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Completed

NCT Number: NCT04247477

Comparison of Different PEEP Titration Strategies Using Electrical Impedance Tomography in Patients With ARDS

The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit.

Two of those strategies are based on electrical impedance tomography (EIT) monitoring.

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Key information

Conditions

ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Electrical Impedance Tomography (EIT) Lung Diseases Lung Injury Positive End Expiratory Pressure (PEEP) Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers

Angers, 49100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with moderate to severe ARDS, defined by the Berlin consensus, at 12 to 48h from diagnosis
  • PaO2/FiO2 ratio < 150 mmHg
  • Patient affiliated to or beneficiary of a health care plan
  • Consent obtained from patient's SDM

Exclusion criteria

  • Pneumothorax
  • Contraindication to the insertion of a nasogastric tube with an esophageal balloon
  • Contraindication to the use of Electrical impedance tomography
  • Pregnancy, lactating or parturient woman

Treatment and study plan

Ventilation strategy

Other

Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)

Primary outcomes

  1. Change in PaO2 (mmHg)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance!

Secondary outcomes

  1. Change in PaCO2 (mmHg)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  2. Plateau pressure (cmH2O)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  3. Positive end expiratory pressure (cmH2O)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  4. Expiratory and inspiratory transpulmonary pressure (cmH2O)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  5. Regional ventilation distribution (%)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  6. Center of ventilation (%)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  7. Overdistension and collapsus (%)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  8. Global and regional end expiratory lung impedance changes (IU)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  9. End expiratory lung volume (mL)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  10. Blood pressure (mmHg)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  11. Heart rate (bpm)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

  12. Cardiac output (L/min)

    Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

    As it is a physiological study, all the outcomes will be analyzed with the same importance

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Comparison of Different Positive End-expiratory Pressure Titration Strategies Using ELectrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome : the DELTA Physiological Study

Acronym: DELTA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2020
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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