DyspneaNCT03192865
Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery
An observational study of Dyspnea and Hypoxia, run by Clinique Medipole Garonne at 1 site in France.
Trial summary
This study aims to assess consequences and causes of hemidiaphragmatic paralysis for ambulatory arthroscopic shoulder surgery in patients with BMI ≥ 30 kg/m². Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- diaphragmatic assessment using ultrasounds.
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2014to 30 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.
Who may be able to join
- All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes
This study aims to assess consequences and causes of hemidiaphragmatic paralysis for ambulatory arthroscopic shoulder surgery in patients with BMI ≥ 30 kg/m².
Read the 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.
- Being tested
- diaphragmatic assessment using ultrasounds.
- Medical subject headings
- Dyspnea, Hypoxia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic assessment using ultrasounds.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: diaphragmatic assessment using ultrasounds. | |
| No diaphragmatic paralysis/paresis group | Some strategies of peripheral nerve block are able to spare diaphragmatic paralysis. Receives: Procedure: diaphragmatic assessment using ultrasounds. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the first 6 hours
Secondary outcomes (1)
Assessment of peripheral nerve block strategy associated with diaphragmatic paralysis
Different strategies of peripheral nerve block can be proposed for post-operative pain relief in arthroscopic shoulder surgery.
All strategies were grouped in 3 parts:
- Interscalene block with high volume of local anesthetics
- Interscalene block with low volume of local anesthetics
- distal block
Measured: the first 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Oct 2014
- Primary completion2 Oct 2014
- Study completion30 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Medipole Garonne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Marty Philippe, Clinique Medipole Garonne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192865
- Sponsor's protocol ID
- 2014-202
- Status last verified
- Jul 2017
- First submitted
- 16 Jun 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes
- ClinicalTrials.gov ID
- NCT03192865
- Acronym / sponsor ID
- 2014-202
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Clinique Medipole GaronneUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 2 Oct 2014 (actual)
- Study completion
- 30 Oct 2015 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diaphragmatic paralysis/paresis group | – | Procedure: diaphragmatic assessment using ultrasounds.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. |
| No diaphragmatic paralysis/paresis group | – | Procedure: diaphragmatic assessment using ultrasounds.Some strategies of peripheral nerve block are able to spare diaphragmatic paralysis. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.
Key inclusion criteria (1 listed)
- All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diaphragmatic assessment using ultrasounds.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. | Procedure or surgery | No diaphragmatic paralysis/paresis group, diaphragmatic paralysis/paresis group |
Primary outcome
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
1 secondary outcome
Assessment of peripheral nerve block strategy associated with diaphragmatic paralysis
Time frame: the first 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Hypoxia, run by Clinique Medipole Garonne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of outpatient arthroscopic shoulder surgery strategy (time frame: the first 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.