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Outcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT03704870
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
26.1
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Diagnostic Test: Chest Xray
  • Diagnostic Test: No daily chest xray
 Phase 2

Study Design

Study Type:
Interventional
Actual 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 :
Jan 26, 2018
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of total chest xrays performed per subject [30 days]

    number of scheduled and additional chest xrays, and how does this correlate with post operative safety

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto General Hospital Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Gail Darling, MD, UHN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT03704870
Other Study ID Numbers:
  • 17-5398
First Posted:
Oct 15, 2018
Last Update Posted:
May 1, 2020
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Adenocarcinoma of Lung
Carcinoma, Non-Small-Cell Lung
Lung Diseases

Study Results

No Results Posted as of May 1, 2020