Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers (REMAIN-1)

January 2, 2025 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

Intraoperative Lung Protective Ventilation With or Without Periodic Lung Recruitment Maneuvers on Pulmonary Complications After Major Abdominal Surgery: a Prospective Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1060

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intensive intraoperative lung-protective ventilation
intraoperative lung-protective ventilation with periodic lung recruitment maneuvers
Other: periodic lung recruitment maneuvers
lung recruitment maneuvers repeated every 30 minutes
No Intervention: Moderate intraoperative lung-protective ventilation
intraoperative lung-protective ventilation without periodic lung recruitment maneuvers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of respiratory failure
Time Frame: Day 0 to 7 after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of mild respiratory failure
Time Frame: Day 0 to 7 after surgery
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
Rate of moderate respiratory failure
Time Frame: Day 0 to 7 after surgery
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
Rate of severe respiratory failure
Time Frame: Day 0 to 7 after surgery
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
Rate of sustained hypoxaemia
Time Frame: Day 0 to 7 after surgery
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.
Day 0 to 7 after surgery
Rate of modified respiratory failure
Time Frame: Day 0 to 7 after surgery
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
Rate of respiratory infections
Time Frame: Day 0 to 7 after surgery
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
Rate of pneumonia
Time Frame: Day 0 to 7 after surgery
Pneumonia: United States Centers for Disease Control definition of pneumonia
Day 0 to 7 after surgery
Rate of aspiration pneumonitis
Time Frame: Day 0 to 7 after surgery
Aspiration pneumonitis: acute lung injury after the inhalation of regurgitated gastric contents.
Day 0 to 7 after surgery
Rate of pneumothorax
Time Frame: Intraoperative or day 0 to 7 after surgery
Pneumothorax: air in the pleural space with no vascular bed surrounding the visceral pleura
Intraoperative or day 0 to 7 after surgery
Rate of pleural effusion
Time Frame: Day 0 to 7 after surgery
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
Rate of Acute Respiratory Distress Syndrome
Time Frame: Day 0 to 7 after surgery
Acute Respiratory Distress Syndrome: The Berlin definition of Respiratory Distress Syndrome
Day 0 to 7 after surgery
Rate of Quick Sequential Organ Failure Assessment (qSOFA) ≥ 2
Time Frame: Day 0 to 7 after surgery
qSOFA ≥ 2: Two or more of: Respiratory rate ≥22/min, Altered mentation, Systolic blood pressure ≤ 100 mm Hg
Day 0 to 7 after surgery
Rate of Systemic Inflammatory Response Syndrome (SIRS)
Time Frame: Day 0 to 7 after surgery
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
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time Frame: Day 0 to 7 after surgery
MACCE: Stroke, coma, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure.
Day 0 to 7 after surgery
Postoperative hospitalization days
Time Frame: Day 0 to 30 after surgery
The duration between the operation date and the actual discharge date, days
Day 0 to 30 after surgery
Rate of Unexpected admission to intensive care unit (ICU)
Time Frame: Day 0 to 30 after surgery
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
Rate of death
Time Frame: Day 0 to 30 after surgery
Death from any cause
Day 0 to 30 after surgery
Rate of intraoperative hypotension
Time Frame: Intraoperative, period of mechanical ventilation
Intraoperative hypotension: mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes
Intraoperative, period of mechanical ventilation
Rate of intraoperative needing for vasoconstrictor
Time Frame: Intraoperative, period of mechanical ventilation
Intraoperative vasoconstrictor needs: MAP < 60 mmHg and using any catecholamines
Intraoperative, period of mechanical ventilation
Rate of intraoperative hypoxemia
Time Frame: Intraoperative, period of mechanical ventilation
Intraoperative hypoxemia: SpO2 ≤ 92% lasting more than 3 minutes
Intraoperative, period of mechanical ventilation
Rate of Intraoperative bradycardia
Time Frame: Intraoperative, period of mechanical ventilation
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
Rate of post-anesthesia care unit respiratory failure
Time Frame: Postoperative, during postanesthesia care unit
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
Intraoperative mechanical power
Time Frame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Mechanical power, J/min
Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
PaO2 / FI02
Time Frame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
PaO2 / FI02, mmHg
Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Postoperative pulmonary complications score
Time Frame: Day 0 to 7 after surgery
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dead space rate
Time Frame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Dead space rate (%)
Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hong Li, MD, The Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022ZSLYEC-398

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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