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The Effect of Preoperative Prone Position Training on PPCs in Patients Undergoing Laparoscopic Sleeve Gastrectomy

The Effect of Preoperative Prone Position Training on Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06023017
Enrollment
78
Registered
2023-09-05
Start date
2023-09-15
Completion date
2024-10-31
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pulmonary Complications

Keywords

pulmonary complications, prone position,sleeve gastrectomy

Brief summary

Postoperative pulmonary complications(PPCs) 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.

Detailed description

Postoperative pulmonary complications(PPCs) 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 40%,and 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 zone,homogenisation of transpulmonary pressure, improvement of ventilation/perfusion 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 addition,the 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 (GCP),and eligible participants are divided into two groups: group PPT and group C,and primary assess the incidence of PPCs after laparoscopic sleeve gastrectomy

Interventions

All patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training.

BEHAVIORALstandard perioperative care without any prone position training

Patients in the control group (C group) received standard perioperative care without any prone position training.

Sponsors

Min Su
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age over 18 years old * Body mass index(BMI)≥30 kg/m2 * Clinical diagnosis of metabolic syndrome, and undergoing Laparoscopic Sleeve Gastrectomy

Exclusion criteria

* Emergency surgery * Cognitive dysfunction * American Society of Anesthesiologists class ≥ IV * Fractures (face, collarbone, ribs, spine, limbs) * History of spontaneous pneumothorax * Increased intracranial pressure * pregnancy * Systemic infection * Patients with hemodynamic instability * Other conditions that are not suitable for prone position * Failure to obtain informed consent

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative pulmonary complications(PPCs)3 days after surgeryThe PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations

Secondary

MeasureTime frameDescription
arterial partial pressure of oxygen (PaO2)preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgeryBased on the blood gas analysis
arterial partial pressure of carbon dioxide (PaCO2)preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgeryBased on the blood gas analysis
oxygenation index (OI)preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgeryBased on the blood gas analysis
extubation time1 Day of surgeryextubation time in postanesthesia care unit(PACU)

Countries

China

Contacts

Primary ContactDong Zhang, Master
848138113@qq.com+86-023-89011069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026