Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT03447288

Conditions

ARDS

Acute Hypoxemic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Patients sedated under mechanical ventilation with acute hypoxemic respiratory failure with a PaO2/FiO2 equal or less than 200mmHg (Acute Respiratory Distress Syndrome, ARDS and non-ARDS) will be included in the study early in the course of the disease (first week of mechanical ventilation). At enrollment, data on the clinical condition of the patient will be recorded together with ventilation settings: ventilation mode, the fraction of inspired oxygen (FiO2), PEEP, tidal volume, set pressure, respiratory rate, time of the respiratory cycle, recent blood gas parameters.

Airway pressure, flow, and esophageal pressure (or alternatively electrical activity of the diaphragm, Eadi) will be recorded 3 times a day for 7 days:

1. Period 1 (morning): duration 20-30 minutes
2. Period 2 (afternoon): duration 20-30 minutes
3. Period 3 (evening / night): duration 20-30 minutes

Registration will be ended at extubation, death or at eight days from the first recording.

Monitoring of vital parameters (hemodynamic and respiratory) will be continuous throughout the duration of the study, as per normal clinical practice. All drugs used during the day of the measurements will be recorded. The patient will then be followed until discharge from the ICU and after 60 days of discharge to evaluate mortality.

As an ancillary study, in a subgroup of patients continuous simplified measurement of respiratory recordings together with hourly clinical data on sedation and extended simplified polysomnography recordings will be performed within the first 7 days from inclusion.

The analysis of the recorded waveforms will be performed in a single center by a centralized system that will quantify dyssynchrony and its intensity, calculate pressure time product, collect clinical and physiological data and outcome, and investigate possible correlations.

Conditions

ARDS

Acute Hypoxemic Respiratory Failure

Study ID

NCT03447288

Start date

Jan 15, 2017

Status verified date

Sep, 2021

Completion date

Aug, 2022

Anticipated

Primary completion date

Aug, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Moderate and severe ARDS and AHRF, according to the Berlin definition. The absence of the Chest X-Ray criterion (e.g. unilateral disease) or the presence of primary cardiac dysfunction will define AHRF.
  • Continuous intravenous sedation
  • Deep sedation: Richmond Agitation Sedation Scale (RASS) ≤ -3 or Riker Sedation-Agitation Scale (SAS) ≤ 3

Exclusion Criteria:

  • <18 years
  • Patients with a significant bronchopleural fistula
  • Pure COPD exacerbation
  • Patients on chronic home ventilation

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Prevalence of dyssynchrony [ Time Frame: Within 1 Year ]

Central Contacts and Locations

Central contacts

Locations

St Michael's hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Tài Pham, Md, PhD

647-643-2808phamo@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

Sep 30, 2021

Last verified

Sep, 2021

Keywords

  • Dyssynchrony
  • Breath-stacking
  • Asynchrony
  • Reverse Triggering
  • Mechanical Ventilation
  • Sedation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2021-09-30.