Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers

Postoperative Complications Clinical Trial

— REMAIN-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556174
• Other study ID #: 2022ZSLYEC-398
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2022
• Est. completion date: May 2025

Study information

• Verified date: November 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Hong Li, MD
• Phone: 0086-020-38254070
• Email: lihong36[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1060
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery
• Intraoperative Mechanical Ventilation
• Postoperative Complications

Intervention

Other:
• periodic lung recruitment maneuvers
lung recruitment maneuvers repeated every 30 minutes

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dead space rate	Dead space rate (%)	Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Primary	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	Rate of mild respiratory failure	Mild respiratory failure: PaO2 < 60 mmHg or pulse oxygen saturation (SpO2) < 90% on room air, but SpO2 can be raised to more than 90% when inhaling oxygen through nasal catheter less than 3 L/min.	Day 0 to 7 after surgery
Secondary	Rate of moderate respiratory failure	Moderate respiratory failure: PaO2 < 60 mmHg or SpO2 < 90% when inhaling oxygen through nasal catheter less than 3 L/min, but SpO2 can be raised to more than 90% when inhaling oxygen more than 3 L/min.	Day 0 to 7 after surgery
Secondary	Rate of severe respiratory failure	Severe respiratory failure: experienced an invasive or noninvasive ventilator therapy, or PaO2 < 60 mmHg or SpO2 < 90% when administering oxygen via a nasal catheter at 3 L/min or more.	Day 0 to 7 after surgery
Secondary	Rate of sustained hypoxaemia	Sustained hypoxaemia: during a follow-up visit when the patient was awake and breathing room air, SpO2 = 92% or the change of SpO2 (?SpO2, preoperative SpO2 minus postoperative SpO2) = 5% on any three consecutive days.	Day 0 to 7 after surgery
Secondary	Rate of modified respiratory failure	Modified respiratory failure: met the criterion of moderate or severe respiratory failure, or mild respiratory failure in twice follow-up, or mild respiratory failure with sustained hypoxemia.	Day 0 to 7 after surgery
Secondary	Rate of respiratory infections	Respiratory infections: receiving antibiotics for a suspected respiratory infection and met at least one of the following criteria: new or changed sputum, new or changed lung opacities, fever, leukocyte count >12 × 109 /L	Day 0 to 7 after surgery
Secondary	Rate of pneumonia	Pneumonia: United States Centers for Disease Control definition of pneumonia	Day 0 to 7 after surgery
Secondary	Rate of aspiration pneumonitis	Aspiration pneumonitis: acute lung injury after the inhalation of regurgitated gastric contents.	Day 0 to 7 after surgery
Secondary	Rate of pneumothorax	Pneumothorax: air in the pleural space with no vascular bed surrounding the visceral pleura	Intraoperative or day 0 to 7 after surgery
Secondary	Rate of pleural effusion	Pleural effusion: chest radiograph demonstrating blunting of the costophrenic angle, loss of sharp silhouette of the ipsilateral hemidiaphragm in upright position, evidence of displacement of adjacent anatomical structures or (in supine position) a hazy opacity in one hemithorax with preserved vascular shadows	Day 0 to 7 after surgery
Secondary	Rate of Acute Respiratory Distress Syndrome	Acute Respiratory Distress Syndrome: The Berlin definition of Respiratory Distress Syndrome	Day 0 to 7 after surgery
Secondary	Rate of Quick Sequential Organ Failure Assessment (qSOFA) = 2	qSOFA = 2: Two or more of: Respiratory rate =22/min, Altered mentation, Systolic blood pressure = 100 mm Hg	Day 0 to 7 after surgery
Secondary	Rate of Systemic Inflammatory Response Syndrome (SIRS)	SIRS: Two or more of: Temperature >38°C or <36°C, Heart rate > 90/min, Respiratory rate >20/min or PaCO2<32 mmHg (4.3kPa), White blood cell count >12 000/mm3 or 10% immature bands	Day 0 to 7 after surgery
Secondary	Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)	MACCE: Stroke, coma, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure.	Day 0 to 7 after surgery
Secondary	Postoperative hospitalization days	The duration between the operation date and the actual discharge date, days	Day 0 to 30 after surgery
Secondary	Rate of Unexpected admission to intensive care unit (ICU)	Unexpected admission to ICU: It does not include patients who enter ICU at the request of surgeons but have normal spontaneous breathing, stable circulation and no disturbance of consciousness.	Day 0 to 30 after surgery
Secondary	Rate of death	Death from any cause	Day 0 to 30 after surgery
Secondary	Rate of intraoperative hypotension	Intraoperative hypotension: mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes	Intraoperative, period of mechanical ventilation
Secondary	Rate of intraoperative needing for vasoconstrictor	Intraoperative vasoconstrictor needs: MAP < 60 mmHg and using any catecholamines	Intraoperative, period of mechanical ventilation
Secondary	Rate of intraoperative hypoxemia	Intraoperative hypoxemia: SpO2 = 92% lasting more than 3 minutes	Intraoperative, period of mechanical ventilation
Secondary	Rate of Intraoperative bradycardia	Intraoperative bradycardia: heart rate = 50 bpm and the decrease of heart rate from the basic value = 20% lasting more than 3 minutes	Intraoperative, period of mechanical ventilation
Secondary	Rate of post-anesthesia care unit respiratory failure	Post-anesthesia care unit respiratory failure: PaO2 < 8 kPa (60 mmHg) on room air, a PaO2:FI02 ratio < 40 kPa (300 mmHg) or arterial oxyhaemoglobin saturation measured with pulse oximetry < 90% and requiring oxygen therapy	Postoperative, during postanesthesia care unit
Secondary	Intraoperative mechanical power	Mechanical power, J/min	Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Secondary	PaO2 / FI02	PaO2 / FI02, mmHg	Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Secondary	Postoperative pulmonary complications score	Postoperative pulmonary complications score: graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications).	Day 0 to 7 after surgery