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Clinical Trials/NCT06444854
NCT06444854
Recruiting
Not Applicable

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

Lawson Health Research Institute1 site in 1 country130 target enrollmentOctober 22, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Surgery
Sponsor
Lawson Health Research Institute
Enrollment
130
Locations
1
Primary Endpoint
Rate of successful same day chest tube removal
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 22, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rahul Nayak

Director of Research

Lawson Health Research Institute

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.

Outcomes

Primary Outcomes

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

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.

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

Time Frame: 24 hours

Mean Morphine Equivalents used on post operative day 1

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

  • Complications(30 days post-op)
  • Chest Tube duration(30 days post-op)
  • Unplanned return(30 days post-op)
  • Length Of Stay(30 days post-op)

Study Sites (1)

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