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SNIFF II: Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT03129386
Collaborator
(none)
60
Enrollment
1
Location
30.8
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is investigating the normal range of maximal diaphragm thickness during a sniff inspiratory manoeuvre using ultrasound in healthy subjects stratified by age and gender.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Diaphragm dysfunction is associated with poor clinical outcomes in critically ill patients but is difficult to diagnose. Traditionally, diaphragm function is measured by evaluating inspiratory muscle strength via maximal inspiratory pressure (MIP). However, this technique relies on a volitional maximal effort and can be challenging for patients to perform.

    An alternative to measuring inspiratory muscle strength is the sniff inspiratory pressure approach. During short, sharp sniffs, the diaphragm is maximally activated.

    Currently, there are no reported values of the normal range of maximal diaphragm thickness during a sniff maneuver. This study will define the normal range of values for sniff maximal diaphragm thickening fraction, maximal thickening against an occluded airway, and diaphragm thickening during resting tidal breathing in healthy subjects.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction
    Actual Study Start Date :
    Jun 8, 2016
    Actual Primary Completion Date :
    Dec 1, 2018
    Actual Study Completion Date :
    Jan 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Sniff diaphragm thickening fraction [Day 1]

      Thickening of the diaphragm during an inspiratory sniff

    2. Maximal diaphragm thickening fraction [Day 1]

      Thickening of the diaphragm during a maximal inspiratory effort

    3. Resting tidal thickening fraction [Day 1]

      Thickening of the diaphragm during resting tidal breathing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Over 18 years of age
    Exclusion Criteria:
    • Antecedent history of neuromuscular or cardiorespiratory disease

    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, Intensivist, University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT03129386
    Other Study ID Numbers:
    • 15-8998-AE
    First Posted:
    Apr 26, 2017
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019
    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

    Study Results

    No Results Posted as of Apr 16, 2019