NCT02070666

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

6.1 years

First QC Date

February 19, 2014

Last Update Submit

June 17, 2020

Conditions

ARDS

Keywords

ARDSPreventionProtective mechanical ventilationlow tidal volumes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Mortality

    90 days

  • Ventilator-free days

    28 days after admission

  • Dead space

    7 days

  • Length of stay

    participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks

  • Pneumonia

    7 days

  • +1 more secondary outcomes

Study Arms (2)

Protective ventilation arm

EXPERIMENTAL

* 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.

Behavioral: Protective mechanical ventilationOther: Dead space

Control group

ACTIVE COMPARATOR

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

Behavioral: Control groupOther: Dead space

Interventions

Protective mechanical ventilationBEHAVIORAL

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

Protective ventilation arm
Control groupBEHAVIORAL

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.

Control group
Dead spaceOTHER

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 groupProtective ventilation arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LIPS \> 4 points.
  • Absence of mild, moderate and severe ARDS criteria (Berlin definition).
  • Older than 18 year-old.
  • Signed informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Sabadell, CSUPT

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

  • 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.

    PMID: 37351068DERIVED

MeSH Terms

Interventions

Control GroupsRespiratory Dead Space

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Critical Care Arrea

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 25, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 19, 2020

Record last verified: 2020-06

Locations

ES(1)