Abdominal Surgery, Intraoperative Mechanical Ventilation, Postoperative Complications
Conditions
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.
Interventions
OTHERperiodic lung recruitment maneuvers
lung recruitment maneuvers repeated every 30 minutes
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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 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 Acute Respiratory Distress Syndrome | Day 0 to 7 after surgery | Acute Respiratory Distress Syndrome: The Berlin definition of Respiratory Distress Syndrome |
| 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 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. |
| 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 death | Day 0 to 30 after surgery | Death from any cause |
| 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 needing for vasoconstrictor | Intraoperative, period of mechanical ventilation | Intraoperative vasoconstrictor needs: MAP \< 60 mmHg and using any catecholamines |
| 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 |
| 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 |
| Intraoperative mechanical power | Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation | Mechanical power, J/min |
| PaO2 / FI02 | Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation | PaO2 / FI02, mmHg |
| 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dead space rate | Intraoperative: after half an hour of mechanical ventilation, before the end of mechanical ventilation | Dead space rate (%) |
Countries
China
Outcome results
None listed