Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery (Under the Dome)
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ClinicalTrials.gov Identifier: NCT01737775 |
Recruitment Status
:
Completed
First Posted
: November 30, 2012
Last Update Posted
: August 9, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diaphragmatic Dysfunction | Procedure: Diaphragmatic amplitude measurement | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | August 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Abdominal laparoscopic surgery (C group) |
Procedure: Diaphragmatic amplitude measurement
Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery
|
Experimental: Abdominal surgery by laparotomy (L group) |
Procedure: Diaphragmatic amplitude measurement
Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery
|
Experimental: Head and neck surgery (O group) |
Procedure: Diaphragmatic amplitude measurement
Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery
|
- 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 ]
- All cause morbidity [ Time Frame: within the first 28 days after surgery ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age>18 years
- Upper abdominal or head and neck surgery
- written consent
Exclusion Criteria:
- Age <18 years
- Pregnancy
- History of neuropathy or myopathy,
- History of diaphragm paralysis, thoracic surgery, pneumothorax, pneumomediastinum

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737775
France | |
Département d'Anesthésie Hôpital de la Croix Rousse | |
Lyon, France, 69004 |
Responsible Party: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT01737775 History of Changes |
Other Study ID Numbers: |
2012.718 |
First Posted: | November 30, 2012 Key Record Dates |
Last Update Posted: | August 9, 2013 |
Last Verified: | August 2013 |
Keywords provided by Hospices Civils de Lyon:
diaphragmatic dysfunction ultrasonography respiratory distress abdominal surgery Age gender |
biometric body mass index ASA score smoking status history of respiratory disease |