Diaphragmatic DysfunctionUnder the DomeNCT01737775
Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery
A study testing Diaphragmatic amplitude measurement in people with Diaphragmatic Dysfunction, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Diaphragmatic dysfunction (DD) is one of the main risk factors for post operative respiratory distress syndrome. Ultrasonography is a diagnosis tool for DD but few studies have been published. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragmatic Dysfunction
- What is being tested?
- Diaphragmatic amplitude measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Aug 2013
- 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
- Age>18 years
- Upper abdominal or head and neck surgery
- written consent
Who cannot join
- Age <18 years
- Pregnancy
- History of neuropathy or myopathy,
- History of diaphragm paralysis, thoracic surgery, pneumothorax, pneumomediastinum
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'Anesthésie Hôpital de la Croix Rousse
Lyon, Lyon, 69004
About this study
Diaphragmatic dysfunction (DD) is one of the main risk factors for post operative respiratory distress syndrome. Ultrasonography is a diagnosis tool for DD but few studies have been published. The aim of this prospective study is to compare the achievement of diaphragmatic function depending on the type of surgery (abdominal and head and neck surgery).
- Conditions
- Diaphragmatic Dysfunction
- Being tested
- Diaphragmatic amplitude measurement
- Keywords
- diaphragmatic dysfunction, ultrasonography, respiratory distress, abdominal surgery, Age, gender, biometric, body mass index, ASA score, smoking status, history of respiratory disease
- Medical subject headings
- Dyspnea, Coitus, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic amplitude measurementProcedure or surgery
Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| Abdominal laparoscopic surgery (C group) | Experimental | Not described Receives: Procedure: Diaphragmatic amplitude measurement |
| Abdominal surgery by laparotomy (L group) | Experimental | Not described Receives: Procedure: Diaphragmatic amplitude measurement |
| Head and neck surgery (O group) | Experimental | Not described Receives: Procedure: Diaphragmatic amplitude measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of diaphragmatic amplitude measured by M-Mode ultrasonography performed the day before and the day after surgery in 3 groups: laparoscopic abdominal surgery, abdominal surgery by laparotomy and head and neck surgery.
Measured: two months
Secondary outcomes (1)
All cause morbidity
Measured: within the first 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic DysfunctionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737775
- Sponsor's protocol ID
- 2012.718
- Acronym
- Under the Dome
- Status last verified
- Aug 2013
- First submitted
- 23 Nov 2012
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery
- ClinicalTrials.gov ID
- NCT01737775
- Acronym / sponsor ID
- Under the Dome / 2012.718
- Conditions
- Diaphragmatic Dysfunction
- Keywords
- diaphragmatic dysfunction, ultrasonography, respiratory distress, abdominal surgery, Age, gender, biometric, body mass index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Nov 2012 (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.
Diaphragmatic dysfunction (DD) is one of the main risk factors for post operative respiratory distress syndrome. Ultrasonography is a diagnosis tool for DD but few studies have been published. The aim of this prospective study is to compare the achievement of diaphragmatic function depending on the type of surgery (abdominal and head and neck surgery).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abdominal laparoscopic surgery (C group) | Experimental | Procedure: Diaphragmatic amplitude measurement |
| Abdominal surgery by laparotomy (L group) | Experimental | Procedure: Diaphragmatic amplitude measurement |
| Head and neck surgery (O group) | Experimental | Procedure: Diaphragmatic amplitude measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>18 years
- Upper abdominal or head and neck surgery
- written consent
Key exclusion criteria (4 listed)
- Age <18 years
- Pregnancy
- History of neuropathy or myopathy,
- History of diaphragm paralysis, thoracic surgery, pneumothorax, pneumomediastinum
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 amplitude measurementDiaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery | Procedure or surgery | Abdominal laparoscopic surgery (C group), Abdominal surgery by laparotomy (L group), Head and neck surgery (O group) |
Primary outcome
Comparison of diaphragmatic amplitude measured by M-Mode ultrasonography performed the day before and the day after surgery in 3 groups: laparoscopic abdominal surgery, abdominal surgery by laparotomy and head and neck surgery.
Time frame: two months
1 secondary outcome
All cause morbidity
Time frame: within the first 28 days after surgery
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 9 Aug 2013.
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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?
A study testing Diaphragmatic amplitude measurement in people with Diaphragmatic Dysfunction, run by Hospices Civils de Lyon 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 3 inclusion and 4 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 9 Aug 2013. 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?
Comparison of diaphragmatic amplitude measured by M-Mode ultrasonography performed the day before and the day after surgery in 3 groups: laparoscopic abdominal surgery, abdominal surgery by laparotomy and head and neck surgery. (time frame: two months). 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 9 Aug 2013.