, LPG stoves and fuel tanks will be delivered to the homes of 90 intervention participants. During the second year, participants in the intervention arm will keep their LPG stoves, but the gas supply will stop. Control participants will receive LPG stoves and vouchers to obtain free fuel from distributors at the beginning of the second year, but gas will not be delivered. Starting at baseline, we will collect longitudinal measurements of respiratory symptoms, pulmonary function, blood pressure, endothelial function, carotid artery intima-media thickness, 24-h dietary recalls, exhaled carbon monoxide, quality-of-life indicators, and stove-use behaviors. Environmental exposure assessments will occur six times over the 2-year follow-up period, consisting of 48-h personal exposure and kitchen concentration measurements of fine particulate matter and carbon monoxide, and 48-h kitchen concentrations of nitrogen dioxide for a subset of 100 participants.
Discussion
Findings from this study will allow us to better understand behavioral patterns, environmental exposures, and cardiovascular and pulmonary outcomes resulting from the adoption of LPG stoves. If this trial indicates that LPG stoves are a feasible and effective way to reduce household air pollution and improve health, it will provide important information to support widespread adoption of LPG fuel as a strategy to reduce the global burden of disease.
Trial registration
ClinicalTrials.gov, ID:
NCT02994680
, Cardiopulmonary Outcomes and Household Air Pollution (CHAP) Trial. Registered on 28 November 2016.
Journal Article
Effect of perioperative sigh ventilation on postoperative hypoxemia and pulmonary complications after on-pump cardiac surgery (E-SIGHT): study protocol for a randomized controlled trial
2024
Background
Postoperative hypoxemia and pulmonary complications remain a frequent event after on-pump cardiac surgery and mostly characterized by pulmonary atelectasis. Surfactant dysfunction or hyposecretion happens prior to atelectasis formation, and sigh represents the strongest stimulus for surfactant secretion. The role of sigh breaths added to conventional lung protective ventilation in reducing postoperative hypoxemia and pulmonary complications among cardiac surgery is unknown.
Methods
The perioperative sigh ventilation in cardiac surgery (E-SIGHT) trial is a single-center, two-arm, randomized controlled trial. In total, 192 patients scheduled for elective cardiac surgery with cardiopulmonary bypass (CPB) and aortic cross-clamp will be randomized into one of the two treatment arms. In the experimental group, besides conventional lung protective ventilation, sigh volumes producing plateau pressures of 35 cmH
2
O (or 40 cmH
2
O for patients with body mass index > 35 kg/m
2
) delivered once every 6 min from intubation to extubation. In the control group, conventional lung protective ventilation without preplanned recruitment maneuvers is used. Lung protective ventilation (LPV) consists of low tidal volumes (6–8 mL/kg of predicted body weight) and positive end-expiratory pressure (PEEP) setting according to low PEEP/FiO
2
table for acute respiratory distress syndrome (ARDS). The primary endpoint is time-weighted average SpO
2
/FiO
2
ratio during the initial post-extubation hour. Main secondary endpoint is the severity of postoperative pulmonary complications (PPCs) computed by postoperative day 7.
Discussion
The E-SIGHT trial will be the first randomized controlled trial to evaluate the impact of perioperative sigh ventilation on the postoperative outcomes after on-pump cardiac surgery. The trial will introduce and assess a novel perioperative ventilation approach to mitigate the risk of postoperative hypoxemia and PPCs in patients undergoing cardiac surgery. Also provide the basis for a future larger trial aiming at verifying the impact of sigh ventilation on postoperative pulmonary complications.
Trial registration
ClinicalTrials.gov NCT06248320. Registered on January 30, 2024. Last updated February 26, 2024.
Journal Article
Effects of ultrasound-guided recruitment manoeuvres on postoperative pulmonary complications in laparoscopic bariatric surgery patients: study protocol for a randomised clinical trial
2025
Background
Lung ultrasound-guided alveolar recruitment manoeuvres (RMs) may reduce the lung ultrasound score. However, whether the use of this strategy can reduce the incidence of postoperative pulmonary complications (PPCs) in the adult obese population has not yet been tested.
Methods/design
This is a single-centre, two-arm, prospective, randomised controlled trial. A total number of 476 obese patients scheduled for bariatric surgeries will be enrolled. They will be randomly assigned to receive either lung ultrasound-guided RMs (intervention group) or conventional RMs (control group) intraoperatively. The occurrence of PPCs will be recorded as the primary outcome.
Discussion
To the best of our knowledge, this is the first trial to test the effect of lung ultrasound-guided RMs on PPCs. The results of this trial will support the anaesthesiologists in choosing a potentially more efficient method to perform RMs for bariatric surgery patients.
Trial registration
www.chictr.org.cn
ChiCTR2400080203. Registered on 23 January 2024.
Journal Article
Preoperative chlorhexidine mouthwash can reduce the risk of postoperative pulmonary complications in elderly patients undergoing general anesthesia with endotracheal intubation
2025
To investigate whether preoperative chlorhexidine mouthwash can reduce the risk of postoperative pulmonary complications(PPCs) in elderly patients with tracheal intubation under general anesthesia. 78 elderly patients undergoing elective surgery under general anesthesia and endotracheal intubation were randomly divided into the chlorhexidine group (CH group,
n
= 39) and the normal saline group (NS group,
n
= 39). Nurses instructed patients to gargle with 15 ml saline or compound chlorhexidine mouthwash the night before surgery, on the morning of surgery, and upon entering the operating room. The primary outcome was lung ultrasound score (LUS) on postoperative day 1 (D
1
). The secondary outcome was LUS on the preoperative day (D
0
) and postoperative day 3 (D
3
), bacterial colony count at the tip of the endotracheal tube, inflammatory markers (IL-1β, IL-6, TNF-α), and the incidence of postoperative fever, pneumonia, cough severity and sputum production. The CH group had significantly lower D
1
LUS compared to the NS group, whereas there was no significant difference in D
3
LUS between the groups. Within three postoperative days, there were no significant differences between the groups in cough severity, sputum production, fever, inflammatory markers, or pneumonia incidence. Bacterial colony counts on the endotracheal tube at extubation were lower in the CH group than in the NS group. Post hoc sensitivity analysis revealed that in patients with oral frailty, the number of colonies cultured at D
1
LUS, D
3
LUS, and the catheter tip in the CH group was lower than that in the NS group. However, there was no significant difference between the two groups in terms of the incidence of pneumonia and other aspects. Exploratory subgroup analysis showed that chlorhexidine mouthwash significantly reduced postoperative LUS in patients with oral frailty, while there were no significant differences in gender, smoking and age subgroups. Preoperative chlorhexidine mouthwash improved early postoperative LUS in elderly patients by reducing oropharyngeal bacterial colonization, particularly in those with oral weakness, though clinical outcomes like pneumonia showed no significant differences. Chinese clinical trial registration number: ChiCTR2400089898.
Journal Article
Effect of the alveolar recruitment maneuver during laparoscopic colorectal surgery on postoperative pulmonary complications: A randomized controlled trial
2024
Intraoperative lung-protective ventilation, including low tidal volume and positive end-expiratory pressure, reduces postoperative pulmonary complications. However, the effect and specific alveolar recruitment maneuver method are controversial. We investigated whether the intraoperative intermittent recruitment maneuver further reduced postoperative pulmonary complications while using a lung-protective ventilation strategy. Adult patients undergoing elective laparoscopic colorectal surgery were randomly allocated to the recruitment or control groups. Intraoperative ventilation was adjusted to maintain a tidal volume of 6–8 mL kg −1 and positive end-expiratory pressure of 5 cmH 2 O in both groups. The alveolar recruitment maneuver was applied at three time points (at the start and end of the pneumoperitoneum, and immediately before extubation) by maintaining a continuous pressure of 30 cmH 2 O for 30 s in the recruitment group. Clinical and radiological evidence of postoperative pulmonary complications was investigated within 7 days postoperatively. A total of 125 patients were included in the analysis. The overall incidence of postoperative pulmonary complications was not significantly different between the recruitment and control groups (28.1% vs. 31.1%, P = 0.711), while the mean ± standard deviation intraoperative peak inspiratory pressure was significantly lower in the recruitment group (10.7 ± 3.2 vs. 13.5 ± 3.0 cmH 2 O at the time of CO 2 gas-out, P < 0.001; 9.8 ± 2.3 vs. 12.5 ± 3.0 cmH 2 O at the time of recovery, P < 0.001). The alveolar recruitment maneuver with a pressure of 30 cmH 2 O for 30 s did not further reduce postoperative pulmonary complications when a low tidal volume and 5 cmH 2 O positive end-expiratory pressure were applied to patients undergoing laparoscopic colorectal surgery and was not associated with any significant adverse events. However, the alveolar recruitment maneuver significantly reduced intraoperative peak inspiratory pressure. Further study is needed to validate the beneficial effect of the alveolar recruitment maneuver in patients at increased risk of postoperative pulmonary complications. Trial registration: Clinicaltrials.gov ( NCT03681236 ).
Journal Article
Impact of early high flow nasal oxygen on diaphragmatic function and pulmonary complications after thoracic surgery: A randomized clinical trial
2025
Postoperative pulmonary complications (PPCs) are common after thoracic surgery, particularly in patients that develop postoperative diaphragmatic dysfunction. High-flow nasal cannula (HFNC) oxygen therapy decreases postoperative work of breathing and provides a positive end-expiratory pressure (PEEP) effect. As a result, it may decrease the occurrence of diaphragmatic dysfunction and PPCs after thoracic surgery.
Single-centre, open-label, randomized controlled trial. Patients undergoing video-assisted thoracoscopic lobectomy were randomized to receive conventional oxygen therapy (COT) or high flow nasal cannula oxygen therapy. In both groups, inspiratory oxygen fraction was titrated to reach a peripheral oxygen saturation of >94 %. Diaphragmatic displacement (DD) and diaphragmatic thickening fraction (TF%) were measured 2 and 24 h after surgery. Diaphragmatic dysfunction was identified by DD <10 mm. PPCs occurring within 7 days after study enrollment were recorded.
We analyzed 116 patients in the study. Postoperative diaphragmatic dysfunction occurred in 17/58 patients (29 %) in the HFNC group compared to 21/58 (36 %) in the COT group (p = 0.55). The rate of PPCs was similar between the two groups: 32/58 (55 %) in the HFNC group and 37/58 (64 %) in the COT group (p = 0.449). Patients who developed postoperative diaphragmatic dysfunction experienced fewer PPCs when treated with HFNC (20/37; 54 %) compared to COT (17/21; 81 %) (p = 0.037). A post hoc mixed-model analysis confirmed that HFNC reduced the risk of PPCs in patients with diaphragmatic dysfunction (OR 0.16, 95 % CI 0.02–0.83).
Early HFNC support does not decrease the rate of postoperative diaphragmatic dysfunction rate or respiratory complications. In patients who develop postoperative diaphragmatic dysfunction, HFNC may play a role in mitigating the risk of PPCs.
Clinical trial registration:NCT05532033
•Postoperative diaphragmatic dysfunction is common after thoracic surgery•Postoperative diaphragmatic dysfunction is a risk factor for PPCs•Early HFNC support does not reduce the incidence of postoperative diaphragmatic dysfunction.•HFNC seems to reduce the incidence of PPCs in patients with postoperative diaphragmatic dysfunction
Journal Article
Prospective evaluation of respiratory exacerbations in children with cystic fibrosis from newborn screening to 5 years of age
by
Carlin, John B
,
Wainwright, Claire E
,
Vidmar, Suzanna
in
Anti-Bacterial Agents - therapeutic use
,
Antibiotic Prophylaxis - methods
,
Antibiotics
2013
Background Newborn screening allows novel treatments for cystic fibrosis (CF) to be trialled in early childhood before irreversible lung injury occurs. As respiratory exacerbations are a potential trial outcome variable, we determined their rate, duration and clinical features in preschool children with CF; and whether they were associated with growth, lung structure and function at age 5 years. Methods Respiratory exacerbations were recorded prospectively in Australasian CF Bronchoalveolar Lavage trial subjects from enrolment after newborn screening to age 5 years, when all participants underwent clinical assessment, chest CT scans and spirometry. Results 168 children (88 boys) experienced 2080 exacerbations, at an average rate of 3.66 exacerbations per person-year; 80.1% were community managed and 19.9% required hospital admission. There was an average increase in exacerbation rate of 9% (95% CI 4% to 14%; p<0.001) per year of age. Exacerbation rate differed by site (p<0.001) and was 26% lower (95% CI 12% to 38%) in children receiving 12 months of prophylactic antibiotics. The rate of exacerbations in the first 2 years was associated with reduced forced expiratory volume in 1 s z scores. Ever having a hospital-managed exacerbation was associated with bronchiectasis (OR 2.67, 95% CI 1.13 to 6.31) in chest CT scans, and lower weight z scores at 5 years of age (coefficient −0.39, 95% CI −0.74 to −0.05). Conclusions Respiratory exacerbations in young children are markers for progressive CF lung disease and are potential trial outcome measures for novel treatments in this age group.
Journal Article
Effect of flow-optimized pressure control ventilation-volume guaranteed (PCV-VG) on postoperative pulmonary complications: a consort study
Background
Postoperative pulmonary complications (PPCs) after one-lung ventilation (OLV) significantly impact patient prognosis and quality of life.
Objective
To study the impact of an optimal inspiratory flow rate on PPCs in thoracic surgery patients.
Methods
One hundred eight elective thoracic surgery patients were randomly assigned to 2 groups in this consort study (control group:
n
= 53 with a fixed inspiratory expiratory ratio of 1:2; and experimental group [flow rate optimization group]:
n
= 55). Measurements of Ppeak, Pplat, PETCO
2
, lung dynamic compliance (Cdyn), respiratory rate, and oxygen concentration were obtained at the following specific time points: immediately after intubation (T0); immediately after starting OLV (T1); 30 min after OLV (T2); and 10 min after 2-lung ventilation (T4). The PaO
2
:FiO
2
ratio was measured using blood gas analysis 30 min after initiating one-lung breathing (T2) and immediately when OLV ended (T3). The lung ultrasound score (LUS) was assessed following anesthesia and resuscitation (T5). The occurrence of atelectasis was documented immediately after the surgery. PPCs occurrences were noted 3 days after surgery.
Results
The treatment group had a significantly lower total prevalence of PPCs compared to the control group (3.64% vs. 16.98%;
P
= 0.022). There were no notable variations in peak airway pressure, airway plateau pressure, dynamic lung compliance, PETCO
2
, respiratory rate, and oxygen concentration between the two groups during intubation (T0). Dynamic lung compliance and the oxygenation index were significantly increased at T1, T2, and T4 (
P
< 0.05), whereas the CRP level and number of inflammatory cells decreased dramatically (
P
< 0.05).
Conclusion
Optimizing inspiratory flow rate and utilizing pressure control ventilation -volume guaranteed (PCV-VG) mode can decrease PPCs and enhance lung dynamic compliance in OLV patients.
Journal Article