Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-09

Study Completion Date

2024-11-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Complications Abdominal Surgery Intraoperative Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intensive intraoperative lung-protective ventilation

intraoperative lung-protective ventilation with periodic lung recruitment maneuvers

Group Type EXPERIMENTAL

periodic lung recruitment maneuvers

Intervention Type OTHER

lung recruitment maneuvers repeated every 30 minutes

Moderate intraoperative lung-protective ventilation

intraoperative lung-protective ventilation without periodic lung recruitment maneuvers

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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periodic lung recruitment maneuvers

lung recruitment maneuvers repeated every 30 minutes

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No