Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers
- Conditions
- Intraoperative Mechanical VentilationAbdominal SurgeryPostoperative Complications
- Interventions
- Other: periodic lung recruitment maneuvers
- Registration Number
- NCT05556174
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1060
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive intraoperative lung-protective ventilation periodic lung recruitment maneuvers intraoperative lung-protective ventilation with periodic lung recruitment maneuvers
- Primary Outcome Measures
Name Time Method Rate of respiratory failure 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 Outcome Measures
Name Time Method Rate of respiratory infections 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
Rate of pleural effusion 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
Rate of mild respiratory failure 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.
Rate of moderate respiratory failure 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.
Rate of sustained hypoxaemia 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.
Rate of pneumonia Day 0 to 7 after surgery Pneumonia: United States Centers for Disease Control definition of pneumonia
Rate of aspiration pneumonitis Day 0 to 7 after surgery Aspiration pneumonitis: acute lung injury after the inhalation of regurgitated gastric contents.
Rate of pneumothorax Intraoperative or day 0 to 7 after surgery Pneumothorax: air in the pleural space with no vascular bed surrounding the visceral pleura
Rate of Acute Respiratory Distress Syndrome Day 0 to 7 after surgery Acute Respiratory Distress Syndrome: The Berlin definition of Respiratory Distress Syndrome
Rate of severe respiratory failure 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.
Rate of modified respiratory failure 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.
Postoperative pulmonary complications score 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).
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) Day 0 to 7 after surgery MACCE: Stroke, coma, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure.
Rate of death Day 0 to 30 after surgery Death from any cause
Rate of intraoperative needing for vasoconstrictor Intraoperative, period of mechanical ventilation Intraoperative vasoconstrictor needs: MAP \< 60 mmHg and using any catecholamines
Intraoperative mechanical power Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation Mechanical power, J/min
Rate of Quick Sequential Organ Failure Assessment (qSOFA) ≥ 2 Day 0 to 7 after surgery 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) 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
Rate of post-anesthesia care unit respiratory failure 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 hospitalization days Day 0 to 30 after surgery The duration between the operation date and the actual discharge date, days
Rate of Unexpected admission to intensive care unit (ICU) 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.
Rate of intraoperative hypotension Intraoperative, period of mechanical ventilation Intraoperative hypotension: mean arterial pressure (MAP) \< 60 mmHg lasting more than 3 minutes
Rate of intraoperative hypoxemia Intraoperative, period of mechanical ventilation Intraoperative hypoxemia: SpO2 ≤ 92% lasting more than 3 minutes
Rate of Intraoperative bradycardia 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
PaO2 / FI02 Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation PaO2 / FI02, mmHg
Trial Locations
- Locations (1)
The Sixth Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China