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Clinical Trials/NCT03192865
NCT03192865CompletedNot Applicable

Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes

Clinique Medipole Garonne1 site in 1 country82 target enrollmentStarted: October 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
82
Locations
1
Primary Endpoint
Failure of outpatient arthroscopic shoulder surgery strategy

Study Overview

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.

Detailed Description

This prospective observational study will screen patients with body mass index (BMI) ≥30 kg/m² undergoing acromioplasty or supraspinatus tendon repair. Occurrence of post-operative hemidiaphragmatic paralysis will be observed using M-mode ultrasonography and its consequences on patient ventilation: arterial oxygen saturation, dyspnea, success of ambulatory procedure. Causes of diaphragmatic paralysis will be analyzed.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Failure of outpatient arthroscopic shoulder surgery strategy

Time Frame: the first 6 hours

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

Secondary Outcomes

  • Assessment of peripheral nerve block strategy associated with diaphragmatic paralysis(the first 2 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Marty Philippe

Dr Anesthesiologist

Clinique Medipole Garonne

Study Sites (1)

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