Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06023017
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-05
First Post:
2023-08-29
Brief Title:
The Effect of Preoperative Prone Position Training on PPCs in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Sponsor:
Min Su
Organization:
First Affiliated Hospital of Chongqing Medical University
Study Overview
Official Title:
The Effect of Preoperative Prone Position Training on Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postoperative pulmonary complicationsPPCs is a common complication in patients undergoing surgery under general anesthesia particularly in obese patients Relevant studies have shown that PPCs are more common in patients undergoing laparoscopic sleeve gastrectomy which contribute to significant increases in morbidity mortality length of postoperative hospital stay and medical consumption According to some reports the incidence of PPCs in obese patients after abdominal surgery is about 40 The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing pain longterm bed rest mucociliary clearance disorder and diaphragmatic dysfunction may be the main causes of PPCs
Numerous studies have demonstrated physiological improvement related to prone positioning Prone positioning consists of placing a patient face down Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome ARDS It has also been applied to non-intubated patients with acute respiratory failure ARF to improve oxygenation and delay or even avoid the need for invasive ventilation So the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of pulmonary complications after laparoscopic sleeve gastrectomy
Numerous studies have demonstrated physiological improvement related to prone positioning Prone positioning consists of placing a patient face down Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome ARDS It has also been applied to non-intubated patients with acute respiratory failure ARF to improve oxygenation and delay or even avoid the need for invasive ventilation So the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of pulmonary complications after laparoscopic sleeve gastrectomy
Detailed Description:
Postoperative pulmonary complicationsPPCs is a common complication in patients undergoing surgery under general anesthesia particularly in obese patients PPCs refer to the clinical abnormal changes in the lungs after surgery These include lung infections pneumonia atelectasis pleural effusion bronchospasm acute respiratory failure or acute respiratory distress syndrome ARDS Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications including hypoxemia and pneumonia Relevant studies have shown that PPCs are more common in patients undergoing laparoscopic sleeve gastrectomy which contribute to significant increases in morbidity mortality length of postoperative hospital stay and medical consumption According to some reports the incidence of PPCs in obese patients after abdominal surgery is about 40and our hospital preliminary investigation the incidence of PPCs in patients undergoing laparoscopic sleeve gastrectomy is approximately 30 The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing pain longterm bed rest mucociliary clearance disorder and diaphragmatic dysfunction may be the main causes of PPCs
Numerous studies have demonstrated physiological improvement related to prone positioning Prone positioning consists of placing a patient face down Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome ARDS It has also been applied to non-intubated patients with acute respiratory failure ARF to improve oxygenation and delay or even avoid the need for invasive ventilation
Currently the mechanisms of prone position training are decreased lung compression in the gravity dependant zonehomogenisation of transpulmonary pressure improvement of ventilationperfusion ratio and reduction of ventilator-induced lung injury VILI or patient self-inflicted lung injury P-SILI By placing the patient in the prone position the lungs compression due to its own weight is reduced via a gravitational-dependent redistribution of fluids In additionthe weight of the mediastinum is supported by the sternum the stiffer part of the chest At the same time the diaphragm is displaced caudally decreasing compression of the posterior-caudal lung parenchyma Finally in a triangular-shaped lung more parenchyma is included in the dorsal half than in the ventral one resulting in a more aerated lung in prone positioning
So the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of PPCs after laparoscopic sleeve gastrectomy
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University The protocol design is in accordance with Consolidated Standards of Reporting Trials CONSORT statement All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study This study is a prospective randomized controlled clinical trial guided by the standard of good clinical practice GCPand eligible participants are divided into two groups group PPT and group Cand primary assess the incidence of PPCs after laparoscopic sleeve gastrectomy
Numerous studies have demonstrated physiological improvement related to prone positioning Prone positioning consists of placing a patient face down Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome ARDS It has also been applied to non-intubated patients with acute respiratory failure ARF to improve oxygenation and delay or even avoid the need for invasive ventilation
Currently the mechanisms of prone position training are decreased lung compression in the gravity dependant zonehomogenisation of transpulmonary pressure improvement of ventilationperfusion ratio and reduction of ventilator-induced lung injury VILI or patient self-inflicted lung injury P-SILI By placing the patient in the prone position the lungs compression due to its own weight is reduced via a gravitational-dependent redistribution of fluids In additionthe weight of the mediastinum is supported by the sternum the stiffer part of the chest At the same time the diaphragm is displaced caudally decreasing compression of the posterior-caudal lung parenchyma Finally in a triangular-shaped lung more parenchyma is included in the dorsal half than in the ventral one resulting in a more aerated lung in prone positioning
So the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of PPCs after laparoscopic sleeve gastrectomy
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University The protocol design is in accordance with Consolidated Standards of Reporting Trials CONSORT statement All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study This study is a prospective randomized controlled clinical trial guided by the standard of good clinical practice GCPand eligible participants are divided into two groups group PPT and group Cand primary assess the incidence of PPCs after laparoscopic sleeve gastrectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None