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Clinical Trials/NCT03129386
NCT03129386CompletedNot Applicable

Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction

University Health Network, Toronto2 sites in 1 country60 target enrollmentStarted: June 8, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Sniff diaphragm thickening fraction

Study Overview

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.

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
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Over 18 years of age

Exclusion Criteria

  • Antecedent history of neuromuscular or cardiorespiratory disease

Outcomes

Primary Outcomes

Sniff diaphragm thickening fraction

Time Frame: Day 1

Thickening of the diaphragm during an inspiratory sniff

Maximal diaphragm thickening fraction

Time Frame: Day 1

Thickening of the diaphragm during a maximal inspiratory effort

Resting tidal thickening fraction

Time Frame: Day 1

Thickening of the diaphragm during resting tidal breathing

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor
Principal Investigator

Ewan Goligher

Intensivist

University Health Network, Toronto

Study Sites (2)

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