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Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS) (EPALI)

Primary Purpose

ARDS

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Protective mechanical ventilation
Control group
Dead space
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ARDS focused on measuring ARDS, Prevention, Protective mechanical ventilation, low tidal volumes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients within 12 hours after start of invasive mechanical ventilation (MV) and admitted to participating ICU (it is recommended an inclusion as soon as possible during the first 3 hours).
  • LIPS > 4 points.
  • Absence of mild, moderate and severe ARDS criteria (Berlin definition).
  • Older than 18 year-old.
  • Signed informed consent

Exclusion Criteria:

  • Bilateral pulmonary infiltrates in chest X-ray at admission.
  • Mechanical ventilation > 12 hours.
  • Previous pneumonectomy or lobectomy.
  • Severe cranial trauma (Glasgow Coma Scale<9) or cranial hypertension.
  • Severe chronic pulmonary disease (GOLD IV).
  • Admission from other hospital under MV.
  • Limitation of therapeutic effort.
  • Pregnancy.
  • Acute pulmonary embolism.
  • Participation in other interventional trials.
  • Previous randomized in the proposed trial.
  • Absence of informed consent.

Sites / Locations

  • Hospital de Sabadell, CSUPT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Protective ventilation arm

Control group

Arm Description

Low tidal volumes (from 4 to 6 milliliters(mL)/kilogram (kg) of predicted body weight (PBW) Plateau pressure less than 25 centimeter of water (cmH2O) Minimum PEEP of 5 cmH2O.

Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW) Plateau pressure less than 25 cmH2O Minimum PEEP of 5 cmH2O.

Outcomes

Primary Outcome Measures

ARDS development
To determine the effect of a protective mechanical ventilation strategy using lower tidal volumes as compared to mechanical ventilation using traditionally-sized tidal volumes on development of ARDS.

Secondary Outcome Measures

Mortality
In-hospital mortality, 28-day mortality and 90-day mortality
Ventilator-free days
From 1 to 28 days over 28 days in a month
Dead space
Volumetric capnography
Length of stay
ICU stay and hospital stay
Pneumonia
Incidence of pneumonia
Atelectasis
Incidence of atelectasis

Full Information

First Posted
February 19, 2014
Last Updated
June 17, 2020
Sponsor
Corporacion Parc Tauli
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1. Study Identification

Unique Protocol Identification Number
NCT02070666
Brief Title
Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)
Acronym
EPALI
Official Title
Preventive Strategies in Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment and published data with no benefit
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury Prediction Score), under mechanical ventilation could benefit from a protective ventilatory strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This would lead to a decrease in incidence, mortality and health care costs associated to this syndrome. This study will help to confirm the current evidence about low tidal volumes, evaluating adverse events of this strategy.
Detailed Description
The main objective is to evaluate the effect of a protective ventilatory strategy by using lower tidal volumes compared to the use of traditionally volumes in ARDS development.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS
Keywords
ARDS, Prevention, Protective mechanical ventilation, low tidal volumes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protective ventilation arm
Arm Type
Experimental
Arm Description
Low tidal volumes (from 4 to 6 milliliters(mL)/kilogram (kg) of predicted body weight (PBW) Plateau pressure less than 25 centimeter of water (cmH2O) Minimum PEEP of 5 cmH2O.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW) Plateau pressure less than 25 cmH2O Minimum PEEP of 5 cmH2O.
Intervention Type
Behavioral
Intervention Name(s)
Protective mechanical ventilation
Intervention Description
Ventilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode; a minimum of 5 cmH2O level of support should be used; in case the resulting tidal volume exceeds 6 mL/kg PBW this is accepted. This is not a reason to use more sedation and/or muscle relaxants, or to switch the ventilator to a controlled mode of ventilation). Tidal volume: 6 mL/Kg PBW, decreasing 1 mL/kg PBW each step if necessary (steps of 5 minutes), to maintain plateau pressure < 25 cmH2O until a minimum tidal volume of 4 mL/Kg PBW, unless the patient suffers from severe dyspnea or unacceptable acidosis. Fraction of inspired oxygen inspired oxygen fraction (FiO2) > 0.21 to maintain oxygen saturation 90-92%. PEEP ≥ 5 cmH2O, and optimized to maintain Oxygen saturation (SpO2) 90-92% (left to the discretion of the attending physician). Plateau pressure ≤ 25 cmH2O
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Ventilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode, with the level of support adjusted to reach tidal volumes minimum of 8 mL/kg predicted body weight PBW; if it is not possible, the data collection should be continue and an intention-to-treat analysis will be done). Tidal volume: minimum 8 mL/kg PBW. It is possible to increase until 10 mL/kg PBW unless plateau pressure increases above 25 cmH2O. · FiO2 > 0.21 to maintain oxygen saturation 90-92%. PEEP ≥ 5 cmH2O, and optimized to maintain SpO2 90-92% (left to the discretion of the attending physician). Plateau pressure ≤ 25 cm H2O.
Intervention Type
Other
Intervention Name(s)
Dead space
Intervention Description
Volumetric capnography will be used. Dead space (Vd/Vt) measurements will be taken at baseline and daily after initiation of mechanical ventilation. Nursing and respiratory care activities (including changes to ventilator settings) will be suspended for at least 5 minutes prior to all Vd/Vt measurements.
Primary Outcome Measure Information:
Title
ARDS development
Description
To determine the effect of a protective mechanical ventilation strategy using lower tidal volumes as compared to mechanical ventilation using traditionally-sized tidal volumes on development of ARDS.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Mortality
Description
In-hospital mortality, 28-day mortality and 90-day mortality
Time Frame
90 days
Title
Ventilator-free days
Description
From 1 to 28 days over 28 days in a month
Time Frame
28 days after admission
Title
Dead space
Description
Volumetric capnography
Time Frame
7 days
Title
Length of stay
Description
ICU stay and hospital stay
Time Frame
participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks
Title
Pneumonia
Description
Incidence of pneumonia
Time Frame
7 days
Title
Atelectasis
Description
Incidence of atelectasis
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients within 12 hours after start of invasive mechanical ventilation (MV) and admitted to participating ICU (it is recommended an inclusion as soon as possible during the first 3 hours). LIPS > 4 points. Absence of mild, moderate and severe ARDS criteria (Berlin definition). Older than 18 year-old. Signed informed consent Exclusion Criteria: Bilateral pulmonary infiltrates in chest X-ray at admission. Mechanical ventilation > 12 hours. Previous pneumonectomy or lobectomy. Severe cranial trauma (Glasgow Coma Scale<9) or cranial hypertension. Severe chronic pulmonary disease (GOLD IV). Admission from other hospital under MV. Limitation of therapeutic effort. Pregnancy. Acute pulmonary embolism. Participation in other interventional trials. Previous randomized in the proposed trial. Absence of informed consent.
Facility Information:
Facility Name
Hospital de Sabadell, CSUPT
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

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Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)

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