The PROtective Ventilation Using Open Lung Approach Or Not Trial

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · May 17, 2017

Keywords

ClinConnect Summary

1. Sample size calculation, randomization and patients safety. The required sample size is calculated from previous studies on the incidence of postoperative pulmonary complications. A two group chi-square test with a 0.05 two-sided significance level will have 80% power to detect the difference (in primary outcome) between conventional mechanical ventilation strategy (25%) and open lung approach mechanical ventilation strategy (12.5%) when the sample size in each group is 126. In consideration of a 10% loss rate, 280 cases to be included in this trial.

Research will be carried out in t...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 40 years.
• • 2. Undergo elective laparoscopic resection of colorectal cancer.
• • 3. With an expected duration of pneumoperitoneum ≥1.5h.
• • 4. With a preoperative risk index for pulmonary complications ≥ 2.
• • 5. With no contraindication of epidural anesthesia.
• • 6. Pulse oxygen saturation in air ≥ 92%.
• • 7. And informed consent obtained.
• Exclusion Criteria:
• • 1. American Society of Anesthesiologists (ASA) physical status ≥ IV.
• • 2. Body mass index ≥30kg/m2.
• • 3. Duration of mechanical ventilation ≥ 1h within 2 weeks preceding surgery.
• • 4. A history of acute respiratory failure within 1 month preceding surgery.
• • 5. With a sepsis or septic shock or instable hemodynamics.
• • 6. With a progressive neuromuscular illness such as myasthenia gravis.
• • 7. With a epilepsy or schizophrenia or Parkinson's disease.
• • 8. With a severe chronic obstructive pulmonary disease (COPD) or pulmonary bulla.
• • 9. Severe organ dysfunction (acute coronary syndrome, uremia, hepatic encephalopathy, classification of function capacity of the NYHA ≥III, malignant arrhythmia and so on).
• • 10. Coma, severe cognitive deficit, language or hearing impairment who cannot communicate.
• • 11. Not proper controlled hypertension.
• • 12. Involved in other clinical studies or refused to join in the research.