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"Patient Positioning - statistics "
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Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial
2017
Background
The treatment of idiopathic full-thickness macular holes involves surgery to close the hole. Some surgeons advise patients to adopt a face-down position to increase the likelihood of successful macular hole closure. However, patients often find the face-down positioning arduous. There is a lack of conclusive evidence that face-down positioning improves the outcome. The ‘Positioning In Macular hole Surgery’ (PIMS) trial will assess whether advice to position face-down after surgery improves the surgical success rate for the closure of large (≥400 μm) macular holes.
Methods/design
The PIMS trial is a multicentre, parallel-group, superiority clinical trial with 1:1 randomisation. Patients (
n
= 192) with macular holes (≥400 μm) will be randomised after surgery to either face-down positioning or face-forward positioning for at least 8 h (which can be either consecutive or nonconsecutive) a day, for 5 days following surgery. Inclusion criteria are: presence of an idiopathic full-thickness macular hole ≥400 μm in diameter, as measured by optical coherence tomography (OCT) scans, on either or both eyes; patients electing to have surgery for a macular hole, with or without simultaneous phacoemulsification and intraocular lens implant; ability and willingness to position face-down or in an inactive face-forward position; a history of visual loss suggesting a macular hole of 12 months’ or less duration. The primary outcome is successful macular hole closure at 3 months post surgery. The treatment effect will be reported as an odds ratio with 95% confidence interval, adjusted for size of macular hole and phakic lens status at baseline. Secondary outcome measures at 3 months are: further surgery for macular holes performed or planned (of those with unsuccessful closure); patient-reported experience of positioning; whether patients report they would still have elected to have the operation given what they know at follow-up; best-corrected visual acuity (BCVA) measured using Snellen charts at a standard distance of 6 m; patient-reported health and quality of life assessed using the National Eye Institute Visual Function Questionnaire (VFQ-25).
Discussion
The PIMS trial is the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery.
Trial registration
International Standard Randomised Controlled Trials Number registry, ID: ISRCTN12410596. Registered on 11 February 2015.
United Kingdom Clinical Research Network, ID:
UKCRN17966
. Registered on 26 November 2014.
Journal Article
Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study
by
Ding, Lin
,
He, Hangyong
,
Wang, Li
in
Acute respiratory distress syndrome (ARDS)
,
Adult
,
Adult respiratory distress syndrome
2020
Background
Previous studies suggest that prone positioning (PP) can increase PaO
2
/FiO
2
and reduce mortality in moderate to severe acute respiratory distress syndrome (ARDS). The aim of our study was to determine whether the early use of PP combined with non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) can avoid the need for intubation in moderate to severe ARDS patients.
Methods
This prospective observational cohort study was performed in two teaching hospitals. Non-intubated moderate to severe ARDS patients were included and were placed in PP with NIV or with HFNC. The efficacy in improving oxygenation with four support methods—HFNC, HFNC+PP, NIV, NIV+PP—were evaluated by blood gas analysis. The primary outcome was the rate of intubation.
Results
Between January 2018 and April 2019, 20 ARDS patients were enrolled. The main causes of ARDS were pneumonia due to influenza (9 cases, 45%) and other viruses (2 cases, 10%). Ten cases were moderate ARDS and 10 cases were severe. Eleven patients avoided intubation (success group), and 9 patients were intubated (failure group). All 7 patients with a PaO
2
/FiO
2
< 100 mmHg on NIV required intubation. PaO
2
/FiO
2
in HFNC+PP were significantly higher in the success group than in the failure group (125 ± 41 mmHg vs 119 ± 19 mmHg,
P
= 0.043). PaO
2
/FiO
2
demonstrated an upward trend in patients with all four support strategies: HFNC < HFNC+PP ≤ NIV < NIV+PP. The average duration for PP was 2 h twice daily.
Conclusions
Early application of PP with HFNC, especially in patients with moderate ARDS and baseline SpO
2
> 95%, may help avoid intubation. The PP was well tolerated, and the efficacy on PaO
2
/FiO
2
of the four support strategies was HFNC < HFNC+PP ≤ NIV < NIV+PP. Severe ARDS patients were not appropriate candidates for HFNC/NIV+PP.
Trial registration
ChiCTR,
ChiCTR1900023564
. Registered 1 June 2019 (retrospectively registered)
Journal Article
The efficacy and safety of the left lateral position for endoscopic retrograde cholangiopancreatography
2017
Endoscopic retrograde cholangiopancreatography (ERCP) is typically performed in prone position. In cases of difficulty in prone position, ERCP can be performed in left lateral position. We aimed to evaluate the efficacy and safety of left lateral position for ERCP compared with those of prone position.
Between August 2015 and March 2016, a total of 62 patients with native papilla who underwent ERCP were randomly assigned to undergo the procedure in left lateral position (n = 31) or prone position (n = 31). The outcomes of procedures were compared between the two groups.
There were no significant differences between the two groups in terms of the demographic data, indications for ERCP, comorbidities, anticoagulation agents, the types and doses of sedative agents, and procedural durations. The rates of technical success and adverse events were similar (96.8 and 40%, respectively, in left lateral group and 100 and 32.3%, respectively, in prone group). The rates of unintentional pancreatic duct (PD) cannulation and the acquisition of pancreatograms in left lateral group were significantly greater than those in prone group (9/30, 30.0% vs. 3/31, 9.7%, P = 0.046; 7/30, 23.3% vs. 1/31, 3.2%, P = 0.020, respectively). However, there was no significant difference in the rate of post-ERCP pancreatitis (6/30, 20% vs. 5/31, 16.1%, P = 0.694).
The left lateral position for ERCP can be as effective and safe as prone position. Due to increased rates of unintended PD cannulation and contrast injection, the initial use of left lateral position may be limited to cases that exhibit difficulty in prone position.
Journal Article
Randomized Controlled Trials of Proximal Femoral Nail Antirotation in Lateral Decubitus and Supine Position on Treatment of Intertrochanteric Fractures
2013
The objective of this study was to compare the clinical results and complications of proximal femoral nail antirotation (PFNA) on treatment of intertrochanteric fractures in 120 elderly Chinese patients using Randomized Controlled Trials (RCTs). Totaly 120 cases enrolled were randomly assigned to a lateral decubitus position group and supine position group. The hospital stay, operating time, intraoperative blood loss, length of incision, X-ray fluoroscopy time, and out-of-bed activity time in the lateral decubitus position group were significantly lower than those in the supine position group. There was not statistical significance on union time and Harris values in the two position groups. Moreover, only complications of superficial wound infection were observed in the lateral decubitus position group, but two complications of deep venous thrombosis and wound deep infection were found in the supine position group. The present findings suggested that PFNA applied in elderly patients with intertrochanteric fracture can get satisfactory effects, and the treatment of intertrochanteric fractures using lateral decubitus position showed a satisfactory clinical outcome and a lower radiological complication rate.
Journal Article
Optimization based trajectory planning for real-time 6DoF robotic patient motion compensation systems
2019
Robotic stabilization of a therapeutic radiation beam with respect to a dynamically moving tumor target can be accomplished either by moving the radiation source, the patient, or both. As the treatment beam is on during this process, the primary goal is to minimize exposure of normal tissue to radiation as much as possible when moving the target back to the desired position. Due to the complex mechanical structure of 6 degree-of-freedom (6DoF) robots, it is not intuitive as to what 6 dimensional (6D) correction trajectory is optimal in achieving such a goal. With proportional-integrative-derivative (PID) and other controls, the potential exists that the controller may generate a trajectory that is highly curved, slow, or suboptimal in that it leads to unnecessary exposure of healthy tissue to radiation. This work investigates a novel feedback planning method that takes into account a robot's mechanical joint structure, patient safety tolerances, and other system constraints, and performs real-time optimization to search the entire 6D trajectory space in each time cycle so it can respond with an optimal 6D correction trajectory.
Computer simulations were created for two 6DoF robotic patient support systems: a Stewart-Gough platform for moving a patient's head in frameless maskless stereotactic radiosurgery, and a linear accelerator treatment table for moving a patient in prostate cancer radiation therapy. Motion planning was formulated as an optimization problem and solved at real-time speeds using the L-BFGS algorithm. Three planning methods were investigated, moving the platform as fast as possible (platform-D), moving the target along a straight-line (target-S), and moving the target based on the fastest descent of position error (target-D). Both synthetic motion and prior recorded human motion were used as input data and output results were analyzed.
For randomly generated 6D step-like and sinusoidal synthetic input motion, target-D planning demonstrated the smallest net trajectory error in all cases. On average, optimal planning was found to have a 45% smaller target trajectory error than platform-D control, and a 44% smaller target trajectory error than target-S planning. For patient head motion compensation, only target-D planning was able to maintain a ≤0.5mm and ≤0.5deg clinical tolerance objective for 100% of the treatment time. For prostate motion, both target-S planning and target-D planning outperformed platform-D control.
A general 6D target trajectory optimization framework for robotic patient motion compensation systems was investigated. The method was found to be flexible as it allows control over various performance requirements such as mechanical limits, velocities, acceleration, or other system control objectives.
Journal Article
Flexibility radiographs in pediatric spine surgery are often used but lack consistency
by
Heffernan, Michael J.
,
Hwang, Steven W.
,
Sponseller, Paul D.
in
Adolescent
,
Adult
,
Bone surgery
2025
Purpose
Despite agreement on the importance of spinal curvature flexibility in surgical decision making, there is no consensus regarding optimal radiographic assessment and how this impacts care. We sought to further understand traction film indications and techniques.
Methods
A nine-question survey was administered to 194 members of the Pediatric Spine Study Group (PSSG). The survey aimed to elucidate flexibility radiograph practices of pediatric spine surgeons and how these results inform operative plans and timing.
Results
Ninety-six of 194 (49.5%) respondents were included in the analysis. 96.9% (93/96) performed radiographic assessment of curve flexibility. Amongst these surgeons, roughly half (52.7%, 49/93) do so for surgical planning only (level selection, osteotomies, construct type, etc.), while 45.2% use them for both surgical planning and surgical timing.
Radiographs performed included: supine traction (68.8%, 64/93), supine bending (61.3%, 57/93), standing bending (39.8%, 37/93), supine without traction (20.4%, 19/93), and other (21.5%, 20/93). Supine traction films were typically performed by one person holding the legs and one pulling the arms (62.5%, 40/64) or pulling the chin or head (23.4%, 15/64). Traction is routinely applied by physicians (48.4%, 45/93), radiology technicians (39.8%, 37/93), and physician assistants (20.4%, 19/93). Nearly half (45.2%, 45/93) of surgeons feel that traction films are not a consistent or reproducible measure within their department, and 68.8% (64/93) feel that these films are not reproducible across institutions.
Conclusion
The marked variability observed amongst institutional practices and concerns about reproducibility within and across departments warrant the development of a more standardized method to assess curve flexibility.
Journal Article
Recovery position significantly associated with a reduced admission rate of children with loss of consciousness
by
Lejay, Emilie
,
Julliand, Sebastien
,
Van De Voorde, Patrick
in
Adolescent
,
Airway Obstruction - prevention & control
,
Caregivers
2016
BackgroundLoss of consciousness (LOC) is often seen in children. The response of caregivers to a child with LOC has been poorly investigated. Potential caregivers (parents, teachers) seem to have a poor knowledge of the recovery position (RP)—that is, the position into which an unconscious child should be placed in order to protect the airway.ObjectivesTo report the management and diagnoses of LOC in childhood, and to evaluate variables associated with an increased hospital admission rate.MethodsWe conducted a prospective cohort study of consecutive children aged between 0 and 18 years diagnosed with LOC at 11 paediatric emergency departments (PEDs) of 6 European countries. The enrolment period was 3 months. Data were obtained from parental interviews, PED reports and clinical examination.Results553 children were enrolled. The most frequent final diagnoses causing LOC were seizures (n=278, 50.3%), and vasovagal syncope (n=124, 22.4%). Caregivers put the child in the RP in 145 cases (26.2%). The RP was independently associated with a significant decrease in the admission rate (aOR=0.28; 95% CI 0.17 to 0.48; p<0.0001).ConclusionsOur study demonstrates for the first time that the RP may reduce the admission rate of infants with LOC. Caregivers often perform inadequate manoeuvres when a child becomes unconscious. Campaigns aiming at increasing knowledge of the RP should be promoted.
Journal Article
Prone Positioning in Non-Intubated Patients With COVID-19 Outside of the Intensive Care Unit: More Evidence Needed
by
Ripoll-Gallardo, Alba
,
Grillenzoni, Luca
,
Bollon, Jordy
in
Adult
,
Aged
,
Cardiovascular disease
2020
The coronavirus disease (COVID-19) pandemic has brought the Italian National Health System to its knees. The abnormally high influx of patients, together with the limited resources available, has forced clinicians to make unprecedented decisions and provide compassionate treatments for which little or no evidence is yet available. This is the case for the use of noninvasive positive pressure ventilation and continuous airway pressure ventilation, combined with prone position in patients with COVID-19 and acute respiratory distress syndrome treated outside of intensive care units. In our article, we comment on the evidence available, so far, and provide a brief summary of data collected at our health institution in Piedmont, Italy.
Journal Article
The impact of a prophylactic skin dressing on surface‐guided patient positioning in chest wall Radiation Therapy
2024
Introduction Surface‐guided radiation therapy (SGRT) has emerged as a powerful tool to improve patient setup accuracy in radiation therapy (RT). Combined with the goal of increasing RT accuracy is an ongoing effort to decrease RT side effects. The application of a prophylactic skin dressing to the treatment site is a well‐documented method of reducing skin‐related side effects from RT. This paper aims to investigate whether the application of Mepitel, a prophylactic skin dressing, has an impact on the accuracy of surface‐guided patient setups in chest wall RT. Methods A retrospective analysis of daily image‐guided Online Corrections (OLCs) from patients undergoing chest wall irradiation with SGRT was performed. Translational (superior–inferior, lateral, and anterior–posterior) OLC magnitude and direction were compared between patients treated with Mepitel applied and those treated without. Systematic and random errors were calculated and compared between groups. Results OLCs from 275 fractions were analysed. Mean OLCs were larger for patients with Mepitel applied in the superior_inferior axis (0.34 vs. 0.22 cm, P = 0.049) and for the combined translational vector (0.54 vs. 0.43 cm, P = 0.043). Combined translational systematic error was slightly larger for patients with Mepitel applied (0.15 vs. 0.09 cm). Conclusion Mepitel can impact the accuracy of SGRT patient‐positioning in chest wall RT. The variation however is small and unlikely to have any clinical impact if SGRT is coupled with image guidance and appropriate PTV margins. Further investigation is required to assess the effect of Mepitel on SGRT accuracy in other treatment sites, as well as any potential dosimetric impacts. Surface‐guided radiation therapy is used widely for chest wall radiation therapy (RT). This paper investigated whether Mepitel, a barrier film commonly used to prevent radiation dermatitis, can impact the accuracy of surface‐guided patient setups in chest wall RT by analysing image‐guided RT trends. Whilst a statistically significant impact was found, it is unlikely to be clinically significant.
Journal Article
Preliminary study on clinical characteristics of Chinese patients with positional obstructive sleep apnea
2022
PurposeThe objective of this study was to evaluate the prevalence, the clinical characteristics, and the possible predictors of Chinese patients with positional obstructive sleep apnea (POSA) according to the Amsterdam Positional Obstructive Sleep Apnea Classification (APOC).MethodsA retrospective study in the sleep unit of Peking Union Medical College Hospital was conducted to analyze the clinical and polysomnography data of Chinese patients with obstructive sleep apnea (OSA).ResultsOf 372 patients with OSA, 54% met the APOC criteria for POSA. The prevalence of POSA was significantly higher in women with OSA than in men. Chinese patients with POSA had a lower apnea–hypopnea index, oxygen desaturation index, and the percentage of time spent at oxygen saturation below 90% in total sleep time; and a higher mean oxygen saturation (SaO2) and minimum SaO2 during sleep, which were remarkable in the APOC I group. By multivariate logistic regression analyses, the higher mean SaO2 (≥95%) during sleep and mild and moderate OSA were positive predictors of POSA. Mild and moderate OSA was the independent predictor of POSA in women. Higher mean SaO2 (≥95%) during sleep was the independent predictor of POSA in men.ConclusionAccording to the APOC, the prevalence of POSA is high in Chinese patients with OSA, especially in women. Chinese patients with POSA had less severe OSA and a lower degree of nocturnal hypoxia, which was remarkable in the APOC I group.
Journal Article