Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery (Under the Dome)

This study has been completed.

Sponsor:

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

History of Changes

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

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 ]

Secondary Outcome Measures:

All cause morbidity [ Time Frame: within the first 28 days after surgery ]


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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

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 June 23, 2017

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