Optimal Sweep Gas FlowNCT06013189
Re-Adjustment of Sweep Gas Flow to the During the Rewarming Period of the Cardiopulmonary Bypass
An observational study of Optimal Sweep Gas Flow and Determination of Optimal Sweep Gas Flow for Different Phases of Cardiopulmonary Bypass, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators designed this prospective observational study with the theory that alkalosis caused by decreased CO2 solubility due to temperature increase during the rewarming period of the Cardiopulmonary Bypass could be prevented by reducing the sweep gas flow during the rewarming period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optimal Sweep Gas Flow, Determination of Optimal Sweep Gas Flow for Different Phases of Cardiopulmonary Bypass
- What is being tested?
- Gas Flow Adjustment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2023to Nov 2034
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age scheduled for elective CPB surgery
Who may be able to join
- Patients over 18 years of age
- Elective CPB surgery
Who cannot join
- Patients undergoing minimally invasive surgery
- Patients undergoing robotic cardiac surgery,
- Patients undergoing deep hypothermia,
- Patients undergoing total circulatory arrest,
- Patients whose FiO2 requirement is high that cannot be applied to target gas flow
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acıbadem Altunizade Hastanesi İstanbul
Istanbul, Altunizade
Melis Tosun, MD, 00905356694002, melistosun@gmail.com
About this study
Official title: Re-Adjustment of Sweep Gas Flow to the During the Rewarming Period of the Cardiopulmonary Bypass to Prevent Alkalosis
The investigators designed this prospective observational study with the theory that alkalosis caused by decreased CO2 solubility due to temperature increase during the rewarming period of the Cardiopulmonary Bypass could be prevented by reducing the sweep gas flow during the rewarming period.
- Conditions
- Optimal Sweep Gas Flow, Determination of Optimal Sweep Gas Flow for Different Phases of Cardiopulmonary Bypass
- Being tested
- Gas Flow Adjustment
- Keywords
- sweep gas flow, rewarming, cardiopulmonary bypass, alkalosis
- Medical subject headings
- Alkalosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gas Flow AdjustmentOther
Decreased gas flow causes PaCO2 to elevate and prevents alkalosis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Sweep Gas Flow did not changed (1.35 L/m2/min) | |
| Group 2 | Sweep Gas Flow decreased during rewarming (1.2 L/m2/min) Receives: Other: Gas Flow Adjustment | |
| Group 3 | Sweep Gas Flow decreased during rewarming (1 L/m2/min) Receives: Other: Gas Flow Adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial pH lever lower than 7.30
maintaining physiological pH
Measured: during the cardiopulmonary bypass and postoperative 24th hour
Secondary outcomes (1)
rSO2 20% below initial value
observing the rSO2 of brain during rewarming period
Measured: during the cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start7 Aug 2023
- Primary completion1 Nov 2023 (estimated)
- Study completionNov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optimal Sweep Gas FlowStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melis Tosun, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013189
- Sponsor's protocol ID
- ATADEK 2019-19/21
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-Adjustment of Sweep Gas Flow to the During the Rewarming Period of the Cardiopulmonary Bypass to Prevent Alkalosis
- ClinicalTrials.gov ID
- NCT06013189
- Acronym / sponsor ID
- ATADEK 2019-19/21
- Conditions
- Optimal Sweep Gas Flow, Determination of Optimal Sweep Gas Flow for Different Phases of Cardiopulmonary Bypass
- Keywords
- sweep gas flow, rewarming, cardiopulmonary bypass, alkalosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- Nov 2034 (estimated)
- First posted
- 28 Aug 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.
The investigators designed this prospective observational study with the theory that alkalosis caused by decreased CO2 solubility due to temperature increase during the rewarming period of the Cardiopulmonary Bypass could be prevented by reducing the sweep gas flow during the rewarming period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Sweep Gas Flow did not changed (1.35 L/m2/min) |
| Group 2 | – | Other: Gas Flow AdjustmentSweep Gas Flow decreased during rewarming (1.2 L/m2/min) |
| Group 3 | – | Other: Gas Flow AdjustmentSweep Gas Flow decreased during rewarming (1 L/m2/min) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age scheduled for elective CPB surgery
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Elective CPB surgery
Key exclusion criteria (5 listed)
- Patients undergoing minimally invasive surgery
- Patients undergoing robotic cardiac surgery,
- Patients undergoing deep hypothermia,
- Patients undergoing total circulatory arrest,
- Patients whose FiO2 requirement is high that cannot be applied to target gas flow
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 |
|---|---|---|
| Gas Flow AdjustmentDecreased gas flow causes PaCO2 to elevate and prevents alkalosis | Other | Group 2, Group 3 |
Primary outcome
Arterial pH lever lower than 7.30
Time frame: during the cardiopulmonary bypass and postoperative 24th hour
maintaining physiological pH
1 secondary outcome
rSO2 20% below initial value
Time frame: during the cardiopulmonary bypass
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
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.
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 Optimal Sweep Gas Flow and Determination of Optimal Sweep Gas Flow for Different Phases of Cardiopulmonary Bypass, run by Acıbadem Atunizade 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: looking for participants now, as of the sponsor's last update on 28 Aug 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melis Tosun, MD (00905356694002, melistosun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial pH lever lower than 7.30 (time frame: during the cardiopulmonary bypass and postoperative 24th hour). 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 28 Aug 2023.