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
  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
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

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 September 30, 2014