Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)

NCT ID: NCT02070666

Last Updated: 2020-06-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-06-30

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.

Conditions

ARDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Protective ventilation arm

• 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.

Group Type: EXPERIMENTAL

Protective mechanical ventilation

Intervention Type: BEHAVIORAL

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

Dead space

Intervention Type: OTHER

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.

Control group

Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW)

• Plateau pressure less than 25 cmH2O
• Minimum PEEP of 5 cmH2O.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: BEHAVIORAL

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.

Dead space

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Antonio Artigas Raventós

Director of Critical Care Arrea

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital de Sabadell, CSUPT

Sabadell, Barcelona, Spain

Countries

Spain

References

de Haro C, Neto AS, Goma G, Gonzalez ME, Ortega A, Forteza C, Frutos-Vivar F, Garcia R, Simonis FD, Gordo-Vidal F, Suarez D, Schultz MJ, Artigas A. Effect of a low versus intermediate tidal volume strategy on pulmonary complications in patients at risk of acute respiratory distress syndrome-a randomized clinical trial. Front Med (Lausanne). 2023 Jun 7;10:1172434. doi: 10.3389/fmed.2023.1172434. eCollection 2023.

Reference Type: DERIVED

PMID: 37351068 (View on PubMed)

Other Identifiers

EPALI

Identifier Type: -

Identifier Source: org_study_id