Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery

NCT03192865 | Completed DMC

• 1 other identifier: 2014-202
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess consequences and causes of hemidiaphragmatic paralysis for ambulatory arthroscopic shoulder surgery in patients with BMI ≥ 30 kg/m².

Conditions

Dyspnea; Hypoxia; Analgesia

Outcome Measures

Primary Outcomes (1)

• Failure of outpatient arthroscopic shoulder surgery strategy

  failure of outpatient arthroscopic shoulder surgery strategy is communly associated with dyspnea or hypoxia due to diaphragmatic paralysis

  the first 6 hours

Secondary Outcomes (1)

• Assessment of peripheral nerve block strategy associated with diaphragmatic paralysis

  the first 2 hours

Study Arms (2)

diaphragmatic paralysis/paresis group

Diaphragmatic paralysis can be associated with regional anesthesia procedure in arthroscopic shoulder surgery as phrenic nerve is close to the brachial plexus. Diaphragmatic paralysis will be defined using ultrasounds.

Procedure: diaphragmatic assessment using ultrasounds.

No diaphragmatic paralysis/paresis group

Some strategies of peripheral nerve block are able to spare diaphragmatic paralysis.

Procedure: diaphragmatic assessment using ultrasounds.

Interventions

diaphragmatic assessment using ultrasounds. PROCEDURE

A diaphragmatic assessment will be performed using ultrasound. This is a pain free assessment. This assessment is commun in our unit after arthroscopic shoulder surgery.

No diaphragmatic paralysis/paresis group; diaphragmatic paralysis/paresis group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.

You may qualify if:

• All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.

You may not qualify if:

• age \<18 years, brachial plexus neuropathies, severe bronchopulmonary disease, acute respiratory distress, coagulopathies, systemic glucocorticoid use, pregnancy, routine use of opioid medications, intolerance for one or more medications of the study protocol and diabetes.

Sponsors & Collaborators

• Clinique Medipole Garonne: lead

Study Sites (1)

Clinique Medipole Garonne

Toulouse, 31036, France

Location

MeSH Terms

Conditions

Dyspnea; Hypoxia; Agnosia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Design

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

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: October 1, 2014
• Primary Completion: October 2, 2014
• Study Completion: October 30, 2015
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)