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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

732 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-08-15

Brief Summary

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

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Detailed Description

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Conditions

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Ventilator Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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STD-02

Conventional standardized lung protective ventilation.

Group Type ACTIVE_COMPARATOR

STD-02

Intervention Type PROCEDURE

Conventional standardized ventilatory approach.

iOLA-iHFNC

Individualized ventilatory strategy that mantains an open lung condition.

Group Type EXPERIMENTAL

iOLA-iHFNC

Intervention Type PROCEDURE

Indivudualized perioperative open lung ventilatory approach.

Interventions

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STD-02

Conventional standardized ventilatory approach.

Intervention Type PROCEDURE

iOLA-iHFNC

Indivudualized perioperative open lung ventilatory approach.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No