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Same Day Discharge for Wedge Resection

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05067738
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
21.3
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Monitoring carefully selected participants to determine if participants can be safely discharged the same day of pulmonary resection

Condition or Disease Intervention/Treatment Phase
  • Other: same day discharge
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
2 phases2 phases
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Development of a Novel Same Day Discharge Program After Pulmonary Resection: A Safety and Feasibility Pilot Study
Actual Study Start Date :
Dec 23, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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.

Other: same day discharge
same day discharge

Outcome Measures

Primary Outcome Measures

  1. Rate of successful same day discharge [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.

Eligibility Criteria

Criteria

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

  1. Pulmonary function tests demonstrating forced expiratory volume in 1 second (FEV1) <70% predicted, FEV1 <1.5L and/or diffusion lung capacity of carbon monoxide (DLCO) <70% predicted.

  2. Patients is an active smoker within 4 weeks of their surgery.

  3. Patient receives an intraoperative pleurodesis.

  4. Conversion to open thoracotomy or mini thoracotomy intraoperatively.

  5. Any history or suspicion of untreated obstructive sleep apnea.

  6. Active pregnancy.

  7. Thoracic Revised Cardiac Risk Index Score (ThRCRI)8 >2.

  8. Underlying cognitive disorder resulting in inability to complete activities of daily living.

Contacts and Locations

Locations

Site City State Country Postal Code
1 London Health Sciences Centre London Ontario Canada N6A 5W9

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rahul Nayak, Director of Research, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT05067738
Other Study ID Numbers:
  • v1.0 7 July 2021
First Posted:
Oct 5, 2021
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
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

Study Results

No Results Posted as of Apr 26, 2022