Postoperative ComplicationsREMAIN-1NCT05556174
Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers
A study testing periodic lung recruitment maneuvers in people with Postoperative Complications and Abdominal Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Abdominal Surgery, Intraoperative Mechanical Ventilation
- What is being tested?
- periodic lung recruitment maneuvers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,060 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2022to 11 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
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
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.
- Being tested
- periodic lung recruitment maneuvers
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodic lung recruitment maneuversOther
lung recruitment maneuvers repeated every 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intensive intraoperative lung-protective ventilation | Experimental | intraoperative lung-protective ventilation with periodic lung recruitment maneuvers Receives: Other: periodic lung recruitment maneuvers |
| Moderate intraoperative lung-protective ventilation | No intervention | intraoperative lung-protective ventilation without periodic lung recruitment maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 to 7 after surgery
Secondary outcomes (25)
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.
Measured: Day 0 to 7 after surgery
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.
Measured: Day 0 to 7 after surgery
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.
Measured: Day 0 to 7 after surgery
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.
Measured: Day 0 to 7 after surgery
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.
Measured: Day 0 to 7 after surgery
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
Measured: Day 0 to 7 after surgery
Rate of pneumonia
Pneumonia: United States Centers for Disease Control definition of pneumonia
Measured: Day 0 to 7 after surgery
Rate of aspiration pneumonitis
Aspiration pneumonitis: acute lung injury after the inhalation of regurgitated gastric contents.
Measured: Day 0 to 7 after surgery
Rate of pneumothorax
Pneumothorax: air in the pleural space with no vascular bed surrounding the visceral pleura
Measured: Intraoperative or day 0 to 7 after surgery
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
Measured: Day 0 to 7 after surgery
Rate of Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome: The Berlin definition of Respiratory Distress Syndrome
Measured: Day 0 to 7 after surgery
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
Measured: Day 0 to 7 after surgery
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
Measured: Day 0 to 7 after surgery
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE: Stroke, coma, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure.
Measured: Day 0 to 7 after surgery
Postoperative hospitalization days
The duration between the operation date and the actual discharge date, days
Measured: Day 0 to 30 after surgery
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.
Measured: Day 0 to 30 after surgery
Rate of death
Death from any cause
Measured: Day 0 to 30 after surgery
Rate of intraoperative hypotension
Intraoperative hypotension: mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes
Measured: Intraoperative, period of mechanical ventilation
Rate of intraoperative needing for vasoconstrictor
Intraoperative vasoconstrictor needs: MAP < 60 mmHg and using any catecholamines
Measured: Intraoperative, period of mechanical ventilation
Rate of intraoperative hypoxemia
Intraoperative hypoxemia: SpO2 ≤ 92% lasting more than 3 minutes
Measured: Intraoperative, period of mechanical ventilation
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
Measured: Intraoperative, period of mechanical ventilation
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
Measured: Postoperative, during postanesthesia care unit
Intraoperative mechanical power
Mechanical power, J/min
Measured: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
PaO2 / FI02
PaO2 / FI02, mmHg
Measured: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Postoperative pulmonary complications score
Postoperative pulmonary complications score: graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications).
Measured: Day 0 to 7 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start9 Oct 2022
- Primary completion11 Sep 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,060 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Li, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556174
- Sponsor's protocol ID
- 2022ZSLYEC-398
- Acronym
- REMAIN-1
- Status last verified
- Nov 2024
- First submitted
- 14 Sep 2022
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40082005
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05556174
- Acronym / sponsor ID
- REMAIN-1 / 2022ZSLYEC-398
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,060 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 9 Oct 2022 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive intraoperative lung-protective ventilation | Experimental | Other: periodic lung recruitment maneuversintraoperative lung-protective ventilation with periodic lung recruitment maneuvers |
| Moderate intraoperative lung-protective ventilation | No intervention | –intraoperative lung-protective ventilation without periodic lung recruitment maneuvers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodic lung recruitment maneuverslung recruitment maneuvers repeated every 30 minutes | Other | Intensive intraoperative lung-protective ventilation |
Primary outcome
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
25 secondary outcomes
Rate of mild respiratory failure
Time frame: Day 0 to 7 after surgery
Rate of moderate respiratory failure
Time frame: Day 0 to 7 after surgery
Rate of severe respiratory failure
Time frame: Day 0 to 7 after surgery
Rate of sustained hypoxaemia
Time frame: Day 0 to 7 after surgery
Rate of modified respiratory failure
Time frame: Day 0 to 7 after surgery
Rate of respiratory infections
Time frame: Day 0 to 7 after surgery
Rate of pneumonia
Time frame: Day 0 to 7 after surgery
Rate of aspiration pneumonitis
Time frame: Day 0 to 7 after surgery
Rate of pneumothorax
Time frame: Intraoperative or day 0 to 7 after surgery
Rate of pleural effusion
Time frame: Day 0 to 7 after surgery
Rate of Acute Respiratory Distress Syndrome
Time frame: Day 0 to 7 after surgery
Rate of Quick Sequential Organ Failure Assessment (qSOFA) ≥ 2
Time frame: Day 0 to 7 after surgery
Rate of Systemic Inflammatory Response Syndrome (SIRS)
Time frame: Day 0 to 7 after surgery
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: Day 0 to 7 after surgery
Postoperative hospitalization days
Time frame: Day 0 to 30 after surgery
Rate of Unexpected admission to intensive care unit (ICU)
Time frame: Day 0 to 30 after surgery
Rate of death
Time frame: Day 0 to 30 after surgery
Rate of intraoperative hypotension
Time frame: Intraoperative, period of mechanical ventilation
Rate of intraoperative needing for vasoconstrictor
Time frame: Intraoperative, period of mechanical ventilation
Rate of intraoperative hypoxemia
Time frame: Intraoperative, period of mechanical ventilation
Rate of Intraoperative bradycardia
Time frame: Intraoperative, period of mechanical ventilation
Rate of post-anesthesia care unit respiratory failure
Time frame: Postoperative, during postanesthesia care unit
Intraoperative mechanical power
Time frame: 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
Postoperative pulmonary complications score
Time frame: Day 0 to 7 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Derived from this study: PubMed 40082005Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Li, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodic lung recruitment maneuvers in people with Postoperative Complications and Abdominal Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of respiratory failure (time frame: Day 0 to 7 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05556174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.