Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06444854

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

Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2024-10-28

130

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and feasibility of removing chest tubes on the same day in patients undergoing Video Assisted Thoracic Surgery (VATS) for anatomical lung resections such as segmental or lobar surgeries. This prospective clinical trial aims to improve post-operative care by assessing early chest tube removal compared to routine care, addressing patient discomfort, narcotic use, and potential chronic pain from prolonged chest tube maintenance. The study builds on earlier findings that early removal after minor lung wedge resections reduced opioid use and hospitalization time without adverse effects. Participants are assigned to one of two groups: early chest tube removal approximately 3 hours after surgery or standard post-operative chest tube care. The study focuses on patients undergoing elective VATS segmental or lobar lung resections. The trial is conducted at a single center and monitors outcomes up to 30 days post-operation, including chest tube removal success rates, quality of life, opioid use, and complications. During the study, participants will have their chest tubes managed according to their assigned group and will be monitored for outcomes such as successful early removal, pleural reinterventions, complications, chest tube duration, unplanned returns to care, and length of hospital stay. Quality of life is assessed using the EuroQol 5 Dimension 5 Level (EQ5D5L) score, and opioid use is measured by morphine equivalents on the first postoperative day. Follow-up evaluations continue through 30 days after surgery to ensure safety and collect patient-reported outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Scheduled to undergo elective VATS segmental or lobar lung resection
Not Eligible

You will not qualify if you...

  • Forced expiratory volume in 1 second (FEV1) less than 50% predicted or less than 1.5 liters
  • Diffusion lung capacity of carbon monoxide (DLCO) less than 50% predicted
  • Patient receives intraoperative pleurodesis
  • Conversion to open thoracotomy or mini thoracotomy during surgery
  • Underlying cognitive disorder causing inability to perform daily activities

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 30 days post-surgery

Participants undergo lung surgery followed by either early chest tube removal at 3 hours or routine post-operative chest tube care.

Surgery day and post-operative hospital stay visits

Follow-up

Duration - 30 days post-surgery

Participants are monitored for outcomes including chest tube removal success, complications, pain medication use, and quality of life up to 30 days after surgery.

Approximately 1 to 2 follow-up visits within 30 days post-op

Trial Site Locations

Total: 1 location

1

London Health Sciences Centre

London, Ontario, Canada, N6A 5W9

Actively Recruiting

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Research Team

D

Deb Lewis

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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