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

October 18, 2023 updated by: Selin Saglam, Basaksehir Cam & Sakura Şehir Hospital

Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Basaksehir Cam and Sakura City Hospital
        • Contact:
        • Principal Investigator:
          • Hazal Ozsagiroglu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
low and high flow anesthesia are both being used. The effects of different gas flows will be evaluated.
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
low and high flow anesthesia are both being used. The effects of different gas flows will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COHb levels
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
extubation time
Time Frame: at the time that patient is extubated up to 24 hours
the time of extubation
at the time that patient is extubated up to 24 hours
body temperature
Time Frame: 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
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
Time Frame: 24 hours
Total amount of bleeding during the first 24 hours
24 hours
vasoactive inotrope score (VIS)
Time Frame: postoperative first hour
VIS at the end of the operation
postoperative first hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basaksehir Cam & Sakura Şehir Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Başakşehir Çam and Sakura

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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