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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
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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 or disease Intervention/treatment Phase
Diaphragmatic Dysfunction Procedure: Diaphragmatic amplitude measurement Not Applicable

Study Design
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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
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. All cause morbidity [ Time Frame: within the first 28 days after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
France
Département d'Anesthésie Hôpital de la Croix Rousse
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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