Clinical trial NCT06444854: Patient Reported Outcomes Targeting Early Chest Tube Removal (PROTECTR) Study
Official title: Patient Reported Outcomes Targeting Early Chest Tube Removal (PROTECTR) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Surgery
Chest Tube Removal
Enhanced Recovery After Surgery (ERAS)
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a single centre, prospective clinical trial evaluating the safety and feasibility.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of successful same day chest tube removal
timeFrame: 30 days post-op
measure: EuroQol 5 Dimension 5 Level (EQ5D5L) score
timeFrame: 30 days post-op
measure: Mean Morphine Equivalents (MME) Post-Operative Day 1 (POD1)
timeFrame: 24 hours
measure: Pleural reintervention
timeFrame: 30 days post-op
Secondary outcomes:
measure: Complications
timeFrame: 30 days post-op
measure: Chest Tube duration
timeFrame: 30 days post-op
measure: Unplanned return
timeFrame: 30 days post-op
measure: Length Of Stay
timeFrame: 30 days post-op
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University
name: Rahul Nayak, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: