Effect of Prone Position Training on Pulmonary Complications in Patients Undergoing Laparoscopic Colorectal Surgery

NCT06001411 | Unknown

• 1 other identifier: CQMUAZD2023
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is a common digestive tract tumor in China. At present, laparoscopic surgery has become the classic operation of colorectal cancer surgery compared with the traditional open abdominal surgery. Although laparoscopic surgery has many advantages, such as less pain, faster recovery and so on. However, relevant studies have shown that postoperative pulmonary complications are more common in patients undergoing Laparoscopic Colorectal Surgery, which contribute to significant increases in morbidity, mortality, length of postoperative hospital stay and medical consumption. The incidence of pulmonary complications after abdominal surgery has been reported to be between 9% and 40%. The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing, pain, long-term bed rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of postoperative pulmonary complications. 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 colorectal cancer surgery.

Conditions

Pulmonary Complication

Keywords

pulmonary complications, prone position , colorectal surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative pulmonary complications（PPCs）

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

  7 day after surgery

Secondary Outcomes (5)

• 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

• extubation time

  Day of surgery

• Peak airway pressure

  Intraoperative

• 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

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: control group

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)

control group 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
• Clinical diagnosis of colorectal cancer

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
• Acute respiratory failure
• 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)

China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

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: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 21, 2023
• Study Start: August 21, 2023
• Primary Completion: August 30, 2024
• Study Completion: September 6, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

CN (1)