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Recruiting NCT06444854

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

No phase Interventional Lung Surgery Chest Tube Removal Enhanced Recovery After Surgery (ERAS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: early chest tube removal.
Who it may be relevant to
Registry conditions: Lung Surgery, Chest Tube Removal, Enhanced Recovery After Surgery (ERAS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Procedure early chest tube removal
    Chest tube removal

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Complications [Time frame: 30 days post-op]
  • Chest Tube duration [Time frame: 30 days post-op]
  • Unplanned return [Time frame: 30 days post-op]
  • Length Of Stay [Time frame: 30 days post-op]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • London Health Sciences Centre — London

Identifiers

NCT: NCT06444854 · PROTECTR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗