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

NCT04005235 | Terminated FDA Device

• 1 other identifier: FOTHDD1
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragm Elevated; Paresis

Keywords

phrenic nerve; nerve block; ultrasonography; breath tests; oscillometry; brachial plexus

Outcome Measures

Primary Outcomes (2)

• Lung resistance - R(f) changes after brachial plexus block and ultrasound confirmed hemidiaphragm dysfunction

  Change from baseline FOT measured lung resistance R(f) in cmH2O/L/s

  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)

• Lung reactance - X(f) changes after brachial plexus block and ultrasound confirmed hemidiaphragm dysfunction

  Change from baseline FOT measured lung reactance X(f) in cmH2O/L/s

  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)

Secondary Outcomes (1)

• Subjective patient self reported dyspnea after brachial plexus nerve block

  Every 5 minutes up to 30 minutes after the brachial plexus nerve block

Other Outcomes (2)

• Post-operative Lung resistance - R(f) changes after brachial plexus block with ultrasound confirmed HDD and general anesthetic

  In recovery room 30-60 mins after extubation, when alert enough to be compliant with testing.

• Post-operative Lung reactance - X(f) changes after brachial plexus block with ultrasound confirmed HDD and general anesthetic

  In recovery room 30-60 mins after extubation, when alert enough to be compliant with testing.

Interventions

Thorasys Tremoflo C-100 Airwave Oscillometry System (FOT) DEVICE

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.

Also known as: Hemidiaphragm ultrasonography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

NSHA NHI site

Halifax, Nova Scotia, B3H3A7, Canada

Location

Related Publications (9)

• Khurana J, Gartner SC, Naik L, Tsui BCH. Ultrasound Identification of Diaphragm by Novices Using ABCDE Technique. Reg Anesth Pain Med. 2018 Feb;43(2):161-165. doi: 10.1097/AAP.0000000000000718.

  PMID: 29315130 BACKGROUND

• Gerscovich EO, Cronan M, McGahan JP, Jain K, Jones CD, McDonald C. Ultrasonographic evaluation of diaphragmatic motion. J Ultrasound Med. 2001 Jun;20(6):597-604. doi: 10.7863/jum.2001.20.6.597.

  PMID: 11400933 BACKGROUND

• Kuzukawa Y, Nakahira J, Sawai T, Minami T. A Perioperative Evaluation of Respiratory Mechanics Using the Forced Oscillation Technique. Anesth Analg. 2015 Nov;121(5):1202-6. doi: 10.1213/ANE.0000000000000720.

  PMID: 25839180 BACKGROUND

• Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.

  PMID: 2006740 BACKGROUND

• Knoblanche GE. The incidence and aetiology of phrenic nerve blockade associated with supraclavicular brachial plexus block. Anaesth Intensive Care. 1979 Nov;7(4):346-9. doi: 10.1177/0310057X7900700406.

  PMID: 525758 BACKGROUND

• Neal JM, Moore JM, Kopacz DJ, Liu SS, Kramer DJ, Plorde JJ. Quantitative analysis of respiratory, motor, and sensory function after supraclavicular block. Anesth Analg. 1998 Jun;86(6):1239-44. doi: 10.1097/00000539-199806000-00020.

  PMID: 9620512 BACKGROUND

• Mak PH, Irwin MG, Ooi CG, Chow BF. Incidence of diaphragmatic paralysis following supraclavicular brachial plexus block and its effect on pulmonary function. Anaesthesia. 2001 Apr;56(4):352-6. doi: 10.1046/j.1365-2044.2001.01708-2.x.

  PMID: 11284823 BACKGROUND

• Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.

  PMID: 14680096 BACKGROUND

• Kanda S, Fujimoto K, Komatsu Y, Yasuo M, Hanaoka M, Kubo K. Evaluation of respiratory impedance in asthma and COPD by an impulse oscillation system. Intern Med. 2010;49(1):23-30. doi: 10.2169/internalmedicine.49.2191. Epub 2010 Jan 1.

  PMID: 20045997 BACKGROUND

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Mine

  Staff

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 2, 2019
• Study Start: July 31, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)