Back to resultsIntraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers (REMAIN-1)
Primary Purpose
Postoperative Complications, Abdominal Surgery, Intraoperative Mechanical Ventilation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
periodic lung recruitment maneuvers
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications
Eligibility Criteria
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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
Sites / Locations
- The Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intensive intraoperative lung-protective ventilation
Moderate intraoperative lung-protective ventilation
Arm Description
intraoperative lung-protective ventilation with periodic lung recruitment maneuvers
intraoperative lung-protective ventilation without periodic lung recruitment maneuvers
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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 (ΔSpO2, preoperative SpO2 minus postoperative SpO2) ≥ 5% on any three consecutive days.
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.
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
Rate of pneumonia
Pneumonia: United States Centers for Disease Control definition of pneumonia
Rate of aspiration pneumonitis
Aspiration pneumonitis: acute lung injury after the inhalation of regurgitated gastric contents.
Rate of pneumothorax
Pneumothorax: air in the pleural space with no vascular bed surrounding the visceral pleura
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
Rate of Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome: The Berlin definition of Respiratory Distress Syndrome
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
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
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE: Stroke, coma, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure.
Postoperative hospitalization days
The duration between the operation date and the actual discharge date, days
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.
Rate of death
Death from any cause
Rate of intraoperative hypotension
Intraoperative hypotension: mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes
Rate of intraoperative needing for vasoconstrictor
Intraoperative vasoconstrictor needs: MAP < 60 mmHg and using any catecholamines
Rate of intraoperative hypoxemia
Intraoperative hypoxemia: SpO2 ≤ 92% lasting more than 3 minutes
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
Rate of LRM1 related MAP changes ≥ 10%
The MAP changes between intra or 3 min after LRM1 and pre-LRM1
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
Intraoperative mechanical power
Mechanical power, J/min
PaO2 / FI02
PaO2 / FI02, mmHg
Full Information
NCT ID
NCT05556174
First Posted
September 14, 2022
Last Updated
November 19, 2022
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05556174
Brief Title
Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Abdominal Surgery, Intraoperative Mechanical Ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1060 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive intraoperative lung-protective ventilation
Arm Type
Experimental
Arm Description
intraoperative lung-protective ventilation with periodic lung recruitment maneuvers
Arm Title
Moderate intraoperative lung-protective ventilation
Arm Type
No Intervention
Arm Description
intraoperative lung-protective ventilation without periodic lung recruitment maneuvers
Intervention Type
Other
Intervention Name(s)
periodic lung recruitment maneuvers
Intervention Description
lung recruitment maneuvers repeated every 30 minutes
Primary Outcome Measure Information:
Title
Rate of respiratory failure
Description
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
Time Frame
Day 0 to 7 after surgery
Secondary Outcome Measure Information:
Title
Rate of mild respiratory failure
Description
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.
Time Frame
Day 0 to 7 after surgery
Title
Rate of moderate respiratory failure
Description
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.
Time Frame
Day 0 to 7 after surgery
Title
Rate of severe respiratory failure
Description
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.
Time Frame
Day 0 to 7 after surgery
Title
Rate of sustained hypoxaemia
Description
Sustained hypoxaemia: during a follow-up visit when the patient was awake and breathing room air, SpO2 ≤ 92% or the change of SpO2 (ΔSpO2, preoperative SpO2 minus postoperative SpO2) ≥ 5% on any three consecutive days.
Time Frame
Day 0 to 7 after surgery
Title
Rate of modified respiratory failure
Description
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.
Time Frame
Day 0 to 7 after surgery
Title
Rate of respiratory infections
Description
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
Time Frame
Day 0 to 7 after surgery
Title
Rate of pneumonia
Description
Pneumonia: United States Centers for Disease Control definition of pneumonia
Time Frame
Day 0 to 7 after surgery
Title
Rate of aspiration pneumonitis
Description
Aspiration pneumonitis: acute lung injury after the inhalation of regurgitated gastric contents.
Time Frame
Day 0 to 7 after surgery
Title
Rate of pneumothorax
Description
Pneumothorax: air in the pleural space with no vascular bed surrounding the visceral pleura
Time Frame
Intraoperative or day 0 to 7 after surgery
Title
Rate of pleural effusion
Description
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
Time Frame
Day 0 to 7 after surgery
Title
Rate of Acute Respiratory Distress Syndrome
Description
Acute Respiratory Distress Syndrome: The Berlin definition of Respiratory Distress Syndrome
Time Frame
Day 0 to 7 after surgery
Title
Rate of Quick Sequential Organ Failure Assessment (qSOFA) ≥ 2
Description
qSOFA ≥ 2: Two or more of: Respiratory rate ≥22/min, Altered mentation, Systolic blood pressure ≤ 100 mm Hg
Time Frame
Day 0 to 7 after surgery
Title
Rate of Systemic Inflammatory Response Syndrome (SIRS)
Description
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
Time Frame
Day 0 to 7 after surgery
Title
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Description
MACCE: Stroke, coma, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure.
Time Frame
Day 0 to 7 after surgery
Title
Postoperative hospitalization days
Description
The duration between the operation date and the actual discharge date, days
Time Frame
Day 0 to 30 after surgery
Title
Rate of Unexpected admission to intensive care unit (ICU)
Description
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.
Time Frame
Day 0 to 30 after surgery
Title
Rate of death
Description
Death from any cause
Time Frame
Day 0 to 30 after surgery
Title
Rate of intraoperative hypotension
Description
Intraoperative hypotension: mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes
Time Frame
Intraoperative, period of mechanical ventilation
Title
Rate of intraoperative needing for vasoconstrictor
Description
Intraoperative vasoconstrictor needs: MAP < 60 mmHg and using any catecholamines
Time Frame
Intraoperative, period of mechanical ventilation
Title
Rate of intraoperative hypoxemia
Description
Intraoperative hypoxemia: SpO2 ≤ 92% lasting more than 3 minutes
Time Frame
Intraoperative, period of mechanical ventilation
Title
Rate of Intraoperative bradycardia
Description
Intraoperative bradycardia: heart rate ≤ 50 bpm and the decrease of heart rate from the basic value ≥ 20% lasting more than 3 minutes
Time Frame
Intraoperative, period of mechanical ventilation
Title
Rate of LRM1 related MAP changes ≥ 10%
Description
The MAP changes between intra or 3 min after LRM1 and pre-LRM1
Time Frame
Intraoperative: during or within 3 minutes after LRM1
Title
Rate of post-anesthesia care unit respiratory failure
Description
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
Time Frame
Postoperative, during postanesthesia care unit
Title
Intraoperative mechanical power
Description
Mechanical power, J/min
Time Frame
Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Title
PaO2 / FI02
Description
PaO2 / FI02, mmHg
Time Frame
Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Other Pre-specified Outcome Measures:
Title
The first LRM1 related heart rate changes
Description
Heart rate, beat per minutes (bpm)
Time Frame
Intraoperative: pre-LRM1, during or within 3 minutes after LRM1
Title
The LRM1 related systolic blood pressure changes
Description
Systolic blood pressure, mmHg
Time Frame
Intraoperative: pre-LRM1, during or within 3 minutes after LRM1
Title
The LRM1 related diastolic blood pressure changes
Description
Diastolic blood pressure, mmHg
Time Frame
Intraoperative: pre-LRM1, during or within 3 minutes after LRM1
Title
The LRM1 related stroke volume changes
Description
Stroke volume, ml
Time Frame
Intraoperative: pre-LRM1, during or within 3 minutes after LRM1
Title
The LRM1 related cardiac output changes
Description
Cardiac output, L/min
Time Frame
Intraoperative: pre-LRM1, during or within 3 minutes after LRM1
Title
The LRM1 related stroke volume variation changes
Description
Stroke volume variation, %
Time Frame
Intraoperative: pre-LRM1, during or within 3 minutes after LRM1
Title
The LRM1 related changes of peripheral vascular resistance index
Description
Peripheral vascular resistance index, mmHg.min.L-1.m-2
Time Frame
Intraoperative: pre-LRM1, during or within 3 minutes after LRM1
Title
The first lung recruitment maneuver (LRM1) related MAP changes
Description
MAP, mmHg
Time Frame
Intraoperative: pre-LRM1, during or within 3 minutes after LRM1
Title
Dead space rate
Description
Dead space rate (%)
Time Frame
Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Li, MD
Phone
0086-020-38254070
Email
lihong36@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Nan-Rong Zhang, MD
Phone
0086-020-38254070
Email
zhangnr3@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Li, MD
Organizational Affiliation
The Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Li, Doctor
Phone
0086-020-38254070
Email
lihong36@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers
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