Shoulder FracturesBBDDIAPHRAGMNCT02539173
Diagnosis of Diaphragmatic Paralysis After Interscalene Block: Feasibility and Impact Observed
A study testing Ultrasound scan in people with Shoulder Fractures and Arm Fractures, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
1. INTRODUCTION AND MAIN OBJECTIVES The incidence of diaphragmatic paralysis after an inter-block scalénique varies between 30 and 100% in the literature. Its clinical impact is mostly absent and paralysis regresses after the block lifted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Fractures, Arm Fractures
- What is being tested?
- Ultrasound scan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2014to 1 Nov 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients
Who cannot join
- Minor patients
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Diagnosis of Diaphragmatic Paralysis After Interscalene Block by Measuring the Inspiratory Diaphragmatic Thickening: Feasibility and Impact Observed
- INTRODUCTION AND MAIN OBJECTIVES The incidence of diaphragmatic paralysis after an inter-block scalénique varies between 30 and 100% in the literature. Its clinical impact is mostly absent and paralysis regresses after the block lifted. When it is suspected, it can be diagnosed by a chest radio, showing an elevation of the dome. The objective of this study is to evaluate the incidence of diaphragmatic paralysis by measuring the thickness diaphragmatic as quantitative assessment of diaphragmatic contraction noninvasive ultrasound scan and feasibility of this measure in SSPI unit (post-interventional monitoring unit) with scan (ultrasound) in the usual way used for the block under ultrasound scan.
- STUDY TYPE Prospective, single-center clinical study routine care involving 50 consecutive patients scheduled to undergo surgical procedures in the area of the shoulder or arm for which locoregional analgesia inter-block type scalénique or supraclavicular ultrasound scan is indicated below.
- START OF THE STUDY February 2014 with an expected duration of six months.
Read the detailed description
- TITLE OF STUDY Diagnosis of diaphragmatic paralysis after interscalene block by measuring the inspiratory diaphragmatic thickening incidence and observed clinical consequences.
- OBJECTIVES OF THE STUDY 2.1 Primary Objective: To evaluate the incidence and clinical impact of diaphragmatic paralysis after interscalene block under ultrasound. To evaluate the clinical consequences of this paralysis. Quantify diaphragmatic paralysis: paralysis if present is it always complete. 2.2 Secondary objective: Assess the feasibility of measuring the diaphragmatic thickening as a means simple diagnostics, rapid, non-invasive and non-irradiating bedside by the anesthetist in charge of the patient with the conventional ultrasound equipment available in the operating room without staff intervention Outdoor (radio manipulator, radiologist).
- STUDY TYPE Single-center prospective study in routine care involving 50 consecutive patients conducted from February 2014 for 6 months.
- LOCATION OF THE STUDY The study will take place in recovery and in the operating theater of the hospital Saint Joseph 185 Rue Raymond Losserand 75014 Paris. The information and the collection of patient consent will be held in pre-anesthetic visit.
- RUNNING OF THE STUDY
5.1 Study Population Major patients scheduled to undergo surgical procedures in the area of the shoulder or arm for which locoregional analgesia inter-block type scalénique or supraclavicular ultrasound is indicated below.
5.2 anesthetic Protocol Block design: as recommended by SFAR, usual procedure In immediate preoperative patient monitored and infused, fractionated ultrasound-guided injection of 20 ml of 7.5% Naropin.
The surgery is then performed under general anesthesia according to the usual anesthetic protocol.
5.2 Recruitment Mode Preoperatively during the pre-anesthetic visit, patients are informed of the purpose of the study. Written consent is collected after oral and written information.
5.3 Data collection The collected data about the patient are ASA, weight, age, gender, block type, type of surgery, the occurrence of complications of the ALR, the administration of prophylactic antibiotics and dexamethasone , respiratory pathology history, renal function, drug class premedication, the occurrence of respiratory complications. The data is then entered in a EXCEL spreadsheet whose treatment will remain internal to GHPSJ.
5.4 Ultrasound examination of the diaphragm It is non-invasive and non-irradiating. The diaphragmatic thickening in recovery is measured before and after the completion of the anesthetic block using the ultrasound system, the ultrasound probe and of an aqueous gel by trans-thoracic approach.
It measures the thickness on deep inspiration and expiration in supine position. Each measurement is repeated twice. This measurement series lasts 4 minutes, is repeated 15 minutes after completion of the engine block when a block is found and contralateral. The total measurement time is about 12 minutes.
5.5 Diagnosis of diaphragmatic dysfunction Diaphragmatic paralysis is recognized when the inspiratory diaphragmatic thickening fraction is less than 20%.
- SCHEDULED DATE FOR START OF THE STUDY: FEBRUARY 2014
- PLANNED DURATION OF THE STUDY: 6 MONTHS
- Conditions
- Shoulder Fractures, Arm Fractures
- Being tested
- Ultrasound scan
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanOther
Non-invasive and non-irradiating. The diaphragmatic thickening in recovery is measured before and after the completion of the anesthetic block using the ultrasound system, the ultrasound probe and of an aqueous gel by trans-thoracic approach.
It measures the thickness on deep inspiration and expiration in supine position. Each measurement is repeated twice. This measurement series lasts 4 minutes, is repeated 15 minutes after completion of the engine block when a block is found and contralateral. The total measurement time is about 12 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Ultrasound scan of diaphragm is made preoperatively during the pre-anesthetic visit, patients are informed of the purpose of the study. Written consent is collected after oral and written information. Receives: Other: Ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickening on deep inspiration and expiration in supine position. The fraction is estimated by percentage
Measured: The measurement series lasts 4 minutes, is repeated 15 minutes after completion of the engine block when a block is found and contralateral. The total measurement time is about 12 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start1 Jun 2014
- Primary completion1 Oct 2015
- Study completion1 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Belaid BOUHEMAD, Dr, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539173
- Sponsor's protocol ID
- FONCTION DIAPHRAGMATIQUE
- Acronym
- BBDDIAPHRAGM
- Status last verified
- Aug 2015
- First submitted
- 26 Aug 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Diaphragmatic Paralysis After Interscalene Block by Measuring the Inspiratory Diaphragmatic Thickening: Feasibility and Impact Observed
- ClinicalTrials.gov ID
- NCT02539173
- Acronym / sponsor ID
- BBDDIAPHRAGM / FONCTION DIAPHRAGMATIQUE
- Conditions
- Shoulder Fractures, Arm Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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.
- INTRODUCTION AND MAIN OBJECTIVES The incidence of diaphragmatic paralysis after an inter-block scalénique varies between 30 and 100% in the literature. Its clinical impact is mostly absent and paralysis regresses after the block lifted. When it is suspected, it can be diagnosed by a chest radio, showing an elevation of the dome. The objective of this study is to evaluate the incidence of diaphragmatic paralysis by measuring the thickness diaphragmatic as quantitative assessment of diaphragmatic contraction noninvasive ultrasound scan and feasibility of this measure in SSPI unit (post-interventional monitoring unit) with scan (ultrasound) in the usual way used for the block under ultrasound scan.
- STUDY TYPE Prospective, single-center clinical study routine care involving 50 consecutive patients scheduled to undergo surgical procedures in the area of the shoulder or arm for which locoregional analgesia inter-block type scalénique or supraclavicular ultrasound scan is indicated below.
- START OF THE STUDY February 2014 with an expected duration of six months.
Detailed description
- TITLE OF STUDY Diagnosis of diaphragmatic paralysis after interscalene block by measuring the inspiratory diaphragmatic thickening incidence and observed clinical consequences.
- OBJECTIVES OF THE STUDY 2.1 Primary Objective: To evaluate the incidence and clinical impact of diaphragmatic paralysis after interscalene block under ultrasound. To evaluate the clinical consequences of this paralysis. Quantify diaphragmatic paralysis: paralysis if present is it always complete. 2.2 Secondary objective: Assess the feasibility of measuring the diaphragmatic thickening as a means simple diagnostics, rapid, non-invasive and non-irradiating bedside by the anesthetist in charge of the patient with the conventional ultrasound equipment available in the operating room without staff intervention Outdoor (radio manipulator, radiologist).
- STUDY TYPE Single-center prospective study in routine care involving 50 consecutive patients conducted from February 2014 for 6 months.
- LOCATION OF THE STUDY The study will take place in recovery and in the operating theater of the hospital Saint Joseph 185 Rue Raymond Losserand 75014 Paris. The information and the collection of patient consent will be held in pre-anesthetic visit.
- RUNNING OF THE STUDY
5.1 Study Population Major patients scheduled to undergo surgical procedures in the area of the shoulder or arm for which locoregional analgesia inter-block type scalénique or supraclavicular ultrasound is indicated below.
5.2 anesthetic Protocol Block design: as recommended by SFAR, usual procedure In immediate preoperative patient monitored and infused, fractionated ultrasound-guided injection of 20 ml of 7.5% Naropin.
The surgery is then performed under general anesthesia according to the usual anesthetic protocol.
5.2 Recruitment Mode Preoperatively during the pre-anesthetic visit, patients are informed of the purpose of the study. Written consent is collected after oral and written information.
5.3 Data collection The collected data about the patient are ASA, weight, age, gender, block type, type of surgery, the occurrence of complications of the ALR, the administration of prophylactic antibiotics and dexamethasone , respiratory pathology history, renal function, drug class premedication, the occurrence of respiratory complications. The data is then entered in a EXCEL spreadsheet whose treatment will remain internal to GHPSJ.
5.4 Ultrasound examination of the diaphragm It is non-invasive and non-irradiating. The diaphragmatic thickening in recovery is measured before and after the completion of the anesthetic block using the ultrasound system, the ultrasound probe and of an aqueous gel by trans-thoracic approach.
It measures the thickness on deep inspiration and expiration in supine position. Each measurement is repeated twice. This measurement series lasts 4 minutes, is repeated 15 minutes after completion of the engine block when a block is found and contralateral. The total measurement time is about 12 minutes.
5.5 Diagnosis of diaphragmatic dysfunction Diaphragmatic paralysis is recognized when the inspiratory diaphragmatic thickening fraction is less than 20%.
- SCHEDULED DATE FOR START OF THE STUDY: FEBRUARY 2014
- PLANNED DURATION OF THE STUDY: 6 MONTHS
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Ultrasound scanUltrasound scan of diaphragm is made preoperatively during the pre-anesthetic visit, patients are informed of the purpose of the study. Written consent is collected after oral and written information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients
Key exclusion criteria (1 listed)
- Minor patients
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 |
|---|---|---|
| Ultrasound scanNon-invasive and non-irradiating. The diaphragmatic thickening in recovery is measured before and after the completion of the anesthetic block using the ultrasound system, the ultrasound probe and of an aqueous gel by trans-thoracic approach. It measures the thickness on deep inspiration and expiration in supine position. Each measurement is repeated twice. This measurement series lasts 4 minutes, is repeated 15 minutes after completion of the engine block when a block is found and contralateral. The total measurement time is about 12 minutes. | Other | Experimental |
Primary outcome
Diaphragmatic thickening on deep inspiration and expiration in supine position. The fraction is estimated by percentage
Time frame: The measurement series lasts 4 minutes, is repeated 15 minutes after completion of the engine block when a block is found and contralateral. The total measurement time is about 12 minutes.
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 7 Mar 2017.
Related trials for Shoulder Fractures
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
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.
Belaid BOUHEMAD, Dr principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound scan in people with Shoulder Fractures and Arm Fractures, run by Fondation Hôpital Saint-Joseph 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 7 Mar 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?
Diaphragmatic thickening on deep inspiration and expiration in supine position. The fraction is estimated by percentage (time frame: The measurement series lasts 4 minutes, is repeated 15 minutes after completion of the engine block when a block is found and contralateral. The total measurement time is about 12 minutes.). 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 7 Mar 2017.