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

NCT ID: NCT01737775

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Diaphragmatic Dysfunction

Keywords

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diaphragmatic dysfunction ultrasonography respiratory distress abdominal surgery Age gender biometric body mass index ASA score smoking status history of respiratory disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Abdominal laparoscopic surgery (C group)

Group Type EXPERIMENTAL

Diaphragmatic amplitude measurement

Intervention Type PROCEDURE

Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery

Abdominal surgery by laparotomy (L group)

Group Type EXPERIMENTAL

Diaphragmatic amplitude measurement

Intervention Type PROCEDURE

Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery

Head and neck surgery (O group)

Group Type EXPERIMENTAL

Diaphragmatic amplitude measurement

Intervention Type PROCEDURE

Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery

Interventions

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Diaphragmatic amplitude measurement

Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Département d'Anesthésie Hôpital de la Croix Rousse

Lyon, Lyon, France

Site Status

Countries

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France

Other Identifiers

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2012.718

Identifier Type: -

Identifier Source: org_study_id