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RecruitingNCT06444854PROTECTRUpdated Oct 28, 2024

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

An interventional study of early chest tube removal in Lung Surgery, Chest Tube Removal and Enhanced Recovery After Surgery (ERAS), sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Pulmonary resections are performed for a multitude of diagnostic and therapeutic reasons. The last decade has seen a rapid advancement of minimally invasive surgical (MIS) approaches which have resulted in improved patient outcomes. However, the post-operative care pathways have not evolved sufficiently to account for these changes. As such, many patients are still admitted after a minor lung resection for monitoring with a chest tube remaining in situ for a minimum of 24 hours. There have been a few retrospective cohort studies that demonstrate that patients do not experience significant complications during that 24-hour period that would warrant hospitalization. However, there have been no prospective controlled studies evaluating the safety and feasibility of early chest tube removal and discharge after a wedge resection. Furthermore, the maintenance of a large bore chest tube for an extended period is a cause for increased patient discomfort, increased narcotic use and may contribute to chronic pain secondary to intercostal nerve compression. As such, the prolonged chest tube maintenance and hospitalization may overall result in more patient harm than benefit.

Our group recently completed and presented a prospective safety and feasibility study demonstrating that chest tubes can be discontinued as early as 3 hours after minor MIS wedge resections of the lung with no adverse events. This study validated safety criteria that will be implemented moving forward. Furthermore, the maintenance of a large bore chest tube for an extended period is a cause for increased patient discomfort, increased narcotic use and may contribute to chronic pain secondary to intercostal nerve compression. As such, the prolonged chest tube maintenance and hospitalization may overall result in more patient harm than benefit. In the study mentioned previously, early chest tube removal led to 40% more patients being opioid free at post operative day 1 compared to those who underwent routine care.

Nevertheless, it is unclear if patients who undergo more extensive surgeries involving vascular dissection and longer operative times (i.e., pulmonary lobectomies and segmentectomies) will derive the same benefit. The incisions required to complete more complex operations are also larger compared to wedge resections. As such the pain associated with having a chest tube may or may not be as apparent in the setting of the larger incision. It is also unclear what the long-term impact of early chest tube removal has on quality of life in the perioperative period.

02

Conditions studied

  • Lung Surgery
  • Chest Tube Removal
  • Enhanced Recovery After Surgery (ERAS)
03

In context

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 327 studies on the registry; 132 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Early Chest Tube Removal

    early chest tube removal at 3 hours

    Procedure: early chest tube removal

  • No intervention
    Standard of Care

    Routine post operative chest tube care

Interventions

  • Procedureearly chest tube removal

    Chest tube removal

06

What researchers measure

Primary outcomes

  1. Rate of successful same day chest tube removal

    These patients have chest tube removed if they meet study criteria

    Time frame: 30 days post-op

  2. EuroQol 5 Dimension 5 Level (EQ5D5L) score

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

    Time frame: 30 days post-op

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

    Mean Morphine Equivalents used on post operative day 1

    Time frame: 24 hours

  4. Pleural reintervention

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

    Time frame: 30 days post-op

Secondary outcomes

  1. Complications

    The rates of grade 1 to 5 complications as per the Thoracic Surgery Quality Improvement Canada (TSQIC) will be recorded for up to 30 days after surgery in the divisional thoracic REDCap database.

    Time frame: 30 days post-op

  2. Chest Tube duration

    Duration the patient had chest tubes in situ will be measured by collecting the date and time of arrival to Post anesthesia Care Unit (PACU) and the date and time the chest tube was removed.

    Time frame: 30 days post-op

  3. Unplanned return

    Unplanned returns to clinic or emergency room within the first 30 days after surgery

    Time frame: 30 days post-op

  4. Length Of Stay

    Duration of hospital length of stay

    Time frame: 30 days post-op

07

Study locations

1 of 1 sites recruiting
  • London Health Sciences Centre
    London, Ontario N6A 5W9, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06444854
Responsible party
Rahul Nayak (Director of Research, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Jun 6, 2024
Start date
Oct 22, 2024
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 28, 2024

Study contacts

Deb Lewis
Contact
deb.lewis@lhsc.on.ca
5196858500 ext. 75685
Rahul Nayak, MD MSc
principal investigator · Western University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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