Recruiting

VATS

Sponsor:

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

Code:

NCT06444854

Conditions

Lung Surgery

Chest Tube Removal

Enhanced Recovery After Surgery (ERAS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

early chest tube removal

Study Details

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)

Study ID

NCT06444854

Start date

Oct 22, 2024

Status verified date

Oct, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early Chest Tube Removal

early chest tube removal at 3 hours

no intervention: Standard of Care

Routine post operative chest tube care

Interventions

early chest tube removal

Chest tube removal

Primary outcome measure

  • Rate of successful same day chest tube removal [ Time Frame: 30 days post-op ]
  • EuroQol 5 Dimension 5 Level (EQ5D5L) score [ Time Frame: 30 days post-op ]
  • Mean Morphine Equivalents (MME) Post-Operative Day 1 (POD1) [ Time Frame: 24 hours ]
  • Pleural reintervention [ Time Frame: 30 days post-op ]

Central Contacts and Locations

Central contacts

Deb Lewis

5196858500deb.lewis@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Deb Lewis

deb.lewis@lhsc.on.ca

Principal Investigator:

Rahul Nayak, MD MSc

More Information

Sponsor

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

Last update posted

Oct 28, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-10-28.