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SNIFF III: The Validity of Maximal Diaphragm Thickening Fraction to Measure Diaphragm Function in Mechanically Ventilated Patients

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT03129217
Collaborator
(none)
29
Enrollment
1
Location
53
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to determine whether maximal diaphragm thickening fraction measured by ultrasound during volitional maximal inspiratory efforts is a valid measure of diaphragm function in mechanically ventilated patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Classically, assessing diaphragm function requires direct measurements of transdaphragmatic pressure generation. A critical requirement for valid measurements is a maximal volitional patient effort. An alternative is to standardize the stimulus to the diaphragm using magnetic twitch stimulation fo the phrenic nerve. This is the gold standard technique for diaphragm function measurement in the respiratory physiology laboratory.

    Twitch measurements require technical expertise and expensive equipment; this technique is therefore basically limited to the laboratory. Bedside ultrasonography has been proposed as a method for measuring diaphragm function by assessing the thickening of the muscle during a maximal inspiratory effort. In order to achieve a maximal volitional effort in mechanically ventilated patients, several methods may be employed: coached maximal efforts, coached sniffing, and transient airway occlusion to stimulate respiratory drive (Marini maneuver).

    The investigators are evaluating the validity of diaphragm functional assessment using bedside ultrasound in combination with coached efforts/sniffing/Marini maneuver against the gold standard technique: twitch transdiaphragmatic pressure.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    29 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Validity of Maximal Diaphragm Thickening Fraction to Measure Diaphragm Function in Mechanically Ventilated Patients
    Actual Study Start Date :
    Nov 1, 2015
    Actual Primary Completion Date :
    Apr 1, 2020
    Actual Study Completion Date :
    Apr 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Patients weaning from mechanical ventilation

    Outcome Measures

    Primary Outcome Measures

    1. Maximal diaphragm thickening fraction [On day of study]

      Diaphragm ultrasound to measure thickening fraction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult patients (≥ 18 years old) with acute respiratory failure receiving invasive mechanical ventilation via endotracheal tube or tracheostomy

    • Patients who meet readiness-to-wean criteria (triggering the ventilator; FiO2 ≤ 50%; PEEP ≤ 8 cm H20; hemodynamic stability)

    Exclusion Criteria:

    • Contraindication to phrenic nerve stimulation (chest tube; cardiac pacemaker or implanted defibrillator; cervical implants; use of neuromuscular blocking agents within the 24 hours preceding the first diaphragm assessment (with the exception of succinylcholine used during rapid-sequence induction of anaesthesia for intubation); cervical spine injury; known pregnancy)

    • Patients experiencing an acute exacerbation of an obstructive lung disease (chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada M5G 2N2

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Ewan C Goligher, MD, PhD, University Health Network, Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ewan Goligher, Clinical Associate, University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT03129217
    Other Study ID Numbers:
    • 15-9644-AE
    First Posted:
    Apr 26, 2017
    Last Update Posted:
    Aug 21, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ewan Goligher, Clinical Associate, University Health Network, Toronto
    Diaphragm function
    Acute respiratory failure
    Weaning

    Study Results

    No Results Posted as of Aug 21, 2020