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Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials

NCT ID: NCT06923267

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-05-31

Brief Summary

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The goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (E/E') during 3 spontaneous breathing trials in Intensive Care Unit (ICU) adults (over 18 years) patients at risk for weaning failure. The main objective is to find out which spontaneous breathing trial is the least demanding in terms of heart work.

Investigators will compare 3 consecutive spontaneous breathing trials in a random order to see if one is superior to the others.

Participants will not have to perform any specific procedure apart from breathing without respiratory support during the spontaneous breathing trial. During these trials, the investigator will perform cardiac ultrasound measurements.

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Detailed Description

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Conditions

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Weaning Invasive Mechanical Ventilation Weaning-induced Pulmonary Edema Weaning Failure of Mechanical Ventilation Spontaneous Breathing Test Intensive Care Units (ICUs)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
The ultrasound evaluator will re-read and measure cardiac indexes on anonymized loops.

Study Groups

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EVS1-EVS2-EVS3 (specific order of procedures)

EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Group Type EXPERIMENTAL

No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.

Pressure Support Spontaneous Breathing trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.

Humidified High Flow Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.

EVS1-EVS3-EVS2 (specific order of procedures)

EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Group Type EXPERIMENTAL

No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.

Pressure Support Spontaneous Breathing trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.

Humidified High Flow Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.

EVS2-EVS3-EVS1 (specific order of procedures)

EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Group Type EXPERIMENTAL

No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.

Pressure Support Spontaneous Breathing trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.

Humidified High Flow Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.

EVS2-EVS1-EVS3 (specific order of procedures)

EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Group Type EXPERIMENTAL

No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.

Pressure Support Spontaneous Breathing trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.

Humidified High Flow Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.

EVS3-EVS1-EVS2 (specific order of procedures)

EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Group Type EXPERIMENTAL

No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.

Pressure Support Spontaneous Breathing trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.

Humidified High Flow Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.

EVS3-EVS2-EVS1 (specific order of procedures)

EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Group Type EXPERIMENTAL

No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.

Pressure Support Spontaneous Breathing trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.

Humidified High Flow Spontaneous Breathing Trial

Intervention Type DIAGNOSTIC_TEST

The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.

Interventions

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No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.

Intervention Type DIAGNOSTIC_TEST

Pressure Support Spontaneous Breathing trial

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.

Intervention Type DIAGNOSTIC_TEST

Humidified High Flow Spontaneous Breathing Trial

The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial
* Richmond Agitation Sedation Scale (RASS) between -1 and +1
* Patient at high risk of re-intubation with at least one of the following criteria:

* Underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema)
* Underlying respiratory disease (COPD, Emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, restrictive lung disease)

Exclusion Criteria

* Neuromuscular pathology (myasthenia type) preceding hospitalization
* Pregnant or breast-feeding women
* Patient already included in the study
* Protected person (under guardianship or curatorship)
* Person under court protection
* Person not affiliated to a social security scheme
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Orleans

Orléans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Guillaume Fossat, Pt, Msc, PhD student

Role: CONTACT

[email protected]
+33238651318

Elodie Pougoue

Role: CONTACT

[email protected]
+33238744086

Facility Contacts

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Guillaume Fossat, Pt, Msc, PhD Student

Role: primary

[email protected]
+33238651318

Other Identifiers

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CHUO-2024-09

Identifier Type: -

Identifier Source: org_study_id

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