NCT01737775

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

9 months

First QC Date

November 23, 2012

Last Update Submit

August 7, 2013

Conditions

Diaphragmatic Dysfunction

Keywords

diaphragmatic dysfunctionultrasonographyrespiratory distressabdominal surgeryAgegenderbiometricbody mass indexASA scoresmoking statushistory of respiratory disease

Outcome Measures

Primary Outcomes (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.

    two months

Secondary Outcomes (1)

  • All cause morbidity

    within the first 28 days after surgery

Study Arms (3)

Abdominal laparoscopic surgery (C group)

EXPERIMENTAL
Procedure: Diaphragmatic amplitude measurement

Abdominal surgery by laparotomy (L group)

EXPERIMENTAL
Procedure: Diaphragmatic amplitude measurement

Head and neck surgery (O group)

EXPERIMENTAL
Procedure: Diaphragmatic amplitude measurement

Interventions

Diaphragmatic amplitude measurementPROCEDURE

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

Abdominal laparoscopic surgery (C group)Abdominal surgery by laparotomy (L group)Head and neck surgery (O group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>18 years
  • Upper abdominal or head and neck surgery
  • written consent

You may not qualify if:

  • Age \<18 years
  • Pregnancy
  • History of neuropathy or myopathy,
  • History of diaphragm paralysis, thoracic surgery, pneumothorax, pneumomediastinum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'Anesthésie Hôpital de la Croix Rousse

Lyon, Lyon, 69004, France

Location

MeSH Terms

Conditions

DyspneaCoitusLung Diseases

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2012

First Posted

November 30, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

FR(1)