Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)

ARDS Clinical Trial

— EPALI  

Official title:

Preventive Strategies in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02070666
• Other study ID #: EPALI
• Status: Terminated
• Phase: N/A
• Start date: May 2014
• Est. completion date: June 2020

Study information

• Verified date: June 2020
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Behavioral:
• Protective mechanical ventilation
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
• Control group
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.

Other:
• Dead space
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.

Locations

Country	Name	City	State
Spain	Hospital de Sabadell, CSUPT	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	Mortality	In-hospital mortality, 28-day mortality and 90-day mortality	90 days
Secondary	Ventilator-free days	From 1 to 28 days over 28 days in a month	28 days after admission
Secondary	Dead space	Volumetric capnography	7 days
Secondary	Length of stay	ICU stay and hospital stay	participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks
Secondary	Pneumonia	Incidence of pneumonia	7 days
Secondary	Atelectasis	Incidence of atelectasis	7 days