NCT02617394

Brief Summary

Occasionally, doctors need to be able to see whether the diaphragm - a muscle in the chest that helps control breathing - is moving properly. If the diaphragm is paralyzed or not moving properly, this can affect a person's breathing. After certain nerve blocks - where a part of the body is frozen using local anesthetic - the nerve controlling diaphragm movement can be anesthetized, causing diaphragm paralysis. Ultrasound can be used to see the diaphragm and measure its movement, but the easiest and fastest way to do this is debatable. The investigators wish to compare two ultrasound-based methods to image diaphragm movement to see which one offers the quickest and easiest way to determine if the diaphragm is paralyzed.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

November 24, 2015

Last Update Submit

March 23, 2020

Conditions

Respiratory Diaphragm

Outcome Measures

Primary Outcomes (1)

  • Time taken to image diaphragm

    Total time will be from when the probe is placed on the patient's body to when a good quality image of the diaphragm is recorded. This will be done on each side of the body.

    Approximately 2-5 minutes from start of ultrasound scan

Study Arms (2)

Control group

ACTIVE COMPARATOR
Other: Diaphragm scanning - traditional method first

Study group

EXPERIMENTAL
Other: Diaphragm scanning - novel method first

Interventions

Diaphragm scanning - traditional method firstOTHER

The first (pre-block) diaphragm scan with ultrasound will be done on both sides using the liver (right side) and spleen (left side) as acoustic windows. The second (post-block) diaphragm scan will be done on both sides using a novel method in which lung sliding is used as a guide to identify the diaphragm and quantify diaphragm thickening upon respiration.

Control group
Diaphragm scanning - novel method firstOTHER

The first (pre-block) diaphragm scan with ultrasound will be done on both sides using a novel method in which lung sliding is used as a guide to identify the diaphragm and quantify diaphragm thickening upon respiration. The second (post-block) diaphragm scan will be done will be done on both sides using the liver (right side) and spleen (left side) as acoustic windows.

Study group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient (18 years of age or older)
  • Provided informed consent
  • Supraclavicular block indicated for surgical anesthesia

You may not qualify if:

  • Refusal to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (3)

  • Houston JG, Morris AD, Howie CA, Reid JL, McMillan N. Technical report: quantitative assessment of diaphragmatic movement--a reproducible method using ultrasound. Clin Radiol. 1992 Dec;46(6):405-7. doi: 10.1016/s0009-9260(05)80688-9. No abstract available.

    PMID: 1493655BACKGROUND

  • Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004.

    PMID: 21144957BACKGROUND

  • Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

    PMID: 23344830BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 1, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

CA(1)