Patient Reported Outcomes Targeting Early Chest Tube Removal (PROTECTR) Study

NCT06444854 | Recruiting

• 1 other identifier: PROTECTR
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single centre, prospective clinical trial evaluating the safety and feasibility of implementing a same day chest tube removal protocol in patients undergoing Video Assisted Thoracic Surgery (VATS) anatomical pulmonary surgery.

Conditions

Lung Surgery; Chest Tube Removal; Enhanced Recovery After Surgery (ERAS)

Outcome Measures

Primary Outcomes (4)

• Rate of successful same day chest tube removal

  These patients have chest tube removed if they meet study criteria

  30 days post-op

• EuroQol 5 Dimension 5 Level (EQ5D5L) score

  Difference in EQ5D5L scores between standard care and early chest tube removal on POD1 and POD30.

  30 days post-op

• Mean Morphine Equivalents (MME) Post-Operative Day 1 (POD1)

  Mean Morphine Equivalents used on post operative day 1

  24 hours

• Pleural reintervention

  Rate of pleural reintervention (defined as requiring reinsertion of a chest tube or return to the operating room)

  30 days post-op

Secondary Outcomes (4)

• Complications

  30 days post-op

• Chest Tube duration

  30 days post-op

• Unplanned return

  30 days post-op

• Length Of Stay

  30 days post-op

Study Arms (2)

Early Chest Tube Removal

EXPERIMENTAL

early chest tube removal at 3 hours

Procedure: early chest tube removal

Standard of Care

NO INTERVENTION

Routine post operative chest tube care

Interventions

early chest tube removal PROCEDURE

Chest tube removal

Early Chest Tube Removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs or older
• scheduled to undergo elective VATS segmental or lobar resection of the lung

You may not qualify if:

• Pulmonary function tests demonstrating forced expiratory volume in 1 second Forced Expiratory Volume (FEV1) \<50% predicted, FEV1 \<1.5L and/or diffusion lung capacity of carbon monoxide Lung Diffusion Test (DLCO) \<50% predicted
• Patient receives an intraoperative pleurodesis
• Conversion to open thoracotomy or mini thoracotomy intraoperatively.
• Underlying cognitive disorder resulting in inability to complete activities of daily living.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Study Officials

• Rahul Nayak, MD MSc

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deb Lewis

CONTACT

5196858500; deb.lewis@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: This study is a single centre, prospective clinical trial evaluating the safety and feasibility.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 6, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)