NCT04229810

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
732

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

January 13, 2020

Last Update Submit

January 13, 2020

Conditions

Ventilator Lung

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

STD-02

ACTIVE COMPARATOR

Conventional standardized lung protective ventilation.

Procedure: STD-02

iOLA-iHFNC

EXPERIMENTAL

Individualized ventilatory strategy that mantains an open lung condition.

Procedure: iOLA-iHFNC

Interventions

STD-02PROCEDURE

Conventional standardized ventilatory approach.

STD-02
iOLA-iHFNCPROCEDURE

Indivudualized perioperative open lung ventilatory approach.

iOLA-iHFNC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Carlos Ferrando, MD

CONTACT

+34 932275400cmferrando@clinic.cat

Sara Darriba

CONTACT

+34 932275400darriba@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgical Intensive Care Unit

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

September 15, 2020

Primary Completion

January 15, 2021

Study Completion

August 15, 2021

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share