NCT01152463

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2010

Enrollment Period

3 months

First QC Date

June 2, 2010

Last Update Submit

June 20, 2012

Conditions

Keywords

thoracic ultrasound (US)post-op carepneumothoraxpleural effusion

Outcome Measures

Primary Outcomes (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.

    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

    on a daily basis

Interventions

daily thoracic ultrasound evaluation of the chest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

in-patient

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Lung NeoplasmsPneumothoraxPleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPleural Diseases

Study Officials

  • Moishe Liberman, MD, PhD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 29, 2010

Study Start

June 1, 2010

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

June 22, 2012

Record last verified: 2010-06

Locations