Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

NCT01862016 | Unknown DMC

• 2 other identifiers: PHRC 2009-042012-A00551-42
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 1

Brief Summary

The care of acute respiratory distress syndrome (ARDS) has been significantly improved by learning from experimental and physiological research works and by a series of randomized controlled trials. The mortality of this syndrome remains however high. Numerous experimental and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the need for sedative drugs. This ventilatory mode could also reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS patients. The aim of this multicenter, prospective, randomized, controlled, open study is to compare the effects of two ventilatory strategies on the mortality of ARDS patients and placed under mechanical ventilation.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute respiratory distress syndrome; APRV ventilatory mode; Spontaneous breathing; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• all cause hospital mortality

  participants will be followed for the duration of hospital stay, until day 60 maximum.

  hospital discharge

Secondary Outcomes (15)

• all causes mortality

  Day 28

• number of days alive without mechanical ventilation

  day 28

• number of days alive without organ failure

  day 28

• number of patients with refractory hypoxemia

  day 7

• number of patients requiring adjuvant treatment of hypoxemia

  day 7

Study Arms (2)

VAC mode, Controlled ventilation

ACTIVE COMPARATOR

From randomization, patients are put under controlled ventilation with specific settings

Biological: arterial blood gas measurement each morning

APRV mode, Spontaneous breathing

EXPERIMENTAL

During 1 to 3 hours after randomization, patients are put under controlled ventilation with specific settings for baseline data. After that, they are placed under APRV mode with specific settings

Procedure: APRV; Biological: arterial blood gas measurement each morning

Interventions

APRV PROCEDURE

Pressure ventilation mode allowing early spontaneous breathing

APRV mode, Spontaneous breathing

arterial blood gas measurement each morning BIOLOGICAL

APRV mode, Spontaneous breathing; VAC mode, Controlled ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Within 1 week of a known clinical insult or new or worsening respiratory symptoms
• Intubation and mechanical ventilation
• Bilateral opacities - not fully explained by effusions, lobar/lung collapse, or nodules lung
• Report PaO2 / FiO2 ≤ 200 mmHg with a PEP of at least 5 cmH2O
• Respiratory failure not fully explained by cardiac failure or fluid overload
• Criteria 1, 2 and 3 presents jointly for less than 48 hours
• Consent to participate obtained either from the patient himself or from a relative.

You may not qualify if:

• Age \< 18 years
• Pregnancy
• Predictable duration of the mechanical ventilation on endotracheal tube lower than 48 hours
• intracranial hypertension (suspected or confirmed)
• known or suspected COPD
• Chronic respiratory failure treated by long-term oxygen and / or long-term respiratory support
• Morbid obesity defined as weight greater than 1 kg / cm
• Sickle Cell Disease
• Marrow recent transplant, post-chemotherapy aplasia
• Widened burns (\> 30% body surface area)
• Severe hepatic cirrhosis (Child-Pugh C)
• Pneumothorax (drained or not)
• Treatment with extracorporeal support (ECMO)
• Decision of active therapeutic limitation
• Unavailability of the model of respirator that must be used in the study

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Medical Intensive Care Unit, University Hospital of Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 24, 2013
• Study Start: February 28, 2013
• Primary Completion: December 16, 2017
• Study Completion: May 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

FR (1)