NCT05264766

The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery

The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery

Detailed description

Subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. Blood sample from CVC were obtained to assess NSE preoperative. After induction, cooling helmet with circulating cold water were placed on patients group A and without circulating cold water on group B. Blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess NSE postoperative. Delirium was assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU)

Conditions

• Heart; Surgery, Heart, Functional Disturbance as Result

Interventions

Type	Name	Description
DEVICE	Cooling helmet on	Cooling helmet with circulating cold water
DEVICE	Cooling helmet off	Cooling helmet without circulating cold water

Timeline

• Start date: 2021-10-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2022-03-03
• Last updated: 2022-03-03

Locations

1 site across 1 country: Indonesia