NCT03704870

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_2 lung-cancer

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

January 26, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

May 1, 2020

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

February 28, 2018

Last Update Submit

April 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of total chest xrays performed per subject

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

    30 days

Study Arms (2)

Daily Chest Xray (standard)

ACTIVE COMPARATOR
Diagnostic Test: Chest Xray

Chest Xray post chest tube removal only

EXPERIMENTAL
Diagnostic Test: No daily chest xray

Interventions

Chest XrayDIAGNOSTIC_TEST

Daily chest xray

Daily Chest Xray (standard)
No daily chest xrayDIAGNOSTIC_TEST

Chest xray will be done post chest tube removal only

Chest Xray post chest tube removal only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung NeoplasmsLung DiseasesCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Gail Darling, MD

    UHN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

October 15, 2018

Study Start

January 26, 2018

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

May 1, 2020

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations