Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05638113
Status:
RECRUITING
Last Update Posted:
2023-03-22
First Post:
2022-11-17
Brief Title:
Prolonged Air Leakage After Major Lung Resection
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Prolonged Air Leakage After Major Lung Resection
Status:
RECRUITING
Status Verified Date:
2023-03
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:
PRAL
Brief Summary:
The goal of this prospective randomized controlled trial is to investigate the clinical effects of autologous blood pleurodesis in the treatment of pulmonary air leaks on the first postoperative day following VATS pulmonary resections Patients will through web-based randomization be randomly assigned into intrapleural instillation of autologous blood intervention or standard treatment with ordinary chest drainage control
Detailed Description:
The investigators will conduct a randomized controlled trial enrolling patients undergoing elective VATS-lobectomy Patients will be randomly assigned into two groups through web-based randomization Air leak will be measured intraoperatively by submersion tests and postoperatively using standard electronic chest tube devices Thopaz with a regulated pressure of -10 cmH2O If an air leak is present on the 1st postoperative day 20 mlmin or greater for at least 6 hours patients will be invited to participate in this study
Following informed consent the patient is randomized on a web-based randomization module to receive intervention or observation The intervention group will receive intrapleural instillation of autologous blood in accordance with the standard blood patch protocol at Odense University Hospital In short 120 ml autologous blood will be drawn from simple venous puncture and immediately injected through the drain into the pleural cavity followed by flushing with 50ml of saline No anticoagulation or coagulating agents will be added All other aspects of the patients postoperative management will be according to the departments standard protocols
Standard preoperative information on smoking status medications medical history of lung diseases BMI spirometry as well as DLCO measurements will be recorded Detailed information about the surgical treatment will also be recorded site of anatomical resection adherences standard perioperative assessment of air leakage and type of mechanical linear staplers
All chest drains will be connected to a standard electronic chest tube device Thopaz for continuous recording of air leakage and the drain is removed during daytime or evening shifts when air leakage has ceased to 20 mlmin or less for at least 6 hours according to the standard postoperative management In addition all included patients will undergo standard postoperative observations including recording of vital signs blood pressure heart rate fever saturation- and standard blood samples CRP and leukocyte count on postoperative day 2 and subsequent daily if there is a suspicion of infection pleural effusions empyema and drain-site infections Pain will be assessed twice daily using a standardized 0-10 visual analog scale VAS where 0 represents no pain and 10 the worst imaginable pain
Electronic recordings of air leakage from the electronic chest tube device will be analyzed from drain placement in the operating room until drain removal If air leakage is still present on postoperative day 7 treatment is considered a failure and further management will be individualized by the responsible surgeon including the need for re-operation in accordance with the departments standard of care
In the control group everything listed above will apply in the same manner except the intrapleural instillation of autologous blood
Following informed consent the patient is randomized on a web-based randomization module to receive intervention or observation The intervention group will receive intrapleural instillation of autologous blood in accordance with the standard blood patch protocol at Odense University Hospital In short 120 ml autologous blood will be drawn from simple venous puncture and immediately injected through the drain into the pleural cavity followed by flushing with 50ml of saline No anticoagulation or coagulating agents will be added All other aspects of the patients postoperative management will be according to the departments standard protocols
Standard preoperative information on smoking status medications medical history of lung diseases BMI spirometry as well as DLCO measurements will be recorded Detailed information about the surgical treatment will also be recorded site of anatomical resection adherences standard perioperative assessment of air leakage and type of mechanical linear staplers
All chest drains will be connected to a standard electronic chest tube device Thopaz for continuous recording of air leakage and the drain is removed during daytime or evening shifts when air leakage has ceased to 20 mlmin or less for at least 6 hours according to the standard postoperative management In addition all included patients will undergo standard postoperative observations including recording of vital signs blood pressure heart rate fever saturation- and standard blood samples CRP and leukocyte count on postoperative day 2 and subsequent daily if there is a suspicion of infection pleural effusions empyema and drain-site infections Pain will be assessed twice daily using a standardized 0-10 visual analog scale VAS where 0 represents no pain and 10 the worst imaginable pain
Electronic recordings of air leakage from the electronic chest tube device will be analyzed from drain placement in the operating room until drain removal If air leakage is still present on postoperative day 7 treatment is considered a failure and further management will be individualized by the responsible surgeon including the need for re-operation in accordance with the departments standard of care
In the control group everything listed above will apply in the same manner except the intrapleural instillation of autologous blood
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