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Completed

NCT Number: NCT05556174

Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

periodic lung recruitment maneuvers

Other

lung recruitment maneuvers repeated every 30 minutes

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. Rate of pneumonia

    Time frame: Day 0 to 7 after surgery

    Pneumonia: United States Centers for Disease Control definition of pneumonia

  8. Rate of aspiration pneumonitis

    Time frame: Day 0 to 7 after surgery

    Aspiration pneumonitis: acute lung injury after the inhalation of regurgitated gastric contents.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  15. Postoperative hospitalization days

    Time frame: Day 0 to 30 after surgery

    The duration between the operation date and the actual discharge date, days

  16. 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.

  17. Rate of death

    Time frame: Day 0 to 30 after surgery

    Death from any cause

  18. Rate of intraoperative hypotension

    Time frame: Intraoperative, period of mechanical ventilation

    Intraoperative hypotension: mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes

  19. Rate of intraoperative needing for vasoconstrictor

    Time frame: Intraoperative, period of mechanical ventilation

    Intraoperative vasoconstrictor needs: MAP < 60 mmHg and using any catecholamines

  20. Rate of intraoperative hypoxemia

    Time frame: Intraoperative, period of mechanical ventilation

    Intraoperative hypoxemia: SpO2 ≤ 92% lasting more than 3 minutes

  21. 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

  22. 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

  23. Intraoperative mechanical power

    Time frame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation

    Mechanical power, J/min

  24. PaO2 / FI02

    Time frame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation

    PaO2 / FI02, mmHg

  25. 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).

Other outcomes

  1. Dead space rate

    Time frame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation

    Dead space rate (%)

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: REMAIN-1

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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