NCT04041817

Brief Summary

Pressure support ventilation allows intubated ICU patients to breathe spontaneously. Among specific settings, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. The trigger threshold corresponds to the sensitivity of the ventilator to detect patient's inspiratory effort and then deliver the predefined pressure support to inflate the lungs and deliver a tidal volume. The purpose of this study is to explore the influence of trigger level on pulmonary and ventilatory physio (-patho)logical parameters in spontaneously breathing ICU patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 3, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

3.8 years

First QC Date

July 25, 2019

Last Update Submit

February 16, 2023

Conditions

ICU PatientsIntubationSpontaneously BreathingPulmonary FunctionTracheotomy

Keywords

ICUPressure support ventilationSpontaneous breathingTriggerWeaning of mechanical ventilation

Outcome Measures

Primary Outcomes (11)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T0 (before the first trigger step)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T15 minutes (last minute of the trigger step n°1)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T30 minutes (last minute of the trigger step n°2)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T45 minutes (last minute of the trigger step n°3)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T60 minutes (last minute of the trigger step n°4)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T75 minutes (last minute of the trigger step n°5)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T90 minutes (last minute of the trigger step n°6)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T105 minutes (last minute of the trigger step n°7)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T120 minutes (last minute of the trigger step n°8)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T135 minutes (last minute of the trigger step n°9)

  • Lung volume (end expiratory lung volume, EELV) at each trigger level

    The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol

    T150 minutes (last minute of the trigger step n°10)

Secondary Outcomes (14)

  • Homogeneity of pulmonary aeration

    Through study completion, 150 minutes

  • Homogeneity of pulmonary aeration

    Through study completion, 150 minutes

  • Regional impedance variation

    Through study completion, 150 minutes

  • Atelectrauma

    Through study completion, 150 minutes

  • Lung volume variations

    Through study completion, 150 minutes

  • +9 more secondary outcomes

Study Arms (1)

Trigger increasing steps

EXPERIMENTAL

Trigger variations will be performed following increasing steps of 2 L/min every 15 minutes. End expiratory lung volume and lung aeration will be conducted using elecrical impedance tomography. Diaphragmatic motion and thickening will be analyzed by ultrasonography. Work of breathing will be evaluated using gastric and oesophageal pressure measurements. Measurements will be conducted during the last minute of each step.

Other: Trigger setting of pressure support ventilation

Interventions

Trigger setting of pressure support ventilationOTHER

Trigger variations will be performed following increasing steps of 3 L/min every 15 minutes, from 0.2 to 15 L/min (0.2 - 3 - 6 - 9 - 12 - 15).

Trigger increasing steps

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Patient hospitalized in the Intensive Care Unit of Clermont-Ferrand's Hospital
  • Patients with mechanical invasive ventilation in spontaneous ventilation with inspiratory support (intubation or tracheostomy)
  • Trigger level set to minimum

You may not qualify if:

  • Refusal to participate in the proposed study
  • Contraindication to the installation of a nasogastric tube:
  • Severe disorder of uncorrected blood clotting
  • Known nasosinus lesion
  • Oesophageal varices recently ligated (\<48h)
  • Contraindication to the use of the electro-impedancemetry technique by tomography
  • Thoracic lesions
  • Chest dressings
  • Pace-maker / Implantable Defibrillator
  • Known lesion of central respiratory centers, including patients with neurological injury
  • Patients with Acute Respiratory Distress Syndrome (according to Berlin criteria)
  • Patients with restrictive or obstructive pulmonary pathology
  • Patients admitted post-operatively for surgery that may affect the diaphragmatic function ( thoracic or abdominal supra-mesocolic)
  • Patients with abdominal distention (ileus, intra-abdominal hyperpressure)
  • Patient whose BMI is greater than 35 kg.m-2
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation Adultes et Soins Continus

Clermont-Ferrand, 63000, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Statistical analysis will be conducted by an independant statistician not involved in data collection
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2019

First Posted

August 1, 2019

Study Start

April 3, 2019

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

FR(1)