Effect of a Cooling Helmet on Postoperative Cognitive Dysfunction in Adults Undergoing Open-Heart Surgery (HELMET-POCD)
Effectiveness of Cooling Helmet Use on the Incidence of Postoperative Cognitive Dysfunction in Adult Patients Undergoing Open-Heart Surgery: A Single-Blind Randomized Clinical Trial
Postoperative cognitive dysfunction, or POCD, is a decline in thinking, memory, attention, or executive function that may occur after surgery and anesthesia. Patients undergoing open heart surgery with cardiopulmonary bypass may have a higher risk of POCD because of changes in blood flow, inflammation, microemboli, and changes in brain oxygen supply during surgery.
Cooling the head during open heart surgery may help protect the brain by reducing brain metabolism, oxygen demand, inflammation, and cellular injury. A cooling helmet is a non-invasive device placed on the patient's head during surgery. In this study, the cooling helmet is used to circulate cold water around the scalp during cardiopulmonary bypass.
The purpose of this study is to determine whether the use of a cooling helmet reduces the incidence of POCD in adult patients undergoing open heart surgery with cardiopulmonary bypass. The main question is whether patients who receive head cooling with a cooling helmet have a lower rate of POCD compared with patients who wear the same helmet with room-temperature water circulation.
Descripción general del estudio
Estado
Descripción detallada
This study is a single-blind randomized controlled trial evaluating the use of a cooling helmet as an additional neuroprotective strategy during open heart surgery with cardiopulmonary bypass. Postoperative cognitive dysfunction is an important neurologic complication after cardiac surgery and may affect memory, attention, executive function, recovery, independence, and quality of life.
During cardiopulmonary bypass, the brain may be exposed to several potential mechanisms of injury, including reduced cerebral perfusion, microemboli, systemic inflammation, changes in oxygen delivery, and temperature changes during cooling and rewarming. Mild hypothermia has been proposed as a neuroprotective strategy because lower temperature can reduce cerebral metabolic demand, oxygen consumption, excitotoxicity, inflammatory response, free radical production, and neuronal apoptosis.
The cooling helmet used in this study is a non-invasive head-cooling device designed to provide more even and continuous cooling than conventional external ice application. The device consists of water-filled tubing arranged around the head and connected to a pump and cooling box. In the intervention group, cold water is circulated through the helmet during cardiopulmonary bypass. In the control group, room-temperature water is circulated through the same helmet. Participants are blinded to group allocation.
Cognitive function is assessed before surgery and again after surgery using neurocognitive tests that evaluate memory, attention, and executive function. These include the Rey Auditory Verbal Learning Test, Digit Span Forward and Backward, and Trail Making Test A and B. POCD is determined by comparing postoperative neurocognitive performance with baseline performance before surgery.
Intraoperative monitoring includes standard anesthetic monitoring, cerebral regional oxygen saturation monitoring using near-infrared spectroscopy, and temperature monitoring using nasopharyngeal and rectal temperature probes. The study also observes potential side effects related to the cooling helmet, including cold-related skin injury and shivering.
This study is designed to clarify whether localized head cooling with a cooling helmet can reduce postoperative cognitive dysfunction in adults undergoing open heart surgery with cardiopulmonary bypass.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
DKI Jakarta
-
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Dr. Cipto Mangunkusumo National Central General Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Scheduled to undergo open heart surgery using cardiopulmonary bypass.
- Age older than 18 years.
- American Society of Anesthesiologists (ASA) physical status III or IV.
- Fully conscious with Glasgow Coma Scale score of 15.
- Able to communicate in Indonesian.
Exclusion Criteria:
- Refusal to participate in the study.
- History of central nervous system disorder, such as stroke or intracranial tumor.
- History of psychiatric disorder.
- Severe cognitive impairment.
- Use of psychotropic or narcotic drugs.
- Blindness or hearing impairment.
- Uncooperative patient.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cooling Helmet On
Participants assigned to this group wore a cooling helmet during open heart surgery with cardiopulmonary bypass.
Cold water was circulated through the helmet as a localized head-cooling intervention.
|
A non-invasive head-cooling device placed on the participant's head during open heart surgery with cardiopulmonary bypass.
The device consists of water-filled tubing connected to a pump and cooling box.
In this intervention, cold water was circulated through the helmet to provide localized head cooling during cardiopulmonary bypass.
Otros nombres:
|
|
Comparador falso: Cooling Helmet Off
Participants assigned to this group wore the same cooling helmet during open heart surgery with cardiopulmonary bypass, but room-temperature water was circulated through the helmet.
|
The same non-invasive cooling helmet device was placed on the participant's head during open heart surgery with cardiopulmonary bypass.
In this control intervention, room-temperature water was circulated through the helmet instead of cold water.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Postoperative Cognitive Dysfunction
Periodo de tiempo: From 1 day before surgery to postoperative day 7
|
Incidence of postoperative cognitive dysfunction (POCD), defined as a decline of 20% or more in at least two neurocognitive tests after surgery compared with preoperative baseline.
Neurocognitive function was assessed using the Rey Auditory Verbal Learning Test, Digit Span Forward and Backward, and Trail Making Test A and B.
|
From 1 day before surgery to postoperative day 7
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Adji MP, Hidayat JK, Heriwardito A. Neuroprotection role of cooling helmet on neuron specific enolase (NSE) and post-surgery delirium levels in open heart surgery patients: a randomized controlled trial. Anaesth Pain Intensive Care. 2022;26(5):588-594. doi:10.35975/apic.v26i5.1985.
- Motshabi-Chakane P, Mogane P, Moutlana J, Leballo-Mothibi G, Dingezweni S, Mpanya D, Tsabedze N. Contemporary Neuroprotection Strategies during Cardiac Surgery: State of the Art Review. Int J Environ Res Public Health. 2021 Dec 3;18(23):12747. doi: 10.3390/ijerph182312747.
- Soenarto RF, Hidayat JK, Eureka O, Auerkari AN. Can Near-Infrared Spectroscopy (NIRS) monitoring prevent post-operative cognitive dysfunction following open- heart surgery? J Pak Med Assoc. 2021 Feb;71(Suppl 2)(2):S10-S13.
- Sirvinskas E, Usas E, Mankute A, Raliene L, Jakuska P, Lenkutis T, Benetis R. Effects of intraoperative external head cooling on short-term cognitive function in patients after coronary artery bypass graft surgery. Perfusion. 2014 Mar;29(2):124-9. doi: 10.1177/0267659113497074. Epub 2013 Jul 22.
- Soenarto RF, Mansjoer A, Amir N, Aprianti M, Perdana A. Cardiopulmonary Bypass Alone Does Not Cause Postoperative Cognitive Dysfunction Following Open Heart Surgery. Anesth Pain Med. 2018 Dec 3;8(6):e83610. doi: 10.5812/aapm.83610. eCollection 2018 Dec.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25-07-1141
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .