Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

FOT Assessment of Hemi-diaphragm Dysfunction After Upper Extremity Nerve Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005235
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Milne, Nova Scotia Health Authority

Brief Summary:
Upper extremity nerve blocks of the brachial plexus using local anesthetic can inadvertently affect the ipsilateral phrenic nerve and result in hemidiaphragm dysfunction. Ultrasonography is often used to assess for hemidiaphragm dysfunction after brachial plexus nerve blocks. Alternately, post-operative chest x-rays can also be used to document unilateral hemidiaphragm elevation secondary to phrenic nerve dysfunction. Newly developed passive breathing testing devices (Forced Oscillometry Technique - FOT) use small composite pressure waveforms (5-37Hz) imposed on top of normal breathing and measure the resulting reflected oscillations to assess the mechanical properties of the lungs. The lung resistance R(f) and reactance X(f) are automatically mathematically derived from the reflected pressure waveforms returning from the respiratory system to the FOT device. In this study, we will assess if FOT can be used to detect changes in lung mechanics (lung resistance R(f) and reactance X(f)) after ultrasound proven hemidiaphragm dysfunction secondary to brachial plexus nerve block.

Condition or disease Intervention/treatment
Diaphragm Elevated Paresis Device: Thorasys Tremoflo C-100 Airwave Oscillometry System (FOT)

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Hemi-diaphragm Dysfunction After Upper Extremity Nerve Blocks Using Passive Oscillometry to Measure Lung Mechanics - A Pilot Study.
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Device: Thorasys Tremoflo C-100 Airwave Oscillometry System (FOT)
    Ultrasonography will be used to confirm hemidiaphragm dysfunction after brachial plexus nerve block. In subjects with U/S confirmed hemidiaphragm dysfunction, FOT measurements will be taken before and after nerve block and post-operatively after upper extremity surgery.
    Other Name: Hemidiaphragm ultrasonography


Primary Outcome Measures :
  1. Lung resistance - R(f) changes after brachial plexus block and ultrasound confirmed hemidiaphragm dysfunction [ Time Frame: Baseline FOT measurements taken before nerve block and repeated immediately after ultrasound confirmation of hemidiaphragm dysfunction secondary to nerve block (onset of HDD estimated to be 5-30 mins after nerve block, per serial ultrasound assessments) ]
    Change from baseline FOT measured lung resistance R(f) in cmH2O/L/s

  2. Lung reactance - X(f) changes after brachial plexus block and ultrasound confirmed hemidiaphragm dysfunction [ Time Frame: Baseline FOT measurements taken before nerve block and repeated immediately after ultrasound confirmation of hemidiaphragm dysfunction secondary to nerve block (onset of HDD estimated to be 5-30 mins after nerve block, per serial ultrasound assessments) ]
    Change from baseline FOT measured lung reactance X(f) in cmH2O/L/s


Secondary Outcome Measures :
  1. Subjective patient self reported dyspnea after brachial plexus nerve block [ Time Frame: Every 5 minutes up to 30 minutes after the brachial plexus nerve block ]
    Using standard MBDS scale ("Modified Borg Dyspnea Scale", ordinal scale 0-10, 0 = no difficulty at all, 10 = maximal breathing difficulty)


Other Outcome Measures:
  1. Post-operative Lung resistance - R(f) changes after brachial plexus block with ultrasound confirmed HDD and general anesthetic [ Time Frame: In recovery room 30-60 mins after extubation, when alert enough to be compliant with testing. ]
    Change in FOT measured lung resistance R(f) after general anesthetic (cmH2O/L/s)

  2. Post-operative Lung reactance - X(f) changes after brachial plexus block with ultrasound confirmed HDD and general anesthetic [ Time Frame: In recovery room 30-60 mins after extubation, when alert enough to be compliant with testing. ]
    Change in FOT measured lung reactance X(f) after general anesthetic (cmH2O/L/s)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients requiring interscalene or supraclavicular nerve blocks as part of their routine standard of care, who develop ultrasound confirmed ipsilateral hemdiaphragm dysfunction.
Criteria

Inclusion Criteria:

  • Adult patients > 18 y
  • American Society of Anesthesiologists physical status class 1-3
  • Undergoing upper extremity surgery which requires a pre-operative brachial plexus nerve block as part of their routine standard of care.

Exclusion Criteria:

  • Contraindication to nerve block
  • Pregnant patients
  • Patient refusal or inability to provide informed consent
  • Pre-existing hemidiaphragm dysfunction
  • Any significant neurologic dysfunction, or inability to visualize the diaphragm during baseline sonographic assessment
  • Inability to comply with FOT measurements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005235


Contacts
Layout table for location contacts
Contact: Research Coordinator 9024732331 Flynn.Bonazza@nshealth.ca

Locations
Layout table for location information
Canada, Nova Scotia
NSHA NHI site Recruiting
Halifax, Nova Scotia, Canada, B3H3A7
Contact: A Milne, MD    9024732331      
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Layout table for investigator information
Principal Investigator: Andrew Mine Staff
Publications:

Layout table for additonal information
Responsible Party: Andrew Milne, Principal investigator, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT04005235    
Other Study ID Numbers: FOTHDD1
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Andrew Milne, Nova Scotia Health Authority:
phrenic nerve
nerve block
ultrasonography
breath tests
oscillometry
brachial plexus
Additional relevant MeSH terms:
Layout table for MeSH terms
Paresis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms