Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444854
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-30
Brief Title:
Patient Reported Outcomes Targeting Early Chest Tube Removal PROTECTR Study
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Patient Reported Outcomes Targeting Early Chest Tube Removal PROTECTR Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECTR
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 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None