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

ERAS Clinical Trial

— PROTECTR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444854
• Other study ID #: PROTECTR
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Lawson Health Research Institute
• Contact: Deb Lewis
• Phone: 5196858500
• Email: deb.lewis[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (MI) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 31, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (FEV1) <50% predicted, FEV1 <1.5L and/or diffusion lung capacity of carbon monoxide (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.

Related Conditions & MeSH terms

• Chest Tube Removal
• ERAS
• Lung Surgery

Intervention

Procedure:
• early chest tube removal
Chest tube removal

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful same day chest tube removal	These patients have chest tube removed if they meet study criteria	30 days post-op
Primary	EQ5D5L score	Difference in EQ5D5L scores between standard care and early chest tube removal on POD1 and POD30.	30 days post-op
Primary	MME POD1	Mean Morphine Equivalents used on post operative day 1	24 hours
Primary	Pleural reintervention	Rate of pleural reintervention (defined as requiring reinsertion of a chest tube or return to the operating room)	30 days post-op
Secondary	Complications	The rates of grade 1 to 5 complications as per the TSQIC will be recorded for up to 30 days after surgery in the divisional thoracic REDCap database.	30 days post-op
Secondary	Chest Tube duration	Duration the patient had chest tubes in situ will be measured by collecting the date and time of arrival to PACU and the date and time the chest tube was removed.	30 days post-op
Secondary	Unplanned return	Unplanned returns to clinic or emergency room within the first 30 days after surgery	30 days post-op
Secondary	LOS	Duration of hospital length of stay	30 days post-op