Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels and Postoperative Patient Outcomes in Pediatric Cardiovascular Surgery

Recruiting

• Conditions: High Flow Anesthesia; Low Flow Anesthesia
• Interventions: Other: low and high flow

• Registration Number: NCT06097806
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

Brief Summary

Low flow anesthesia; It is an anesthesia practice in which, after absorbing at least 50% of the exhaled air and carbon dioxide (CO2) using a semi-closed rebreathing system, the unused anesthetic gases are mixed with a certain amount of fresh gas and then completely or partially returned to the patient in the next inspiration. Theoretically, when low flow anesthesia is compared to high or normal flow anesthesia; it is known to have advantages such as using less inhalation agent, preserving mucociliary activity, preventing microatelectasis, preserving the amount of moisture, and reducing temperature loss.

In studies conducted in different fresh gas flows, it has been observed that CO, which is thought to accumulate in the body by rebreathing in a closed circuit, increases as a result of the chemical interaction and dry CO2 absorbent. However, there is no evidence in these studies that low-flow anesthesia increases CO accumulation and alters hemodynamics.

In our clinic, low-flow and high-flow anesthesia technics are both being used. In this study, we aimed to evaluate the effects of high- and low-flow sevoflurane anesthesia applied with a closed system on perioperative carboxyhemoglobin (COHb) levels and hemodynamic system in pediatric cardiovascular surgery cases.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-18
• Last Update Posted: 2024-05-21
• Study Start: 2024-06-01
• Primary Completion: 2024-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients between the ages of 2 months and 7 years undergoing elective cardiac surgery
• American Society of Anesthesiology (ASA) score II ve III patients

Exclusion Criteria

• Patients undergoing emergency surgery
• Patients who need mechanical ventilation or any respiratory support before the operation
• Patients with left to right shunt
• cyanotic patients
• Patients younger than 2 months and older than 7 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-flow anesthesia group	low and high flow	In this group, ventilation parameters is adjusted to have fresh gas flow/minute ventilation ratio below 0.5
High-flow anesthesia group	low and high flow	In this group, ventilation parameters is adjusted to have fresh gas flow/minute ventilation ratio above 1.0

Primary Outcome Measures

Name	Time	Method
COHb levels	at the 30th minute of the surgery, at the beginning of cardiopulmonary bypass, at the time of chest closure, at the time of intensive care unit admission	COHb values will be measured in arterial blood gas samples at different fresh gas flow levels.

Secondary Outcome Measures

Name	Time	Method
extubation time	at the time that patient is extubated up to 24 hours	the time of extubation
vasoactive inotrope score (VIS)	postoperative first hour	VIS at the end of the operation
body temperature	at the 30th minute of the surgery, at the beginning of cardiopulmonary bypass, at the time of chest closure, at the time of intensive care unit admission	body temperature
bleeding	24 hours	Total amount of bleeding during the first 24 hours

Trial Locations

Locations (1)

Basaksehir Cam and Sakura City Hospital; 🇹🇷 Istanbul, Turkey