Ventilator Lung
Conditions
Brief summary
Prospective multicenter randomized controlled trial. Individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy.
Interventions
PROCEDURESTD-02
Conventional standardized ventilatory approach.
PROCEDUREiOLA-iHFNC
Indivudualized perioperative open lung ventilatory approach.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men and women ≥18 years of age who underwent emergency laparotomy with the presence of post-induction positive air-test (SpO2 \<97% after a maximum of 15 minutes at FIO2 of 0.21). A SpO2 \<97% at any FIO2 would also be considered a positive air-test.
Exclusion criteria
* 1\) Pregnancy or breast feeding, 2) Moderate or severe ARDS defined, 3) refractory shock, 4) diagnosis or suspected intracranial hypertension (\>15mmHg), 5) mechanical ventilation in the last 15 days (including CPAP), 6) presence of pneumothorax or giant bullae in a chest radiograph or computed tomography (CT), 7) patients participating in another intervention study with the same or similar primary outcome variable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe postoperative pulmonary complications | 7 days | A composite of severe postoperative pulmonary complications appearing during the first 7 postoperative days. Postoperative pulmonary complication will include any of the following: 1) Respiratory failure, 2) Pneumothorax, 3) Weaning failure, 4) Acute respiratory distress syndrome (ARDS), 5) Pulmonary infection. |
Contacts
Primary ContactCarlos Ferrando, MD
Backup ContactSara Darriba
Outcome results
None listed