Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery (Under the Dome)
This study has been completed.
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01737775
First received: November 23, 2012
Last updated: August 7, 2013
Last verified: August 2013
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Diaphragmatic Dysfunction |
Procedure: Diaphragmatic amplitude measurement |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery |
Resource links provided by NLM:
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- All cause morbidity [ Time Frame: within the first 28 days after surgery ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | October 2012 |
| Study Completion Date: | August 2013 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01737775
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737775
Locations
| France | |
| Département d'Anesthésie Hôpital de la Croix Rousse | |
| Lyon, France, 69004 | |
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01737775 History of Changes |
| Other Study ID Numbers: | 2012.718 |
| Study First Received: | November 23, 2012 |
| Last Updated: | August 7, 2013 |
| Health Authority: | France: The Commission nationale de l’informatique et des libertés France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: Agence Nationale de Sécurité du Médicament et des produits de santé |
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 |
ClinicalTrials.gov processed this record on March 03, 2015