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Outcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03704870
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Currently, it is the standard of care practice to perform daily routine CXR when a chest tube is in situ following pulmonary resection. However, previous research as well as experience of thoracic surgeons suggested this kind of management has poor diagnostic and therapeutic value. Eliminating daily routine CXR for adult patients having undergone pulmonary surgery might decrease the frequency of radiation exposure and hospitalization costs per patient without increasing reintervention rates, length of hospital stays, readmission rates or any adverse events.

Condition or disease Intervention/treatment Phase
Lung Cancer Lung Diseases Lung Cancer, Nonsmall Cell Surgery Lung Adenocarcinoma Diagnostic Test: Chest Xray Diagnostic Test: No daily chest xray Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Controlled Feasibility Study Looking at Differences in Hospital Stay Variables Following Omission of Daily Routine Chest Radiographs After Pulmonary Resection.
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Arm Intervention/treatment
Active Comparator: Daily Chest Xray (standard) Diagnostic Test: Chest Xray
Daily chest xray

Experimental: Chest Xray post chest tube removal only Diagnostic Test: No daily chest xray
Chest xray will be done post chest tube removal only




Primary Outcome Measures :
  1. Number of total chest xrays performed per subject [ Time Frame: 30 days ]
    number of scheduled and additional chest xrays, and how does this correlate with post operative safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult males or females who plan to receive VATS pulmonary resections confined to lobectomies, segmentectomies and wedge resections.
  • Willingness to adhere to randomized treatment.
  • Ability to answer self- and interviewer- administered questions in English
  • Understand and sign a written informed consent form in English

Exclusion Criteria:

  • Previous thoracic surgery history in the same side.
  • Exploration, biopsy, lung volume reduction surgeries (LVRS), bilobectomies, sleeve resections or pneumonectomies performed.

Information from the National Library of Medicine

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): NCT03704870


Contacts
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Contact: Jennifer Lister, BSc CCRP 416-340-4857 jennifer.lister@uhn.ca

Locations
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Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Jennifer Lister, BSc CCRP    416-340-4857    Jennifer.Lister@uhn.ca   
Principal Investigator: Gail Darling, MD FRCSC         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Gail Darling, MD UHN

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03704870    
Other Study ID Numbers: 17-5398
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Adenocarcinoma
Adenocarcinoma of Lung
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms