- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067738
Same Day Discharge for Wedge Resection
February 8, 2024 updated by: Rahul Nayak, Lawson Health Research Institute
The Development of a Novel Same Day Discharge Program After Pulmonary Resection: A Safety and Feasibility Pilot Study
Monitoring carefully selected participants to determine if participants can be safely discharged the same day of pulmonary resection
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Determination of the feasibility of implementing a same day discharge program after minor pulmonary surgery.
This will be determined by evaluating the percentage of participants who have chest tubes removed successfully, as well as evaluating the percentage of participants who would be classified as discharged on the day of surgery.
The investigators will also be evaluating morbidity associated with this protocol by capturing rates of pleural reintervention.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Patients aged 18 years of age and older who are scheduled to undergo an elective minimally invasive wedge resection of their lung.
Exclusion Criteria:
- Pulmonary function tests demonstrating forced expiratory volume in 1 second (FEV1) <50% predicted, FEV1 <1.5L and/or diffusion lung capacity of carbon monoxide (DLCO) <50% predicted.
- Patient receives an intraoperative pleurodesis.
- Conversion to open thoracotomy or mini thoracotomy intraoperatively.
- Active pregnancy.
- Thoracic Revised Cardiac Risk Index Score (ThRCRI)8 >2.
- Underlying cognitive disorder resulting in inability to complete activities of daily living.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Discharge
Phase 1-Patients will continue to be admitted after their surgery as is the current practice.
Phase 2-Patients will have their chest tube removed once they meet chest tube removal criteria and will be discharged home once they meet discharge criteria.
|
same day discharge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of successful same day discharge
Time Frame: 2 years
|
These patients will have their chest tube removed once they meet chest tube removal criteria and will be discharged home once they meet discharge criteria.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
January 15, 2024
Study Completion (Estimated)
March 31, 2024
Study Registration Dates
First Submitted
September 24, 2021
First Submitted That Met QC Criteria
September 24, 2021
First Posted (Actual)
October 5, 2021
Study Record Updates
Last Update Posted (Estimated)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- v1.0 7 July 2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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