Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction

Diaphragm Clinical Trial

— SNIFF II  

Official title:

Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129386
• Other study ID #: 15-8998-AE
• Status: Completed
• Start date: June 8, 2016
• Est. completion date: January 2019

Study information

• Verified date: April 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age

Exclusion Criteria:

• Antecedent history of neuromuscular or cardiorespiratory disease

Related Conditions & MeSH terms

• Diaphragm

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sniff diaphragm thickening fraction	Thickening of the diaphragm during an inspiratory sniff	Day 1
Primary	Maximal diaphragm thickening fraction	Thickening of the diaphragm during a maximal inspiratory effort	Day 1
Primary	Resting tidal thickening fraction	Thickening of the diaphragm during resting tidal breathing	Day 1