Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544200
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection Randomized Comparison Between Polymeric Hydrogel Matrix and Standard of Care
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In patients undergoing minimally invasive thoracoscopic surgery video-assisted thoracoscopic surgery or VATS a still unsolved issue is represented by intraoperative alveolar air leaks IOAALs which if prolonged beyond the fifth postoperative day can lead to higher risk of complications and higher medical costs The polymeric hydrogel matrix PHM is a novel tool to manage intraoperative IOAALs The primary end-point of our study was to verify whether PHM would be able to reduce postoperative air leaks secondary end-points were the possible reduction of the permanence time of the chest drain CD and the hospital length HL in the PHM group compared with no treatment
Detailed Description:
The management of postoperative air leaks remains an unresolved issue in pulmonary resections This complication can be present in up to 75 of patients undergoing major lung resections however it often resolves spontaneously In 8 of cases air leaks can persist for up to 5-7 days post-surgery and are associated with a higher risk of complications such as prolonged chest tube duration increased incidence of postoperative infections and higher medical and non-medical costs Sealants are non-invasive medical devices that help reduce or eliminate air leaks and bleeding A recent study showed an increased risk of air leaks in patients undergoing segmentectomies compared to lobar resections this study is designed to evaluate the efficacy of intraoperative use of Polymeric Hydrogel matrix in achieving aerostasis during anatomical segmental pulmonary resections via VATS or RATS compared to patients receiving standard of care All patients meet the eligibility criteria and successfully undergo a minimally invasive segmentectomy will undergo intraoperative evaluation of alveolar air leaks Those with moderate air leaks 30-60 mlrespiratory act measured at the Ventilation Mechanical Test which consists in 1 minute volumetric ventilation with a constant flow and a peak pressure of 22 cmH2O 12 respiratory rates per minute and a positive end-expiratory pressure PEEP of 5 cmH2O will be randomized to receive Polymeric Hydrogel matrix or no further treatmentThe primary endpoint is to evaluate the efficacy in reducing postoperative air leaks secondary to the intraoperative application of Polymeric Hydrogel matrix measured in days from the first postoperative day to the last day the air leaks are detected compared to a control group receiving standard of careThe secondary endpoints include the evaluation of the postoperative permanence of chest tube total length of hospital stay medical and non-medical costs and postoperative complications up to 40 days of follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None