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

NCT ID: NCT06444854

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2026-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Chest Tube Removal

early chest tube removal at 3 hours

Group Type: EXPERIMENTAL

early chest tube removal

Intervention Type: PROCEDURE

Chest tube removal

Standard of Care

Routine post operative chest tube care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

early chest tube removal

Chest tube removal

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Rahul Nayak

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rahul Nayak, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Deb Lewis

Role: CONTACT

deb.lewis@lhsc.on.ca

5196858500 ext. 75685

Facility Contacts

Deb Lewis

Role: primary

deb.lewis@lhsc.on.ca

Other Identifiers

PROTECTR

Identifier Type: -

Identifier Source: org_study_id