Low Flow AnesthesiaNCT06097806
Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels and Postoperative Patient Outcomes in Pediatric Cardiovascular Surgery
An observational study of Low Flow Anesthesia and High Flow Anesthesia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 2 months to 7 years
- Conditions the study is for
- Low Flow Anesthesia, High Flow Anesthesia
- What is being tested?
- low and high flow
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 7 years
- All sexes
- Child
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.
Who may be able to join
- Patients between the ages of 2 months and 7 years undergoing elective cardiac surgery
- American Society of Anesthesiology (ASA) score II ve III patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Basaksehir Cam and Sakura City Hospital
Istanbul
Selin Sağlam, selinsaglam@gmail.com
Hazal Ozsagiroglu
About this study
Official title: 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.
- Conditions
- Low Flow Anesthesia, High Flow Anesthesia
- Being tested
- low and high flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low and high flowOther
low and high flow anesthesia are both being used. The effects of different gas flows will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Low-flow anesthesia group | In this group, ventilation parameters is adjusted to have fresh gas flow/minute ventilation ratio below 0.5 Receives: 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 Receives: Other: low and high flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
COHb levels
COHb values will be measured in arterial blood gas samples at different fresh gas flow levels.
Measured: 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
the time of extubation
Measured: at the time that patient is extubated up to 24 hours
body temperature
body temperature
Measured: 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
Total amount of bleeding during the first 24 hours
Measured: 24 hours
vasoactive inotrope score (VIS)
VIS at the end of the operation
Measured: postoperative first hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Jun 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Flow AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Selin Saglam, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097806
- Sponsor's protocol ID
- Başakşehir Çam and Sakura
- Status last verified
- May 2024
- First submitted
- 6 Oct 2023
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels
- ClinicalTrials.gov ID
- NCT06097806
- Acronym / sponsor ID
- Başakşehir Çam and Sakura
- Conditions
- Low Flow Anesthesia, High Flow Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-flow anesthesia group | – | Other: low and high flowIn this group, ventilation parameters is adjusted to have fresh gas flow/minute ventilation ratio below 0.5 |
| High-flow anesthesia group | – | Other: low and high flowIn this group, ventilation parameters is adjusted to have fresh gas flow/minute ventilation ratio above 1.0 |
Who may qualify
- Ages
- 2 months to 7 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Patients between the ages of 2 months and 7 years undergoing elective cardiac surgery
- American Society of Anesthesiology (ASA) score II ve III patients
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low and high flowlow and high flow anesthesia are both being used. The effects of different gas flows will be evaluated. | Other | High-flow anesthesia group, Low-flow anesthesia group |
Primary outcome
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.
4 secondary outcomes
extubation time
Time frame: 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
bleeding
Time frame: 24 hours
vasoactive inotrope score (VIS)
Time frame: postoperative first hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Flow Anesthesia and High Flow Anesthesia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hazal Ozsagiroglu (+905387284700, hazalozsagiroglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.