Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery

Diaphragmatic Dysfunction Clinical Trial

— Under the Dome  

Official title:

Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737775
• Other study ID #: 2012.718
• Status: Completed
• Phase: N/A
• First received: November 23, 2012
• Last updated: August 7, 2013
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diaphragmatic Dysfunction

Intervention

Procedure:
• Diaphragmatic amplitude measurement
Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery

Locations

Country	Name	City	State
France	Département d'Anesthésie Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		two months	No
Secondary	All cause morbidity		within the first 28 days after surgery	No