Sonography After Thoracic Surgery (SATS)

This study has been completed.
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
Canada Foundation for Innovation
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01152463
First received: June 2, 2010
Last updated: June 20, 2012
Last verified: June 2010
  Purpose

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 Intervention
Lung Cancer
Procedure: thoracic ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sonography After Thoracic Surgery - SATS (CT0011)

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 120
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: thoracic ultrasound
    daily thoracic ultrasound evaluation of the chest
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

in-patient

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152463

Locations
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
Investigators
Principal Investigator: Moishe Liberman, MD, PhD Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01152463     History of Changes
Other Study ID Numbers: CE 10.041
Study First Received: June 2, 2010
Last Updated: June 20, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014