VentilationETCO2NCT04281589
End-tidal Carbon Dioxide Monitoring in Low Tidal Volume Ventilation
A study testing if the ventilation parameter caused desaturation or hypercapnia we will change the parameter in people with Ventilation and End-Tidal Carbon Dioxide, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
In cases where there is no ventilation-perfusion problem, the end-tidal carbon dioxide (ETCO2) value is closely associated with partial arterial carbon dioxide pressure (PaCO2); therefore, the PaCO2 value can be estimated using ETCO2 measurements in patients without significant cardiopulmonary disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation, End-Tidal Carbon Dioxide
- What is being tested?
- if the ventilation parameter caused desaturation or hypercapnia we will change the parameter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2019to 23 Jan 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification 1, 2 risk group
- Head and neck surgery under general anesthesia lasting more than 120 minutes and who progressed normotensive.
Who cannot join
- Cardiac disease
- Pulmonary disease
- Obese patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Döndü Genç Moralar
Istanbul, Istanbul, Turkey, 34000
About this study
Official title: Does End-Tidal Carbon Dioxide Value Show The Adequacy Of Ventilation In Low Tidal Volume Ventilation
In cases where there is no ventilation-perfusion problem, the end-tidal carbon dioxide (ETCO2) value is closely associated with partial arterial carbon dioxide pressure (PaCO2); therefore, the PaCO2 value can be estimated using ETCO2 measurements in patients without significant cardiopulmonary disorders. The aim of the investigator's study is to evaluate the reliability of pulmonary ventilation monitoring with ETCO2 value and to investigate at what tidal volume values ETCO2 monitoring provides reliable information.
Read the detailed description
The patients were grouped as follows: Group 1, if the tidal volume is 4 ml/kg; Group 2, if TV=6 ml/kg; Group 3, if TV=8 ml/kg; and Group 4, if TV=10 ml/kg. It was determined how many breaths per minute (minute ventilation) would be given with tidal volume x respiratory rate=6 L. The patients were ventilated with the same ventilation parameters for 30 minutes and then arterial blood gas analysis was performed. Arterial blood gas was collected at t1 for group 1, t2 for group 2, t3 for group 3, and t4 for group 4. The ETCO2 value, Peak pressure (Ppeak), Plateau pressure (Pplato), mean airway pressure (Pmean) values were recorded at the time of arterial blood gas collection. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), peak heart rate (PHR) values were evaluated. The patients with a mean arterial pressure of less than 65 mmHg were excluded from the study. Partial arterial oxygen pressure (PaO2), partial arterial carbon dioxide pressure (PaCO2), oxygen saturation (SO2) values were recorded from the arterial blood gas analysis. P (a-ET) CO2 gradient value was calculated.
The groups were compared, in each patient, under the same conditions, when the different tidal volume was applied, how the ETCO2 monitorization, PaO2 values and hence the P (a-ET) CO2 gradient changed.
- Conditions
- Ventilation, End-Tidal Carbon Dioxide
- Being tested
- if the ventilation parameter caused desaturation or hypercapnia we will change the parameter
- Keywords
- End-Tidal Carbon Dioxide, P(a-ET)CO2 gradient, ETCO2, low tidal volüm, mekanical Ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
if the ventilation parameter caused desaturation or hypercapnia we will change the parameterOther
we will increased fi02
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | tidal volüm is 4 ml/kg Receives: Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parameter |
| Group 2 | Experimental | tidal volüm is 6 ml/kg Receives: Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parameter |
| Group 3 | Experimental | tidal volüm is 8 ml/kg Receives: Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parameter |
| Group 4 | Experimental | tidal volüm is 10 ml/kg Receives: Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
P (a-ET) CO2 gradient
The groups were compared, in each patient, under the same conditions, when the different tidal volume was applied, how the ETCO2 monitorization, PaCO2 values and hence the P (a-ET) CO2 gradient changed.
Measured: 120 minutes
Secondary outcomes (1)
Partial arterial oxygen pressure (PaO2)
Partial arterial oxygen pressure (PaO2) were recorded from the arterial blood gas analysis
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start7 May 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VentilationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281589
- Sponsor's protocol ID
- dondum
- Acronym
- ETCO2
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 24 Feb 2020
- 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 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does End-Tidal Carbon Dioxide Value Show The Adequacy Of Ventilation In Low Tidal Volume Ventilation
- ClinicalTrials.gov ID
- NCT04281589
- Acronym / sponsor ID
- ETCO2 / dondum
- Conditions
- Ventilation, End-Tidal Carbon Dioxide
- Keywords
- End-Tidal Carbon Dioxide, P(a-ET)CO2 gradient, ETCO2, low tidal volüm, mekanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 7 May 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 24 Feb 2020 (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.
In cases where there is no ventilation-perfusion problem, the end-tidal carbon dioxide (ETCO2) value is closely associated with partial arterial carbon dioxide pressure (PaCO2); therefore, the PaCO2 value can be estimated using ETCO2 measurements in patients without significant cardiopulmonary disorders. The aim of the investigator's study is to evaluate the reliability of pulmonary ventilation monitoring with ETCO2 value and to investigate at what tidal volume values ETCO2 monitoring provides reliable information.
Detailed description
The patients were grouped as follows: Group 1, if the tidal volume is 4 ml/kg; Group 2, if TV=6 ml/kg; Group 3, if TV=8 ml/kg; and Group 4, if TV=10 ml/kg. It was determined how many breaths per minute (minute ventilation) would be given with tidal volume x respiratory rate=6 L. The patients were ventilated with the same ventilation parameters for 30 minutes and then arterial blood gas analysis was performed. Arterial blood gas was collected at t1 for group 1, t2 for group 2, t3 for group 3, and t4 for group 4. The ETCO2 value, Peak pressure (Ppeak), Plateau pressure (Pplato), mean airway pressure (Pmean) values were recorded at the time of arterial blood gas collection. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), peak heart rate (PHR) values were evaluated. The patients with a mean arterial pressure of less than 65 mmHg were excluded from the study. Partial arterial oxygen pressure (PaO2), partial arterial carbon dioxide pressure (PaCO2), oxygen saturation (SO2) values were recorded from the arterial blood gas analysis. P (a-ET) CO2 gradient value was calculated.
The groups were compared, in each patient, under the same conditions, when the different tidal volume was applied, how the ETCO2 monitorization, PaO2 values and hence the P (a-ET) CO2 gradient changed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- sequential
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parametertidal volüm is 4 ml/kg |
| Group 2 | Experimental | Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parametertidal volüm is 6 ml/kg |
| Group 3 | Experimental | Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parametertidal volüm is 8 ml/kg |
| Group 4 | Experimental | Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parametertidal volüm is 10 ml/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification 1, 2 risk group
- Head and neck surgery under general anesthesia lasting more than 120 minutes and who progressed normotensive.
Key exclusion criteria (3 listed)
- Cardiac disease
- Pulmonary disease
- Obese patients
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 |
|---|---|---|
| if the ventilation parameter caused desaturation or hypercapnia we will change the parameterwe will increased fi02 | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
P (a-ET) CO2 gradient
Time frame: 120 minutes
The groups were compared, in each patient, under the same conditions, when the different tidal volume was applied, how the ETCO2 monitorization, PaCO2 values and hence the P (a-ET) CO2 gradient changed.
1 secondary outcome
Partial arterial oxygen pressure (PaO2)
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing if the ventilation parameter caused desaturation or hypercapnia we will change the parameter in people with Ventilation and End-Tidal Carbon Dioxide, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 3 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: finished, as of the sponsor's last update on 24 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P (a-ET) CO2 gradient (time frame: 120 minutes). 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 24 Feb 2020.