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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Complication
• Intervention / Treatment: Behavioral: Prone Position Training; Behavioral: control group

Detailed Description

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. 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.

Postoperative pulmonary complications (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). 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 more than 40 years to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome (ARDS). Because of the positive physiological effects of prone positioning on transpulmonary pressure, lung compression and ventilation perfusion ratio, 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 pulmonary complications after laparoscopic colorectal cancer surgery.

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 pulmonary complications after laparoscopic colorectal cancer surgery.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Zhang, Master; Phone Number: +86-023-89011069; Email: 848138113@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age over 18 years old
• Clinical diagnosis of colorectal cancer

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
• Acute respiratory failure
• Patients with hemodynamic instability
• Other conditions that are not suitable for prone position
• Failure to obtain informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prone Position Training group (PPT group); 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; 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.
Placebo Comparator: Control group (C group); Patients in the control group (C group) received standard perioperative care without any prone position training.	Behavioral: control group; Patients in the control group (C group) received standard perioperative care without any prone position training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative pulmonary complications（PPCs）	The PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations	7 day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial partial pressure of oxygen (PaO2)	Based on the blood gas analysis	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	extubation time in postanesthesia care unit （PACU）	Day of surgery
Peak airway pressure	Airway pressure	Intraoperative
arterial partial pressure of carbon dioxide (PaCO2)	Based on the blood gas analysis	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)	Based on the blood gas analysis	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

Collaborators and Investigators

• Sponsor: Min Su
• Investigators: Principal Investigator: Su Min, MD, First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 21, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): September 6, 2024

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pulmonary complications, prone position , colorectal surgery
• Other Study ID Numbers: CQMUAZD2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No