Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.

Ventilator Lung Clinical Trial

Official title:

Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04229810
• Other study ID #: iPROVE-EAL
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: August 15, 2021

Study information

• Verified date: January 2020
• Source: Hospital Clinic of Barcelona
• Contact: Carlos Ferrando, MD
• Phone: +34 932275400
• Email: cmferrando[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective multicenter randomized controlled trial. Individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 732
• Est. completion date: August 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Ventilator Lung

Intervention

Procedure:
• STD-02
Conventional standardized ventilatory approach.
• iOLA-iHFNC
Indivudualized perioperative open lung ventilatory approach.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe postoperative pulmonary complications	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.	7 days