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

Low Flow Anesthesia Clinical Trial

Official title:

Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097806
• Other study ID #: Basaksehir Çam and Sakura
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: Basaksehir Çam & Sakura City Hospital
• Contact: Hazal Ozsagiroglu
• Phone: +905387284700
• Email: hazalozsagiroglu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Gender: All
• Age group: 2 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Flow Anesthesia

Intervention

Other:
• low and high flow
low and high flow anesthesia are both being used. The effects of different gas flows will be evaluated.

Locations

Country	Name	City	State
Turkey	Basaksehir Cam and Sakura City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Çam & Sakura City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COHb levels	COHb values will be measured in arterial blood gas samples at different fresh gas flow 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
Secondary	extubation time	the time of extubation	at the time that patient is extubated up to 24 hours
Secondary	body temperature	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
Secondary	bleeding	Total amount of bleeding during the first 24 hours	24 hours
Secondary	vasoactive inotrope score (VIS)	VIS at the end of the operation	postoperative first hour