Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518707
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-18
Brief Title:
Intraoperative Diaphragmatic Neuromodulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Intraoperative Diaphragmatic Neuromodulation on Postoperative Complications in Neurosurgical Patients A Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This prospective single-center randomized controlled clinical trial aims to investigate the impact of intraoperative phrenic nerve stimulation ie diaphragmatic neuromodulation on postoperative complications in neurosurgical patients The primary objective is to assess the effect on postoperative brain injury including the development of delirium and changes in biomarkers Additionally the incidence of postoperative pulmonary complications will be investigated
Detailed Description:
BackgroundPostoperative complications such as delirium and pulmonary complications commonly occur in patients undergoing craniotomy In preclinical studies phrenic nerve stimulation ie diaphragmatic neuromodulation has been reported to effectively mitigate brain injury and pulmonary complications However its intraoperative administration and its impact on postoperative complications in this population are largely unknown
MethodIn this prospective single-center randomized controlled clinical trial patients receiving elective craniotomy will be screened Eligible patients will be randomly divided into three groups 1 Control group without any interventions 2 Intraoperative phrenic nerve stimulation PNS without total neuromuscular blockade Train-of-Four TOF 0 3 Intraoperative PNS with partial neuromuscular blockade TOF in the range of 1-2 Diaphragm ultrasound will be performed to assess diaphragm function before surgery and at 24 hours and 48 hours after surgery respectively Postoperative delirium will be assessed daily using the 3D-CAM and CAM-ICU within 3 days Plasma biomarkers of brain injury will also be tested at baseline 24 hours and 48 hours after surgery Pulmonary complications will be diagnosed by three independent clinicians based on laboratory tests imaging and clinical signs
Aims and HypothesisThe primary aims are to investigate the impact of intraoperative diaphragmatic neuromodulation on brain injury including the occurrence of delirium and changes in biomarkers The secondary aims are the incidence of postoperative pulmonary complications and other clinical outcomes We hypothesize that intraoperative diaphragmatic neuromodulation could reduce brain injury induced by craniotomy as well as the incidence of postoperative delirium and pulmonary complications
MethodIn this prospective single-center randomized controlled clinical trial patients receiving elective craniotomy will be screened Eligible patients will be randomly divided into three groups 1 Control group without any interventions 2 Intraoperative phrenic nerve stimulation PNS without total neuromuscular blockade Train-of-Four TOF 0 3 Intraoperative PNS with partial neuromuscular blockade TOF in the range of 1-2 Diaphragm ultrasound will be performed to assess diaphragm function before surgery and at 24 hours and 48 hours after surgery respectively Postoperative delirium will be assessed daily using the 3D-CAM and CAM-ICU within 3 days Plasma biomarkers of brain injury will also be tested at baseline 24 hours and 48 hours after surgery Pulmonary complications will be diagnosed by three independent clinicians based on laboratory tests imaging and clinical signs
Aims and HypothesisThe primary aims are to investigate the impact of intraoperative diaphragmatic neuromodulation on brain injury including the occurrence of delirium and changes in biomarkers The secondary aims are the incidence of postoperative pulmonary complications and other clinical outcomes We hypothesize that intraoperative diaphragmatic neuromodulation could reduce brain injury induced by craniotomy as well as the incidence of postoperative delirium and pulmonary complications
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