Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06444854
Acronym
PROTECTR
Enrollment
130
Registered
2024-06-06
Start date
2024-10-22
Completion date
2026-12-31
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Tube Removal, Enhanced Recovery After Surgery (ERAS), Lung Surgery

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.

Interventions

Chest tube removal

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study is a single centre, prospective clinical trial evaluating the safety and feasibility.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pleural reintervention30 days post-opRate of pleural reintervention (defined as requiring reinsertion of a chest tube or return to the operating room)
Rate of successful same day chest tube removal30 days post-opThese patients have chest tube removed if they meet study criteria
EuroQol 5 Dimension 5 Level (EQ5D5L) score30 days post-opDifference in EQ5D5L scores between standard care and early chest tube removal on POD1 and POD30.
Mean Morphine Equivalents (MME) Post-Operative Day 1 (POD1)24 hoursMean Morphine Equivalents used on post operative day 1

Secondary

MeasureTime frameDescription
Complications30 days post-opThe 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.
Chest Tube duration30 days post-opDuration 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.
Unplanned return30 days post-opUnplanned returns to clinic or emergency room within the first 30 days after surgery
Length Of Stay30 days post-opDuration of hospital length of stay

Countries

Canada

Contacts

Primary ContactDeb Lewis
deb.lewis@lhsc.on.ca5196858500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026