Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia

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

TERMINATED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-04

Study Completion Date

2023-09-21

Brief Summary

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Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia. The control strategy will be based on ARDSNet approach. The intervention group will receive a different ventilatory strategy based on positive end-expiratory pressure tailored according to compliance and limited driving pressure.

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Detailed Description

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There is no consensus on the optimal ventilatory management of patients with community-acquired pneumonia that require mechanical ventilation and have acute respiratory distress syndrome. The traditional ventilatory approach (ARDSNet) is based on a fixed table for both end respiratory positive end-expiratory pressure according to inspired oxygen fraction. Alternatively, a strategy that tailors positive end-expiratory pressure according to compliance and limits driving pressure may be beneficial, but evidence is lacking.

We will perform an open label randomized controlled trial comparing both strategies.

Conditions

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Community-acquired Pneumonia Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARDSNet strategy

Patients will receive a mechanical ventilation strategy based on fixed values of positive end-expiratory pressure according to inspired fraction of oxygen.

Plateau pressure will be limited at 30 cmH2O. This strategy will be mantained and monitored for 3 days, unless the patient dies or is extubated before.

This arm is similar to the ARMA (Ventilation with Lower Tidal Volumes as Compared with Traditional Tidal Volumes for Acute Lung Injury and the Acute Respiratory Distress Syndrome) trial.

Group Type ACTIVE_COMPARATOR

ARDSNet ventilatory strategy

Intervention Type PROCEDURE

Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.

STAMINA strategy

Patients will receive a mechanical ventilation strategy based on positive end-expiratory pressure tailored to achieve the optimal respiratory system compliance and to have driving pressure limited to 14 cmH2O.

Plateau pressure will be limited at 30 cmH2O. This strategy will be mantained and monitored for 3 days, unless the patient dies or is extubated before.

Group Type EXPERIMENTAL

Positive end-expiratory pressure titration with driving pressure control

Intervention Type PROCEDURE

Positive end-expiratory pressure will be tailored during a decremental maneuver (without a formal alveolar recruitment maneuver). The best positive end-expiratory pressure will be defined as the one associated with the higher respiratory system compliance, up to 20 cmH2O. Plateau pressure limit will be 30 cmH2O. If driving pressure remains elevated after optimal PEEP setting, tidal volume will be reduced to keep driving pressure below 14 cmH2O.

Interventions

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Positive end-expiratory pressure titration with driving pressure control

Positive end-expiratory pressure will be tailored during a decremental maneuver (without a formal alveolar recruitment maneuver). The best positive end-expiratory pressure will be defined as the one associated with the higher respiratory system compliance, up to 20 cmH2O. Plateau pressure limit will be 30 cmH2O. If driving pressure remains elevated after optimal PEEP setting, tidal volume will be reduced to keep driving pressure below 14 cmH2O.

Intervention Type PROCEDURE

ARDSNet ventilatory strategy

Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.

Intervention Type PROCEDURE

Other Intervention Names

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STAMINA

Eligibility Criteria

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Inclusion Criteria

* Patients with community acquired pneumonia requiring invasive mechanical ventilation
* Bilateral pulmonary infiltrates on chest imaging not fully explained by fluid overload in the opinion of the attending physician
* One of the criteria below:
* Oxygen inspired fraction above 50% with a positive end-expiratory pressure of at least 8 cmH2O to main peripheral oxygen saturation above 93%, OR
* Arterial partial pressure of oxygen divided by inspired fraction of oxygen lower than 200 with PEEP values of at least 5 cmH2O

* Refusal of the patient´s legal representative
* Acute neurologic disease (stroke, brain trauma, or any disease that may cause intracranial hypertension)
* Patients with current airway fistula or barotrauma
* Patients on chronic home use of oxygen due to underlying lung disease
* Patients younger than 18 years
* Patients not on full code status

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No