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

NCT06097806 | Recruiting

• 1 other identifier: Başakşehir Çam and Sakura
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Flow Anesthesia; High Flow Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• extubation time

  at the time that patient is extubated up to 24 hours

• 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

• bleeding

  24 hours

• vasoactive inotrope score (VIS)

  postoperative first hour

Study Arms (2)

Low-flow anesthesia group

In this group, ventilation parameters is adjusted to have fresh gas flow/minute ventilation ratio below 0.5

Other: low and high flow

High-flow anesthesia group

In this group, ventilation parameters is adjusted to have fresh gas flow/minute ventilation ratio above 1.0

Other: low and high flow

Interventions

low and high flow OTHER

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

High-flow anesthesia group; Low-flow anesthesia group

Eligibility Criteria

• Age: 2 Months - 7 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected among the patients who will undergo cardiac surgery at Basaksehir Cam and Sakura City Hospital Pediatric Cardiovascular Surgery Clinic.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Hazal Ozsagiroglu

CONTACT

+905387284700; hazalozsagiroglu@gmail.com

Selin Saglam

CONTACT

+905557198756; selinsaglams@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 24, 2023
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

TU (1)