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

NCT06023017 | Unknown

• 1 other identifier: CQMUAZD2023-2
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pulmonary Complications

Keywords

pulmonary complications, prone position,sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative pulmonary complications(PPCs)

  The PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations

  3 days after surgery

Secondary Outcomes (4)

• 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 surgery

• 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 surgery

• 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 surgery

• extubation time

  1 Day of surgery

Study Arms (2)

Prone Position Training group (PPT group)

EXPERIMENTAL

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.

Behavioral: Prone Position Training

Control group (C group)

PLACEBO COMPARATOR

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

Behavioral: standard perioperative care without any prone position training

Interventions

Prone Position Training BEHAVIORAL

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.

Prone Position Training group (PPT group)

standard perioperative care without any prone position training BEHAVIORAL

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

Control group (C group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Min Su: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Study Officials

• Su Min, MD

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Zhang, Master

CONTACT

+86-023-89011069; 848138113@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: September 15, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

CN (1)