Intraoperative Lung Protective Ventilation With or Without Periodic Lung Recruitment Maneuvers on Pulmonary Complications After Major Abdominal Surgery: a Prospective Randomized Controlled Study

Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country1,060 target enrollmentOctober 9, 2022

ConditionsPostoperative Complications Abdominal Surgery Intraoperative Mechanical Ventilation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Postoperative Complications
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Enrollment: 1060
Locations: 1
Primary Endpoint: Rate of respiratory failure
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Postoperative Pulmonary Complications (PPC) are common. It severely affects postoperative recovery, particularly in abdominal surgery. Several studies showed that intraoperative lung-protective ventilation with periodic lung recruitment maneuvers could reduce postoperative pulmonary complications. Other studies showed that intraoperative lung protective ventilation without periodic lung recruitment maneuvers could also reduce postoperative pulmonary complications. The purpose of this study was to compare the effects of the above two regimens on postoperative pulmonary complications.

Registry

clinicaltrials.gov

Start Date

October 9, 2022

End Date

November 11, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Undergoing elective major abdominal surgery (expected duration of mechanical ventilation ≥2 h)
•had an intermediate to high risk of developing postoperative pulmonary complications as indicated by an Assess Respiratory Risk in Surgical Patients in Catalonia score (≥26)
•Pulse oxygen saturation in room air ≥ 94%

Exclusion Criteria

•younger than 18 years
•had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery
•had a history of pneumonia within 1 month prior to surgery
•had severe chronic obstructive pulmonary disease or pulmonary bullae
•had a progressive neuromuscular illness
•severe heart dysfunction (New York Heart Association classification ≥4)
•with an American Society of Anesthesiologists (ASA) physical status of IV or higher
•Intracranial hypertension
•were pregnant (excluded by laboratory analysis)
•were involved in other interventional studies

Outcomes

Primary Outcomes

Rate of respiratory failure

Time Frame: Day 0 to 7 after surgery

Respiratory failure: postoperative arterial partial pressure of oxygen (PaO2) \< 8 kPa (60 mmHg) on room air, a PaO2: Inhaled oxygen concentration (FI02) ratio \< 40 kPa (300 mmHg) or arterial oxyhaemoglobin saturation measured with pulse oximetry \< 90% and requiring oxygen therapy

Secondary Outcomes

Rate of respiratory infections(Day 0 to 7 after surgery)
Rate of pleural effusion(Day 0 to 7 after surgery)
Rate of mild respiratory failure(Day 0 to 7 after surgery)
Rate of moderate respiratory failure(Day 0 to 7 after surgery)
Rate of sustained hypoxaemia(Day 0 to 7 after surgery)
Rate of pneumonia(Day 0 to 7 after surgery)
Rate of aspiration pneumonitis(Day 0 to 7 after surgery)
Rate of pneumothorax(Intraoperative or day 0 to 7 after surgery)
Rate of Acute Respiratory Distress Syndrome(Day 0 to 7 after surgery)
Rate of severe respiratory failure(Day 0 to 7 after surgery)
Rate of modified respiratory failure(Day 0 to 7 after surgery)
Postoperative pulmonary complications score(Day 0 to 7 after surgery)
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)(Day 0 to 7 after surgery)
Rate of death(Day 0 to 30 after surgery)
Rate of intraoperative needing for vasoconstrictor(Intraoperative, period of mechanical ventilation)
Intraoperative mechanical power(Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation)
Rate of Quick Sequential Organ Failure Assessment (qSOFA) ≥ 2(Day 0 to 7 after surgery)
Rate of Systemic Inflammatory Response Syndrome (SIRS)(Day 0 to 7 after surgery)
Rate of Intraoperative bradycardia(Intraoperative, period of mechanical ventilation)
Postoperative hospitalization days(Day 0 to 30 after surgery)
Rate of Unexpected admission to intensive care unit (ICU)(Day 0 to 30 after surgery)
Rate of intraoperative hypotension(Intraoperative, period of mechanical ventilation)
Rate of intraoperative hypoxemia(Intraoperative, period of mechanical ventilation)
Rate of post-anesthesia care unit respiratory failure(Postoperative, during postanesthesia care unit)
PaO2 / FI02(Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation)