Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers (REMAIN-1)

Sun Yat-sen University

Status: Completed

Conditions: Postoperative Complications; Intraoperative Mechanical Ventilation; Abdominal Surgery

Treatments: Other: periodic lung recruitment maneuvers

Study type: Interventional

Funder types: Other

Identifiers

NCT05556174

2022ZSLYEC-398

Details and patient eligibility

About

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.

Enrollment: 1,060 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Undergoing elective major abdominal surgery (expected duration of mechanical ventilation ≥2 h)
2. 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)
3. Pulse oxygen saturation in room air ≥ 94%

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,060 participants in 2 patient groups

Intensive intraoperative lung-protective ventilation

Experimental group

Description:

intraoperative lung-protective ventilation with periodic lung recruitment maneuvers

Treatment:

Other: periodic lung recruitment maneuvers

Moderate intraoperative lung-protective ventilation

No Intervention group

Description:

intraoperative lung-protective ventilation without periodic lung recruitment maneuvers