End Tidal Carbon DioxideNCT03932617
Correlation Between Changes in End-Tidal Carbon Dioxide and Stroke Volume Variation Detected by Electrical Cardiometry as A Predictor of Fluid Volume Responsiveness in Hemodynamically Unstable Patients in the Intensive Care
An observational study of End Tidal Carbon Dioxide and Cardiometry, run by Tanta University at 1 site in Egypt.
Trial summary
This study will be conducted to assess the role of end-tidal carbon dioxide (PETCO2) monitoring to predict the fluid volume responsiveness in correlation with stroke volume variation detected by electrical cardiometry in patients with hemodynamic instability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Tidal Carbon Dioxide, Cardiometry, Fluid Responsiveness
- What is being tested?
- end tidal carbon dioxide by capnography
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 31 Jan 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Tanta University Hospital at surgical intensive care unit (SICU).
Who may be able to join
- Patients who will be 18 years or older.
- Patients on mechanical ventilation in the intensive care.
- Patients developing hypotension (MABP) <65 mmHg.
Who cannot join
- Patients with organ/s failure at presentation.
- Patients with deep venous thrombosis.
- Patients with limb and pelvic fractures.
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to assess the role of end-tidal carbon dioxide (PETCO2) monitoring to predict the fluid volume responsiveness in correlation with stroke volume variation detected by electrical cardiometry in patients with hemodynamic instability.
- Conditions
- End Tidal Carbon Dioxide, Cardiometry, Fluid Responsiveness, Shock
- Being tested
- end tidal carbon dioxide by capnography
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
end tidal carbon dioxide by capnographyDevice
Moreover, since PETCO2 is mainly determined by tissue CO2 production (VCO2), alveolar ventilation and CO, when stable metabolic conditions are assumed and minute ventilation is kept constant, acute changes in PETCO2 have been shown to correlate strongly with changes in CO.
Thus, PETCO2 has been suggested as a simple economic and noninvasive alternative for continuous assessment of CO in different shock states.
| Study group | Role | What they receive |
|---|---|---|
| fluid responders | Not described Receives: Device: end tidal carbon dioxide by capnography | |
| fluid non responders | Not described Receives: Device: end tidal carbon dioxide by capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of sensitivity and specificity of end tidal carbon dioxide monitoring in predicting fluid responsiveness in correlation with stoke volume variation detected by cardiometry
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Jun 2019
- Primary completion1 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Tidal Carbon DioxideStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elbaiomy Abo-elkhier, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932617
- Sponsor's protocol ID
- 32880/01/19
- Status last verified
- Feb 2021
- First submitted
- 28 Apr 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Changes in End-Tidal Carbon Dioxide and Stroke Volume Variation Detected by Electrical Cardiometry as A Predictor of Fluid Volume Responsiveness in Hemodynamically Unstable Patients in the Intensive Care
- ClinicalTrials.gov ID
- NCT03932617
- Acronym / sponsor ID
- 32880/01/19
- Conditions
- End Tidal Carbon Dioxide, Cardiometry, Fluid Responsiveness, Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 1 May 2019 (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.
This study will be conducted to assess the role of end-tidal carbon dioxide (PETCO2) monitoring to predict the fluid volume responsiveness in correlation with stroke volume variation detected by electrical cardiometry in patients with hemodynamic instability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluid responders | – | Device: end tidal carbon dioxide by capnography |
| fluid non responders | – | Device: end tidal carbon dioxide by capnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Tanta University Hospital at surgical intensive care unit (SICU).
Key inclusion criteria (3 listed)
- Patients who will be 18 years or older.
- Patients on mechanical ventilation in the intensive care.
- Patients developing hypotension (MABP) <65 mmHg.
Key exclusion criteria (4 listed)
- Patients with organ/s failure at presentation.
- Patients with deep venous thrombosis.
- Patients with limb and pelvic fractures.
- Pregnant 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 |
|---|---|---|
| end tidal carbon dioxide by capnographyMoreover, since PETCO2 is mainly determined by tissue CO2 production (VCO2), alveolar ventilation and CO, when stable metabolic conditions are assumed and minute ventilation is kept constant, acute changes in PETCO2 have been shown to correlate strongly with changes in CO. Thus, PETCO2 has been suggested as a simple economic and noninvasive alternative for continuous assessment of CO in different shock states. | Device | fluid non responders, fluid responders |
Primary outcome
Assessment of sensitivity and specificity of end tidal carbon dioxide monitoring in predicting fluid responsiveness in correlation with stoke volume variation detected by cardiometry
Time frame: 24 hour
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 21 Feb 2021.
- Individual participant dataSharing planned: Yes
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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?
An observational study of End Tidal Carbon Dioxide and Cardiometry, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 4 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 21 Feb 2021. 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 Egypt. 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?
Assessment of sensitivity and specificity of end tidal carbon dioxide monitoring in predicting fluid responsiveness in correlation with stoke volume variation detected by cardiometry (time frame: 24 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 21 Feb 2021.