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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05264766
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 8.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Heart; Surgery, Heart, Functional Disturbance as Result	Device: Cooling helmet on; Device: Cooling helmet off	N/A

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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium
• Actual Study Start Date: Oct 1, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cooling helmet on Cooling helmet on means there was circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on	Device: Cooling helmet on; Cooling helmet with circulating cold water
Active Comparator: Cooling helmet off Cooling helmet on means there was no circulating cold water inside the helmet, put after induction during cardiopulmonary bypass on	Device: Cooling helmet off; Cooling helmet without circulating cold water

Outcome Measures

Primary Outcome Measures

1. Neuron-specific enolase [6 hours post cardiopulmonary bypass off]

   Neuronal injury marker. The higher the value, the worse the outcome

2. Confusion Assessment Method - Intensive Care Unit (CAM-ICU) [Changes of CAM-ICU from 12 hours to 24 hours postoperative]

   Tools to assess delirium. The higher the errors, the worse the outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient undergoing their first open heart surgery using cardiopulmonary bypass

• Age ≥18 year-old

• Patient with American Society of Anesthesiologists (ASA) III

• Patient with Glasgow Coma Scale (GCS) 15, fully aware and oriented

• Patient fluent in Indonesia

Exclusion Criteria:

• Patients did not give consent to participate in the study

• Patients with central nervous system disease (stroke, intracranial tumor)

• Patients with psychiatric problem (schizophrenia, depression)

• Patients with cognitive problem

• Blind and deaf patient

• Patient on psychotrophic or narcotics medication

Drop out criteria

• Surgery without cardiopulmonary bypass

• Patient demise after surgery

• Patients decided to refrain from the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Central National Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamad Prakoso Adji, Principal Investigator, Indonesia University
• ClinicalTrials.gov Identifier: NCT05264766
• Other Study ID Numbers: IndonesiaUAnes333
• First Posted: Mar 3, 2022
• Last Update Posted: Mar 3, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamad Prakoso Adji, Principal Investigator, Indonesia University: cooling helmet; neuron specific enolase; delirium; open heart surgery

Study Results

No Results Posted as of Mar 3, 2022