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Sonography After Thoracic Surgery (SATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01152463
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : June 22, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Following thoracic surgery and pulmonary resection, patients have a surgically induced pneumothorax / hydro-hemothorax and hence tube thoracostomy is necessary to drain the air and effusion. Due to this, patients must undergo post-operative chest x-ray (CXR) evaluations in order to evaluate the chest and make decisions regarding removal of chest tubes (CT) as well as for decisions regarding patient discharge. Thoracic Ultrasound (US) has been shown to be accurate at diagnosing pneumothorax and has been well-studied in the trauma population. To the investigators knowledge, there are currently no centers using thoracic US routinely in the post-operative setting following thoracic surgery.

Condition or disease Intervention/treatment
Lung Cancer Procedure: thoracic ultrasound

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Study Design

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sonography After Thoracic Surgery - SATS (CT0011)
Study Start Date : June 2010
Primary Completion Date : September 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: thoracic ultrasound
    daily thoracic ultrasound evaluation of the chest

Outcome Measures

Primary Outcome Measures :
  1. US post thoracic surgery will be measured against CXR in the detection of pneumothorax/pleural effusion. Decisions will be made regarding chest tube removal during rounds, alleviate the need for more CXR as well as decrease patient length of stay. [ Time Frame: on a daily basis ]
    Surgeon performed ultrasound will be compared to plain film CXR, which is considered the "gold standard". If the result of this study show that surgeon performed US is accurate and sensitive in the evaluation of post-operative thoracic surgery patients, US could replace CXR in the post-operative care of these patients

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

  • Patients undergoing elective, open and thoracoscopic thoracic surgery for any indication

Exclusion Criteria:

  • Age < 18 years old
  • Inability to consent for the study
  • Chest wall anatomy precluding SATS
  • Inability to sit upright
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152463

Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Fonds de la Recherche en Santé du Québec
Canada Foundation for Innovation
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Principal Investigator: Moishe Liberman, MD, PhD Centre hospitalier de l'Université de Montréal (CHUM)
More Information

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01152463     History of Changes
Other Study ID Numbers: CE 10.041
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2010

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
thoracic ultrasound (US)
post-op care
pleural effusion