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OpenTrials
Completed

NCT Number: NCT01737775

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département d'Anesthésie Hôpital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diaphragmatic amplitude measurement

Procedure

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

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.

    Time frame: two months

Secondary outcomes

  1. All cause morbidity

    Time frame: within the first 28 days after surgery

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: Under the Dome

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 30, 2012
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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