Back to resultsIndividualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.
Primary Purpose
Ventilator Lung
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
STD-02
iOLA-iHFNC
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Lung
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
STD-02
iOLA-iHFNC
Arm Description
Conventional standardized lung protective ventilation.
Individualized ventilatory strategy that mantains an open lung condition.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04229810
First Posted
January 13, 2020
Last Updated
January 13, 2020
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT04229810
Brief Title
Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.
Official Title
Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2020 (Anticipated)
Primary Completion Date
January 15, 2021 (Anticipated)
Study Completion Date
August 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective multicenter randomized controlled trial. Individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Lung
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
732 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STD-02
Arm Type
Active Comparator
Arm Description
Conventional standardized lung protective ventilation.
Arm Title
iOLA-iHFNC
Arm Type
Experimental
Arm Description
Individualized ventilatory strategy that mantains an open lung condition.
Intervention Type
Procedure
Intervention Name(s)
STD-02
Intervention Description
Conventional standardized ventilatory approach.
Intervention Type
Procedure
Intervention Name(s)
iOLA-iHFNC
Intervention Description
Indivudualized perioperative open lung ventilatory approach.
Primary Outcome Measure Information:
Title
Severe postoperative pulmonary complications
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Ferrando, MD
Phone
+34 932275400
Ext
2890
Email
cmferrando@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Darriba
Phone
+34 932275400
Ext
2890
Email
darriba@clinic.cat
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.
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