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

Sponsor
Basaksehir Cam & Sakura Şehir Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06097806
Collaborator
(none)
40
1
24
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: low and high flow

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. extubation time [at the time that patient is extubated up to 24 hours]

    the time of extubation

  2. 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

  3. bleeding [24 hours]

    Total amount of bleeding during the first 24 hours

  4. vasoactive inotrope score (VIS) [postoperative first hour]

    VIS at the end of the operation

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months to 7 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Basaksehir Cam and Sakura City Hospital Istanbul Turkey

Sponsors and Collaborators

  • Basaksehir Cam & Sakura Şehir Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Selin Saglam, Specialist, Basaksehir Cam & Sakura Şehir Hospital
ClinicalTrials.gov Identifier:
NCT06097806
Other Study ID Numbers:
  • Başakşehir Çam and Sakura
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 24, 2023