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NCT Number: NCT06444854

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location status: Recruiting

Location contact

Deb Lewis

CONTACT

[email protected]

Rahul Nayak, MD MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

early chest tube removal

Procedure

Chest tube removal

Primary outcomes

  1. Rate of successful same day chest tube removal

    Time frame: 30 days post-op

    These patients have chest tube removed if they meet study criteria

  2. EuroQol 5 Dimension 5 Level (EQ5D5L) score

    Time frame: 30 days post-op

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

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

    Time frame: 24 hours

    Mean Morphine Equivalents used on post operative day 1

  4. Pleural reintervention

    Time frame: 30 days post-op

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

Secondary outcomes

  1. Complications

    Time frame: 30 days post-op

    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.

  2. Chest Tube duration

    Time frame: 30 days post-op

    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.

  3. Unplanned return

    Time frame: 30 days post-op

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

  4. Length Of Stay

    Time frame: 30 days post-op

    Duration of hospital length of stay

Study contacts

Contact information is provided by the study sponsor or research team.

Deb Lewis

CONTACT

[email protected]

5196858500 ext. 75685

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: PROTECTR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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