Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411431
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-08
Brief Title:
Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax A Randomized Controlled Trial
Sponsor:
Swedish Medical Center
Organization:
Swedish Medical Center
Study Overview
Official Title:
Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
Video-assisted thoracoscopic surgery VATS with blebectomywedge resection plus pleurodesis is the standard of care for recurrent primary spontaneous pneumothorax PSP or in certain instances after the first episode The chest tube from surgery is typically kept to suction until post-operative day POD 2 to allow for scarring of the lung to the chest to prevent recurrence However the scarring process takes place over a period of weeks and is there no data to support POD2 as the best time to remove the chest tube Also shorter chest tube duration can lower length of stay patient discomfort and hospital cost
The goal of this randomized study is to determine if early removal POD1 of chest tube after video-assisted thoracoscopic surgery VATS with blebectomywedge resection plus chemical pleurodesis for primary spontaneous pneumothorax PSP
has no worse 2-year recurrence rate compared to standard removal POD2
will lower length of stay compared to standard removal
will result in less complications or re-interventions compared to standard removal
Participants will be asked to join prior to surgery Following standard-of-care surgery participants will be screened for randomization If still eligible participants will be randomized for early chest tube removal or standard removal Early Removal will happen within 24 hours after surgery with Standard Removal happening day 2 after surgery
Participants will follow-up with the study team for 2 years on the following schedule
In clinic with a chest x-ray 2 weeks after surgery
By phone 3 months after surgery
In clinic with a chest x-ray 1 year after surgery
In clinic with a chest x-ray 2 years after surgery
The goal of this randomized study is to determine if early removal POD1 of chest tube after video-assisted thoracoscopic surgery VATS with blebectomywedge resection plus chemical pleurodesis for primary spontaneous pneumothorax PSP
has no worse 2-year recurrence rate compared to standard removal POD2
will lower length of stay compared to standard removal
will result in less complications or re-interventions compared to standard removal
Participants will be asked to join prior to surgery Following standard-of-care surgery participants will be screened for randomization If still eligible participants will be randomized for early chest tube removal or standard removal Early Removal will happen within 24 hours after surgery with Standard Removal happening day 2 after surgery
Participants will follow-up with the study team for 2 years on the following schedule
In clinic with a chest x-ray 2 weeks after surgery
By phone 3 months after surgery
In clinic with a chest x-ray 1 year after surgery
In clinic with a chest x-ray 2 years after surgery
Detailed Description:
This study will be a multicentered randomized controlled trial The trial will recruit all adult subjects 18 years old with PSP who are undergoing VATS blebectomywedge resection with chemical pleurodesis from participating centers Subjects will be identified by the surgical team when evaluating a subject with PSP for surgery If screened eligible and not meeting an exclusion criterion the trial will be discussed with them and consent will be obtained
Subjects will undergo VATS with resection of all visible disease or an apical wedge resection if none is found The use of reinforced or non-reinforced staple loads is left to surgeons preference For pleurodesis choice of chemical agent is at the desecration of the surgeon and common practice but limited to 3 agents talc dextrose or a tetracycline antibiotic Surgeons can choose to perform a mechanical pleurodesis as they deem appropriate A single apical chest tube will be placed and connected to a suction device set to at least -20 mmHg of suction Subjects will then be admitted overnight
Subjects will be re-evaluated on the morning of POD1 Those without an air leak with 400 cc of non-bloody chest tube output and having a maximum 1cm of apical pleural separation as determined by the surgeon will be eligible for randomization to either early or standard removal of their chest tube
Randomization will occur in a 11 manner stratified by participating center Subjects within the Early Removal group will have their chest tube removed on postoperative day 1 within 24 hours from the end of the surgery with a follow-up chest x-ray within 6 hours from removal in addition to monitoring of symptoms If the subject remains stable without developing symptoms new oxygen requirement shortness of breath etc or increased pleural separation on x-ray they will be eligible for discharge with appropriate follow-up
Subjects in the Standard Removal group will keep their chest tube to suction until postoperative day 2 The chest tube would be removed on POD2 with a follow up chest x-ray within 6 hours If the subject remains stable without developing symptoms new oxygen requirement shortness of breath etc or growth of pleural separation on chest x-ray they would be eligible for discharge
Subjects will then follow up in clinic within 2 weeks of the operation with a chest x-ray A 3-month follow-up phone call will be performed At 1-year post-operative subjects again will have standard clinic follow up and chest x-ray Finally a 2 year follow up phone call and chest x-ray will be completed
Subjects will undergo VATS with resection of all visible disease or an apical wedge resection if none is found The use of reinforced or non-reinforced staple loads is left to surgeons preference For pleurodesis choice of chemical agent is at the desecration of the surgeon and common practice but limited to 3 agents talc dextrose or a tetracycline antibiotic Surgeons can choose to perform a mechanical pleurodesis as they deem appropriate A single apical chest tube will be placed and connected to a suction device set to at least -20 mmHg of suction Subjects will then be admitted overnight
Subjects will be re-evaluated on the morning of POD1 Those without an air leak with 400 cc of non-bloody chest tube output and having a maximum 1cm of apical pleural separation as determined by the surgeon will be eligible for randomization to either early or standard removal of their chest tube
Randomization will occur in a 11 manner stratified by participating center Subjects within the Early Removal group will have their chest tube removed on postoperative day 1 within 24 hours from the end of the surgery with a follow-up chest x-ray within 6 hours from removal in addition to monitoring of symptoms If the subject remains stable without developing symptoms new oxygen requirement shortness of breath etc or increased pleural separation on x-ray they will be eligible for discharge with appropriate follow-up
Subjects in the Standard Removal group will keep their chest tube to suction until postoperative day 2 The chest tube would be removed on POD2 with a follow up chest x-ray within 6 hours If the subject remains stable without developing symptoms new oxygen requirement shortness of breath etc or growth of pleural separation on chest x-ray they would be eligible for discharge
Subjects will then follow up in clinic within 2 weeks of the operation with a chest x-ray A 3-month follow-up phone call will be performed At 1-year post-operative subjects again will have standard clinic follow up and chest x-ray Finally a 2 year follow up phone call and chest x-ray will be completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None