Clinical trial NCT05556174: Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers
Official title: Intraoperative Lung Protective Ventilation With or Without Periodic Lung Recruitment Maneuvers on Pulmonary Complications After Major Abdominal Surgery: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Abdominal Surgery
Intraoperative Mechanical Ventilation
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of respiratory failure
timeFrame: Day 0 to 7 after surgery
Secondary outcomes:
measure: Rate of mild respiratory failure
timeFrame: Day 0 to 7 after surgery
measure: Rate of moderate respiratory failure
timeFrame: Day 0 to 7 after surgery
measure: Rate of severe respiratory failure
timeFrame: Day 0 to 7 after surgery
measure: Rate of sustained hypoxaemia
timeFrame: Day 0 to 7 after surgery
measure: Rate of modified respiratory failure
timeFrame: Day 0 to 7 after surgery
measure: Rate of respiratory infections
timeFrame: Day 0 to 7 after surgery
measure: Rate of pneumonia
timeFrame: Day 0 to 7 after surgery
measure: Rate of aspiration pneumonitis
timeFrame: Day 0 to 7 after surgery
measure: Rate of pneumothorax
timeFrame: Intraoperative or day 0 to 7 after surgery
measure: Rate of pleural effusion
timeFrame: Day 0 to 7 after surgery
measure: Rate of Acute Respiratory Distress Syndrome
timeFrame: Day 0 to 7 after surgery
measure: Rate of Quick Sequential Organ Failure Assessment (qSOFA) ≥ 2
timeFrame: Day 0 to 7 after surgery
measure: Rate of Systemic Inflammatory Response Syndrome (SIRS)
timeFrame: Day 0 to 7 after surgery
measure: Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: Day 0 to 7 after surgery
measure: Postoperative hospitalization days
timeFrame: Day 0 to 30 after surgery
measure: Rate of Unexpected admission to intensive care unit (ICU)
timeFrame: Day 0 to 30 after surgery
measure: Rate of death
timeFrame: Day 0 to 30 after surgery
measure: Rate of intraoperative hypotension
timeFrame: Intraoperative, period of mechanical ventilation
measure: Rate of intraoperative needing for vasoconstrictor
timeFrame: Intraoperative, period of mechanical ventilation
measure: Rate of intraoperative hypoxemia
timeFrame: Intraoperative, period of mechanical ventilation
measure: Rate of Intraoperative bradycardia
timeFrame: Intraoperative, period of mechanical ventilation
measure: Rate of post-anesthesia care unit respiratory failure
timeFrame: Postoperative, during postanesthesia care unit
measure: Intraoperative mechanical power
timeFrame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
measure: PaO2 / FI02
timeFrame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
measure: Postoperative pulmonary complications score
timeFrame: Day 0 to 7 after surgery
Other outcomes:
measure: Dead space rate
timeFrame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Hong Li, MD
role: PRINCIPAL_INVESTIGATOR
References: