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

Pulmonary Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06001411
• Other study ID #: CQMUAZD2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: September 6, 2024

Study information

• Verified date: August 2023
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Dong Zhang, Master
• Phone: +86-023-89011069
• Email: 848138113[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 6, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Complication

Intervention

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

Locations

Country	Name	City	State
China	China,Chongqing The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Min Su

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative pulmonary complications(PPCs)	The PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations	7 day after surgery
Secondary	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
Secondary	extubation time	extubation time in postanesthesia care unit (PACU)	Day of surgery
Secondary	Peak airway pressure	Airway pressure	Intraoperative
Secondary	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
Secondary	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