AzTrials
AzTrials

Lung SurgeryPROTECTRNCT06444854

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

A study testing early chest tube removal in people with Lung Surgery and Chest Tube Removal, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
early chest tube removal
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteCanada
Study dates
22 Oct 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • London Health Sciences Centre

    London, Ontario, N6A 5W9

    Deb Lewis, deb.lewis@lhsc.on.ca

    Rahul Nayak, MD MSc

    Recruiting

Other trials in Canada

About this study

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.

Being tested
early chest tube removal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • early chest tube removalProcedure or surgery

    Chest tube removal

Study groups in NCT06444854
Study groupRoleWhat they receive
Early Chest Tube RemovalExperimentalearly chest tube removal at 3 hours
Receives: Procedure: early chest tube removal
Standard of CareNo interventionRoutine post operative chest tube care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of successful same day chest tube removal

    These patients have chest tube removed if they meet study criteria

    Measured: 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.

    Measured: 30 days post-op

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

    Mean Morphine Equivalents used on post operative day 1

    Measured: 24 hours

  4. Pleural reintervention

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

    Measured: 30 days post-op

Secondary outcomes (4)
  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.

    Measured: 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.

    Measured: 30 days post-op

  3. Unplanned return

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

    Measured: 30 days post-op

  4. Length Of Stay

    Duration of hospital length of stay

    Measured: 30 days post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start22 Oct 2024
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model description
This study is a single centre, prospective clinical trial evaluating the safety and feasibility.
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06444854
Sponsor's protocol ID
PROTECTR
Acronym
PROTECTR
Status last verified
Oct 2024
First submitted
30 May 2024
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing early chest tube removal in people with Lung Surgery and Chest Tube Removal, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Deb Lewis (5196858500 ext. 75685, deb.lewis@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of successful same day chest tube removal (time frame: 30 days post-op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in