Assessing The Effects Of Mild And Moderate Hypothermia On The Cerebral Oxymetery In Acyanotic Congenital Heart Disease Under The Cardiopulmonary Bypass

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201217049741N1

Enrollment

Registered

2021-01-10

Start date

2021-01-09

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Acyanotic heart disease.

Interventions

Intervention 1: Intervention group: Patients in the mild hypothermia group (32 ° C) are treated as follows. The nasopharyngeal temperature will be maintained above 35 degrees for the time before the o

Eligibility

Sex/Gender

All

Age

1 Days to 14 Years

Inclusion criteria

Inclusion criteria: Children 1 day to 14 years old undergoing surgery for Acyanotic congenital heart disease with pulmonary heart bypass Children weighing 5 to 20 kg No history of neurological diseases No hepatic or renal insufficiency (creatinine above 2 mg / dL) No preoperative anemia No history of preoperative cardiopulmonary resuscitation Parents' consent to participate in the research project

Exclusion criteria

Exclusion criteria: Hemodynamic instability Emergency heart surgery Lower the temperature during operation to below the desired temperature

Design outcomes

Primary

Measure	Time frame
Cerebral oxygenation. Timepoint: 1- At the time after induction of anesthesia (baseline value), 2- At the time of cooling up to 34 degrees Celsius, 3- At the lowest level of cooling (first group 32 degrees Celsius), (second group 28 degrees Celsius), 4 - At the time of reheating (above 34 degrees Celsius), 5-after CPB. Method of measurement: Based on the amount of INVOS.;Blood lactate. Timepoint: 1- At the time after induction of anesthesia (baseline value), 2- At the time of cooling up to 34 degrees Celsius, 3- At the lowest level of cooling (first group 32 degrees Celsius), (second group 28 degrees Celsius), 4 - At the time of reheating (above 34 degrees Celsius), 5-after CPB. Method of measurement: Laboratory kits.;Incidence of neurological complications. Timepoint: From postoperative time to discharge. Method of measurement: Based on patient records.;Average intubation time. Timepoint: From the time of surgery to Extubation. Method of measurement: Based on patient records.	—

Measure

Time frame

Cerebral oxygenation. Timepoint: 1- At the time after induction of anesthesia (baseline value), 2- At the time of cooling up to 34 degrees Celsius, 3- At the lowest level of cooling (first group 32 degrees Celsius), (second group 28 degrees Celsius), 4 - At the time of reheating (above 34 degrees Celsius), 5-after CPB. Method of measurement: Based on the amount of INVOS.;Blood lactate. Timepoint: 1- At the time after induction of anesthesia (baseline value), 2- At the time of cooling up to 34 degrees Celsius, 3- At the lowest level of cooling (first group 32 degrees Celsius), (second group 28 degrees Celsius), 4 - At the time of reheating (above 34 degrees Celsius), 5-after CPB. Method of measurement: Laboratory kits.;Incidence of neurological complications. Timepoint: From postoperative time to discharge. Method of measurement: Based on patient records.;Average intubation time. Timepoint: From the time of surgery to Extubation. Method of measurement: Based on patient records.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehran Jafarian

Shahid Rajaei Cardiovascular Hospital, Tehran

mehran.jafarian1369@gmail.com+98 21 23921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026