Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers

NCT05556174 | Completed DMC

• 1 other identifier: 2022ZSLYEC-398
• Study Type: interventional
• Target: 1,060
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Abdominal Surgery; Intraoperative Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Rate of respiratory failure

  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

  Day 0 to 7 after surgery

Secondary Outcomes (25)

• Rate of mild respiratory failure

  Day 0 to 7 after surgery

• Rate of moderate respiratory failure

  Day 0 to 7 after surgery

• Rate of severe respiratory failure

  Day 0 to 7 after surgery

• Rate of sustained hypoxaemia

  Day 0 to 7 after surgery

• Rate of modified respiratory failure

  Day 0 to 7 after surgery

Other Outcomes (1)

• Dead space rate

  Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation

Study Arms (2)

Intensive intraoperative lung-protective ventilation

EXPERIMENTAL

intraoperative lung-protective ventilation with periodic lung recruitment maneuvers

Other: periodic lung recruitment maneuvers

Moderate intraoperative lung-protective ventilation

NO INTERVENTION

intraoperative lung-protective ventilation without periodic lung recruitment maneuvers

Interventions

periodic lung recruitment maneuvers OTHER

lung recruitment maneuvers repeated every 30 minutes

Intensive intraoperative lung-protective ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (1)

• Zhang NR, Zhang LZ, Chen Y, Zhang S, Li S, Gu XK, Li J, Li H. Intraoperative protective ventilation with or without periodic lung recruitment manoeuvres on pulmonary complications after major abdominal surgery (REMAIN-1): protocol for a randomised controlled trial. BMJ Open. 2025 Mar 13;15(3):e093360. doi: 10.1136/bmjopen-2024-093360.

  PMID: 40082005 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hong Li, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 27, 2022
• Study Start: October 9, 2022
• Primary Completion: September 11, 2024
• Study Completion: November 11, 2024
• Last Updated: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)