The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
NCT Number: NCT05556174
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510655, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
lung recruitment maneuvers repeated every 30 minutes
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
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.
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.
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.
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.
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.
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
Time frame: Day 0 to 7 after surgery
Pneumonia: United States Centers for Disease Control definition of pneumonia
Time frame: Day 0 to 7 after surgery
Aspiration pneumonitis: acute lung injury after the inhalation of regurgitated gastric contents.
Time frame: Intraoperative or day 0 to 7 after surgery
Pneumothorax: air in the pleural space with no vascular bed surrounding the visceral pleura
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
Time frame: Day 0 to 7 after surgery
Acute Respiratory Distress Syndrome: The Berlin definition of Respiratory Distress Syndrome
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
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
Time frame: Day 0 to 7 after surgery
MACCE: Stroke, coma, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure.
Time frame: Day 0 to 30 after surgery
The duration between the operation date and the actual discharge date, days
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.
Time frame: Day 0 to 30 after surgery
Death from any cause
Time frame: Intraoperative, period of mechanical ventilation
Intraoperative hypotension: mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes
Time frame: Intraoperative, period of mechanical ventilation
Intraoperative vasoconstrictor needs: MAP < 60 mmHg and using any catecholamines
Time frame: Intraoperative, period of mechanical ventilation
Intraoperative hypoxemia: SpO2 ≤ 92% lasting more than 3 minutes
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
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
Time frame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Mechanical power, J/min
Time frame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
PaO2 / FI02, mmHg
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).
Time frame: Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation
Dead space rate (%)
Sixth Affiliated Hospital, Sun Yat-sen University
Other
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
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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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