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514 result(s) for "Airway protocol"
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Clinical application of intubation-free anesthesia in radical resection of lung cancer
In recent years, video-assisted thoracic surgery (VATS) has become increasingly widespread. However, the implementation of VATS requires the assistance with lung isolation techniques. Spontaneous breathing with laryngeal masks is also increasingly used in VATS. However, evidence on the characteristics of intubated anesthesia is insufficient. This study aimed to explore whether intubation-free anesthesia has more advantages than other intubation methods in the clinical setting. Patients with lung tumors who underwent VATS in our hospital between June 2022 and October 2022 were included in the study. Perioperative data of patients, including basic information, intraoperative hemodynamic changes, postoperative inflammatory indicators, and adverse reactions were obtained through the electronic medical record system. According to the protocol of airway management during anesthesia, participants were divided into the following groups: laryngeal mask with spontaneous breathing group (LMSB group), laryngeal mask combined with bronchial blocker group (LM + BB group), double-lumen tube group (DLT group), and tracheal tube combined with bronchial blocker group (TT + BB group). All data were analyzed using SPSS 25.0 software. At baseline, patients in the LMSB and LM + BB groups had a lower body weight ( = 0.024). Systolic blood pressure (SBP), diastolic BP (DBP), and heart rate (HR) were significantly higher in the DLT group than in the non-intubated group during surgery (SBP: T1 = 0.048, T4 = 0.021, T5 ≤ 0.001, T6 ≤ 0.001, T7 = 0.004; DBP: T5 ≤ 0.001, T6 ≤ 0.001, T7 ≤ 0.001; HR: T1 = 0.021, T6 ≤ 0.001, T7 = 0.007, T8 ≤ 0.001). The input fluid ( = 0.009), urine output ( = 0.010), surgery duration ( = 0.035), and procalcitonin levels ( = 0.024) of the DLT group were also significantly higher than those of the other groups. The recovery duration of the LMSB group was significantly longer ( = 0.003) and the incidence of postoperative adverse reactions, mainly atelectasis, was higher ( = 0.012) than those of the other groups. Although the intubation-free anesthesia has less stimulation during operation and less postoperative inflammatory response, it has obvious adverse reactions after operation, which may be not the best anesthesia scheme for radical resection of lung cancer in VATS. https://www.chictr.org.cn/showproj.html?proj=182767, identifier ChiCTR2200066180.
A feasibility study to assess vallecula and pyriform sinus using protocol-based ultrasonic evaluation of floor of mouth and upper airway
Purpose: The current study aimed to systematically evaluate the sonoanatomy of floor of the mouth and upper airway using protocol-based ultrasonography (USG); and to assess the feasibility of imaging the valleculae and pyriform fossae. Materials and Methods: An institutional prospective observational study was planned on fifty volunteers of all ages and both sexes, attending outpatient department for nonairway-related diseases. Protocol for ultrasonographic systemic evaluation was designed before starting the trial. All the patients were positioned supine with neck extended (sniffing position), seven steps of ultrasonographic protocol were followed and visualization of structures denoted in each step was documented. Furthermore, time taken to complete each scan was noted. Results: The USG was completed, and checklist successfully followed in all cases. Floor of mouth structures was easy to evaluate and visualized with ease in all the cases. Epiglottis was visualized in 100% cases in transverse plane. Valleculae and pyriform fossae were identified in 82% and 90% of the cases, respectively, and they appeared either as paired air-filled round structures or air-lined linear structures. Complete visualization of vocal cords was seen in 78% females and 63% males. The average time taken to complete the protocol-based study was 10.4 ± 1.4 min. Conclusions: Application of protocol-based USG for upper airway can allow the examination of structures from tongue to thyroid cartilage in a thorough, convenient, and timely manner. The air filled/lined structures such as valleculae, pyriform fossae, and vocal cords can be visualized in majority of the cases.
Cuff leak test and airway obstruction in mechanically ventilated ICU patients (COSMIC): a pilot feasibility randomized controlled trial protocol
IntroductionThe cuff leak test (CLT) is hypothesised to help optimise extubation by assessing for laryngeal oedema which, if unrecognised and untreated, could lead to post-extubation stridor, post-extubation airway obstruction, and reintubation. However, the diagnostic accuracy of the CLT to detect post-extubation stridor (and hence potentially airway obstruction) remains uncertain. Given the equipoise that exists surrounding the CLT, we are conducting a pilot randomised clinical trial (RCT) examining the CLT as part of the pathway to extubation. Herein, we report the protocol for the Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): a Pilot Feasibility Randomized Clinical trial (RCT).Methods and analysisThis is a multicentre, international, parallel-group, pragmatic, pilot RCT. We will enrol 100 mechanically ventilated patients in the intensive care unit (ICU) who are deemed ready for extubation and have at least one risk factor for laryngeal oedema. In the intervention arm, respiratory therapists will perform a qualitative CLT before extubation. If a patient passes the CLT (suggesting no laryngeal oedema), extubation will be performed in keeping with standard care. If the patient fails the CLT (suggesting laryngeal oedema), extubation will be delayed allowing for administration of dexamethasone, consideration of diuresis, and the CLT will be repeated in 12–24 hours. In the control arm, patients will be extubated without completing a CLT, without steroid administration, and without delay. Randomization will be by a 1:1 allocation, stratified by centre. The primary feasibility outcomes will include recruitment and protocol adherence. Secondary outcomes will include post-extubation stridor, reintubation within 72 hours, emergency surgical airway within 72 hours, and ICU and hospital mortality within 30 days.Ethics and disseminationThis trial has been approved by Clinical Trials Ontario, Hamilton Integrated Research Ethics Board, State of Kuwait Ministry of Health, University of Texas Health Committee for the Protection of Human Subjects and Brant Community Health Systems Research Ethics Committee. The trial has received a No Objection Letter from Health Canada. Trial results will be disseminated via publication in peer-reviewed journals.Trial registration numberNCT05456542.
Clinical efficacy of COMBO endoscopy of oropharyngeal airways in elderly patients undergoing painless gastroenteroscopy under anaesthesia: a randomized controlled trial protocol
Background Respiratory depression and airway obstruction are the most common respiratory adverse reactions in elderly patients undergoing gastroenteroscopy under sedation. Additionally, sharing the airway with endoscopists can complicate airway management. Here, we plan to apply COMBO (Capnography Monitoring Bite Block Oxygenation) endoscopy of the oropharyngeal airway, a novel airway management device with integrated capnography monitoring and dual oxygenation support, to investigate the incidence of adverse events such as hypoxaemia and airway obstruction in elderly patients during anaesthesia, providing a reference for airway management in clinical practice. Methods and findings This will be a prospective, randomized, controlled clinical study. We will enrol 164 elderly patients (aged 65–80 years) scheduled for painless gastroenteroscopy. The participants will be randomly assigned to two groups. In the experimental group, an oropharyngeal airway designed for gastroscopy will be used. The control group will receive an ordinary endoscopic bite block. The primary outcome measure will be the incidence of hypoxia (75% ≤ SpO2 < 90%, ≤ 60 s), and the secondary outcome measures will be the incidence of severe hypoxia (SpO2 < 75% or 75% ≤SpO2 < 90%, ≥ 60 s); incidence of circulatory fluctuations [severe bradycardia (< 50 beats/min), a mean arterial pressure (MAP) fluctuation greater than 30% of the baseline value or an MAP < 60 mmHg]; incidence of airway intervention; dose of additional drugs administered during the procedure; endoscopist satisfaction; and incidence of various adverse events. Results This clinical study aims to evaluate whether an oropharyngeal airway dedicated to gastroscopy can effectively maintain airway patency and alleviate retrolingual collapse, thereby preventing hypoxaemia. It also aims to determine whether it can reduce the incidence of respiratory-related adverse events. Trial Registration This clinical trial protocol was formally registered at ClinicalTrials.gov (Registration Number: NCT06711328) on November 26, 2024.
Veno-venous extracorporeal membrane oxygenation as a bridge in central airway obstruction: experience from a high-volume center
Background Perioperative airway management and oxygenation maintenance during central airway obstruction (CAO) treatment pose great challenges. While veno-venous extracorporeal membrane oxygenation (V-V ECMO) shows promise as a bridge therapy, optimal implementation and management strategies remain lacking. We present our experience with V-V ECMO in CAO management from a high-volume center. Methods We retrospectively analyzed 29 consecutive patients who received V-V ECMO support for CAO between 2015 and 2023. Patient demographics, clinical characteristics, ECMO cannulation and operation parameters, interventional procedures, complications, and outcomes were reviewed. Results Among patients with median airway diameter of 4.5 mm (IQR 2–5 mm), etiologies included primary tumors (n = 17), metastases (n = 7), and post-intubation/tracheostomy stenosis (n = 5). Treatment comprised bronchoscopic interventions (n = 9) and surgical procedures (thoracic = 15, head/neck = 5). Using predominantly femoral-jugular cannulation (n = 27), we implemented a minimal anticoagulation protocol (catheter flush with 5U/mL heparin only). All patients survived through 6-month follow-up with minimal ECMO-related complications. Conclusion The application of V-V ECMO with minimal anticoagulation demonstrates safety and efficacy as a bridging support in the therapeutic approach to CAO.
Effectiveness of steroids versus placebo in preventing upper airway obstruction after extubation in critically ill children: rationale and design of a multicentric, double-blind, randomized study
Background Post-extubation upper airway obstruction (UAO) is a frequent complication causing stridor and respiratory distress, which occasionally require reintubation, thereby increasing morbidity and mortality rates. Contradictory results have been obtained in studies assessing the effectiveness of steroids in preventing post-extubation UAO, and the available evidence is limited. We designed a multicentric randomized, placebo-controlled study to explore the effectiveness of dexamethasone in preventing post-extubation UAO in children. Methods A multicentric, prospective, double-blind, randomized, placebo-controlled, phase IV clinical trial has been designed. The sample will include pediatric patients who are between 1 month and 16 years of age and who have been intubated for more than 48 h. Patients who have airway disorders or who have received steroids within the previous seven days will be excluded. Patients will be randomly assigned to receive either placebo or a therapy with dexamethasone 0.25 mg/kg every 6 h to be started 6 to 12 h prior to extubation (to a total of four doses). Randomization will be performed at a 1:1 ratio. Follow-up of patients will be carried out for 48 h after extubation. The main objective of this study is to access the reduction in the incidence of moderate to severe UAO symptoms following extubation. Secondary objectives include assessing the decrease in the incidence of reintubation, evaluating the use of additional therapies for UAO, and monitoring potential side effects of dexamethasone. Discussion The results of this study will contribute to the existing evidence on prophylaxis for post-extubation airway obstruction. Trial registration EudraCT identifier: 2009–016596-30 . Registered on May 11, 2010.
Clinical effects of the use of a novel oropharyngeal airway in painless gastroscopy in patients with obstructive sleep apnoea–hypopnoea syndrome: a randomised controlled trial protocol
IntroductionObstructive sleep apnoea–hypopnoea syndrome (OSAHS) is a sleep-related breathing disorder characterised by partial or complete obstruction of the upper respiratory tract. Owing to their relevant physiological anatomy, patients with OSAHS often experience severe respiratory complications, such as airway obstruction and hypoxaemia, during painless gastroscopy. In addition, the use of the shared airway approach increases the difficulty of airway management. At present, simple and effective tools for airway management for use during gastroscopy in clinical practice are lacking. Therefore, the aim of this study is to investigate whether a novel oropharyngeal airway designed for use in endoscopy can effectively relieve airway obstruction and prevent hypoxaemia.Method and analysisIn this prospective, randomised, controlled clinical study, 130 patients with OSAHS diagnosed via polysomnography monitoring will be randomly divided into two groups. The experimental group will receive the novel oropharyngeal airway, whereas the control group will receive a conventional bite block. The primary outcome will be the incidence of hypoxia (75%≤SpO2 (pulse oxygen saturation)<90%, ≤60 s), and the secondary outcome measure will be the incidence of severe hypoxia (SpO2<75% or 75%≤SpO2<90%, ≥60 s). The rate of airway intervention, the doses of additional drugs used during the operation, endoscopist and patient satisfaction with the procedure, and the incidence of various adverse events will be recorded.Ethics and disseminationThe Institutional Review Committee of the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) approved the experimental protocol on 22 August 2024 (ethics number: YXLL-KY-2024(084)). The results of this study will be reported in peer-reviewed journals and relevant academic conferences or related research platforms.Trial registration numberNCT06594380.
Efficacy and safety of the COMBO endoscopy oropharyngeal airway in gastrointestinal endoscopy: a study protocol for a multicenter randomized controlled trial
Background Hypoxia is one of the most common adverse events of sedated gastrointestinal (GI) endoscopy. It can cause coronary ischemia and permanent nervous system damage, potentially leading to death if not promptly addressed. This study aims to examine the efficacy and safety of the COMBO (capnography monitoring bite block oxygenation) endoscopy oropharyngeal airway in patients undergoing sedated GI endoscopy. Methods A multicenter randomized, open-label, two-arm parallel-group superiority clinical trial with an active comparator will be conducted to evaluate the impact of the COMBO endoscopy oropharyngeal airway on the incidence of hypoxia. This study will include patients ( n = 1200) undergoing GI endoscopy under propofol sedation. Written informed consent will be obtained from them. The participants (patients undergoing elective upper gastrointestinal endoscopic surgery, ≥ 18 years old and ≤ 60 years old, American Society of Anesthesiologists Grade I–II, expected inspection time ≤ 45 min) will be randomly assigned to a conventional nasal cannula (Arm 1)or the COMBO endoscopy oropharyngeal airway group (Arm 2). The intervention group will be administered the COMBO endoscopy oropharyngeal airway correspondingly. The primary objective is the incidence of hypoxia (75% ≤ SpO 2 < 90% for < 60 s). The secondary objective is the incidence rate of subclinical hypoxia (90% ≤ SpO 2 < 95%) and severe hypoxia (SpO 2 < 75% or 75% ≤ SpO 2 < 90% for ≥ 60 s), and other adverse events. Discussion The COMBO endoscopy oropharyngeal airway is a novel method for oxygenation and airway management. This study is aimed at investigating whether the COMBO endoscopy oropharyngeal airway can reduce the incidence of hypoxia in patients during gastrointestinal endoscopy under sedation with propofol. If successful, our proposal could play a pivotal role that represents a significant advancement in airway management in preventing hypoxemia during GI endoscopy under propofol sedation. Trial registration ClinicalTrials.gov NCT06081647, registered on October 15, 2023.
High-flow nasal cannula versus continuous positive airway pressure for initial respiratory support in very preterm infants: study protocol for a multicenter randomized controlled trial (SIMPLSAFE3)
Background Non-invasive continuous positive airway pressure (CPAP) is the standard initial respiratory support for preterm infants. However, requirements such as optimal pressure delivery and facemask repositioning, which trigger unwanted reflexes and bradycardia, often necessitate the use of positive pressure ventilation (PPV). Findings from a pilot study suggested that high-flow nasal cannula (HFNC) may be a promising alternative to CPAP, with lower PPV requirements. We hypothesize that HFNC is a safe, effective, and user-friendly alternative to CPAP for stabilizing very preterm infants (28 + 0–31 + 6 weeks of gestation), potentially reducing the need for PPV. We aim to compare HFNC and CPAP as initial respiratory support strategies at birth. Methods This is a multicenter, randomized, stepped-wedge cluster trial. Infants will receive either HFNC (8 L/min) or CPAP (6 cmH 2 O) immediately after birth with tactile stimulation. The fraction of inspired oxygen (FiO 2 ) will start at 0.30. PPV will be initiated if bradycardia or persistently low oxygen saturation (SpO 2 ) occurs. The primary outcome is stabilization with the assigned support without PPV administration. Secondary outcomes include (A) achievement of SpO 2  ≥ 80% at 5 min (with ≤ 2 brief PPV episodes) as a surrogate of safety and (B) achievement of SpO 2  > 90% with FiO 2  ≤ 0.40 at 10 min as a surrogate of efficacy. Overall, 446 infants will be recruited in both arms, with an estimated study duration of 2 years. Discussion The findings may inform future respiratory support guidelines for very preterm infants at birth. Trial registration ClinicalTrials.gov NCT06543589. Registered on August 9, 2024.