NCT03129386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

April 4, 2017

Last Update Submit

April 15, 2019

Conditions

Diaphragm

Outcome Measures

Primary Outcomes (3)

  • Sniff diaphragm thickening fraction

    Thickening of the diaphragm during an inspiratory sniff

    Day 1

  • Maximal diaphragm thickening fraction

    Thickening of the diaphragm during a maximal inspiratory effort

    Day 1

  • Resting tidal thickening fraction

    Thickening of the diaphragm during resting tidal breathing

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult subjects with no antecedent history of neuromuscular or cardiorespiratory disease.

You may qualify if:

  • Over 18 years of age

You may not qualify if:

  • Antecedent history of neuromuscular or cardiorespiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Study Officials

  • Ewan C Goligher, MD, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intensivist

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 26, 2017

Study Start

June 8, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Currently, there is no plan to make data IPD available to others.

Locations

CA(1)