Non Cardiac SurgeryNCT06962748
End-tidal Carbon Dioxide as a Non-invasive Predictor for Changes in Cardiac Output in Non-cardiac Surgery
A study testing cerebral blood flow measurment, TTE CO measurment and ETCO2 in people with Non Cardiac Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
Cardiac output (CO) is challenging to measure at the bedside. The traditional gold standard for measuring CO requires the insertion of a pulmonary artery catheter which is invasive, associated with a risk for serious complications [3],with no clinical benefits. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Cardiac Surgery
- What is being tested?
- cerebral blood flow measurment, TTE CO measurment and ETCO2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Dec 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patients age will be ranged from 18-55 years,
- ASA physical status I-II,
- General surgeries not involving the head and neck
- Orthopedic surgeries involving the lower limb
- Patients in supine posture
Who cannot join
- Those with Respiratory disease including but not limited to Pneumonia, COPD, Restrictive lung disease and ARDS
- Those with anemia.
- Patients' refusal to participate in the study.
- Thoracic surgeries.
- Morbidly obese patients.
- Significant carotid artery disease.
- Surgeries of less than 2-hour duration.
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac output (CO) is challenging to measure at the bedside. The traditional gold standard for measuring CO requires the insertion of a pulmonary artery catheter which is invasive, associated with a risk for serious complications [3],with no clinical benefits.
The cerebral blood flow (CBF) is considered to be a proportion of total cardiac output (CO). It has been stated earlier that approximately 15% of resting CO is distributed to the brain. Therefore, the flow through the CCA might serve as a surrogate parameter for CO.
Read the detailed description
- Type of Study: Cross-sectional study
- Study Setting: Operating rooms at Ain Shams University Hospital
- Study Period : 6 months
- Study Population:
- Sampling Method: The study is a double blinded observational study that will be conducted at Ain Shams University hospitals on patients scheduled for Abdominal or lower limb surgeries. The patients will be randomly divided into two equal groups group D and group C Randomization will be done by computer-generated number lists and using opaque sealed envelopes.
- Sample Size: Using PASS 15 program for sample size calculation, setting confidence level at 95% and two-sided confidence interval width at 0.2, it is estimated that sample size of 105 patients will be needed to detect an expected Pearsons correlation coefficient of 0.7 between end-tidal carbon dioxide and cardiac output during surgery.
- Ethical Considerations: The study will be approved by the Research Ethics Committee of the Faculty of Medicine and conducted in accordance with the principles of the declaration of Helsinki. Written informed consent from all participants will be obtained.
Study Procedures:
After the patients consented and after the induction of the anesthesia, a transthoracic echocardiography will be done to measure the cardiac output, where the LVOT diameter is measured from the parasternal long axis view to calculate the radius of the LVOT, and the velocity time integral (VTI) is calculated from the apical five chamber and the apical three chamber view, and by applying the equation the cardiac output will be calculated CO= π* (LVOT radius)2* (LVOT VTI) *HR The patients will be monitored using electrocardiography, non-invasive blood pressure measurement and pulse oximetry (SpO2), general anesthesia will be induced using Propofol 2mg/Kg, Rocuronium 0.5mg/Kg and fentanyl 1ug/kg and the all the patients will be intubated with an endotracheal tube size 7 for female and 8 for males A warming blanket will be ensured to all the patients to maintain the core temperature at 36ْC For all the patients involved in the study. The patients' Cardiac output as measured before will be correlated with the carotid blood flow after scanning the carotid artery to exclude a significant lesion as measured by the following equation and the average of a three consecutive reading will be recorded, these will be repeated every 30 min. for the procedures.
π* (Carotid diameter )4/4* VTI *HR The carotid blood flow will be measured by applying a linear probe along the medial aspect of the sternocleidomastoid muscle above the common carotid artery, by applying pulsed wave, the pulse of the carotid artery will be traced and the VTI automatically calculated the machine. The patients EtCO2 will be recorded and the average of the reading over a time interval of 30 minutes will be recorded and correlated to the cardiac output as measured by both the carotid blood flow and the TTE .The blood pressure, heart rate will be monitored and recorded
- Conditions
- Non Cardiac Surgery
- Being tested
- cerebral blood flow measurment, TTE CO measurment, ETCO2
- Keywords
- ETCO2- Cardiac output-Carotid blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral blood flow measurmentDiagnostic test
measuring CO using cerebral blood flow
TTE CO measurmentDiagnostic test
measuring CO using TTE
ETCO2Diagnostic test
measure the average ETCO2 over 30 minutes period
| Study group | Role | What they receive |
|---|---|---|
| ETCO2 | Active comparator | The patients EtCO2 will be recorded and the average of the reading over a time interval of 30 minutes will be recorded and correlated to the cardiac output as measured by both the carotid blood flow and the TTE Receives: Diagnostic Test: ETCO2 |
| TTE CO | Active comparator | a transthoracic echocardiography will be done to measure the cardiac output Receives: Diagnostic Test: TTE CO measurment |
| carotid blood flow | Active comparator | The patients' Cardiac output as measured before will be correlated with the carotid blood flow after scanning the carotid artery to exclude a significant lesion as measured by the following equation and the average of a three consecutive reading will be recorded Receives: Diagnostic Test: cerebral blood flow measurment |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of ETCO2
we assume that the change in the gradient of carbon dioxide release over a time in mechanically ventilated patients may be directly proportionate to the cardiac output and could reflect it.
In the current study we will correlate the aforementioned hypothesis with the change in the cardiac output compared to the change in the carotid blood flow as revealed by the change in the cardiac output as measured by the transthoracic echocardiography.
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Jun 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Cardiac SurgeryStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham Haggag, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962748
- Sponsor's protocol ID
- FMASU R95/2025
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-tidal Carbon Dioxide as a Non-invasive Predictor for Changes in Cardiac Output in Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT06962748
- Acronym / sponsor ID
- FMASU R95/2025
- Conditions
- Non Cardiac Surgery
- Keywords
- ETCO2- Cardiac output-Carotid blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 8 May 2025 (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.
Cardiac output (CO) is challenging to measure at the bedside. The traditional gold standard for measuring CO requires the insertion of a pulmonary artery catheter which is invasive, associated with a risk for serious complications [3],with no clinical benefits.
The cerebral blood flow (CBF) is considered to be a proportion of total cardiac output (CO). It has been stated earlier that approximately 15% of resting CO is distributed to the brain. Therefore, the flow through the CCA might serve as a surrogate parameter for CO.
Detailed description
- Type of Study: Cross-sectional study
- Study Setting: Operating rooms at Ain Shams University Hospital
- Study Period : 6 months
- Study Population:
- Sampling Method: The study is a double blinded observational study that will be conducted at Ain Shams University hospitals on patients scheduled for Abdominal or lower limb surgeries. The patients will be randomly divided into two equal groups group D and group C Randomization will be done by computer-generated number lists and using opaque sealed envelopes.
- Sample Size: Using PASS 15 program for sample size calculation, setting confidence level at 95% and two-sided confidence interval width at 0.2, it is estimated that sample size of 105 patients will be needed to detect an expected Pearsons correlation coefficient of 0.7 between end-tidal carbon dioxide and cardiac output during surgery.
- Ethical Considerations: The study will be approved by the Research Ethics Committee of the Faculty of Medicine and conducted in accordance with the principles of the declaration of Helsinki. Written informed consent from all participants will be obtained.
Study Procedures:
After the patients consented and after the induction of the anesthesia, a transthoracic echocardiography will be done to measure the cardiac output, where the LVOT diameter is measured from the parasternal long axis view to calculate the radius of the LVOT, and the velocity time integral (VTI) is calculated from the apical five chamber and the apical three chamber view, and by applying the equation the cardiac output will be calculated CO= π* (LVOT radius)2* (LVOT VTI) *HR The patients will be monitored using electrocardiography, non-invasive blood pressure measurement and pulse oximetry (SpO2), general anesthesia will be induced using Propofol 2mg/Kg, Rocuronium 0.5mg/Kg and fentanyl 1ug/kg and the all the patients will be intubated with an endotracheal tube size 7 for female and 8 for males A warming blanket will be ensured to all the patients to maintain the core temperature at 36ْC For all the patients involved in the study. The patients' Cardiac output as measured before will be correlated with the carotid blood flow after scanning the carotid artery to exclude a significant lesion as measured by the following equation and the average of a three consecutive reading will be recorded, these will be repeated every 30 min. for the procedures.
π* (Carotid diameter )4/4* VTI *HR The carotid blood flow will be measured by applying a linear probe along the medial aspect of the sternocleidomastoid muscle above the common carotid artery, by applying pulsed wave, the pulse of the carotid artery will be traced and the VTI automatically calculated the machine. The patients EtCO2 will be recorded and the average of the reading over a time interval of 30 minutes will be recorded and correlated to the cardiac output as measured by both the carotid blood flow and the TTE .The blood pressure, heart rate will be monitored and recorded
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ETCO2 | Active comparator | Diagnostic Test: ETCO2The patients EtCO2 will be recorded and the average of the reading over a time interval of 30 minutes will be recorded and correlated to the cardiac output as measured by both the carotid blood flow and the TTE |
| TTE CO | Active comparator | Diagnostic Test: TTE CO measurmenta transthoracic echocardiography will be done to measure the cardiac output |
| carotid blood flow | Active comparator | Diagnostic Test: cerebral blood flow measurmentThe patients' Cardiac output as measured before will be correlated with the carotid blood flow after scanning the carotid artery to exclude a significant lesion as measured by the following equation and the average of a three consecutive reading will be recorded |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The patients age will be ranged from 18-55 years,
- ASA physical status I-II,
- General surgeries not involving the head and neck
- Orthopedic surgeries involving the lower limb
- Patients in supine posture
Key exclusion criteria (7 listed)
- Those with Respiratory disease including but not limited to Pneumonia, COPD, Restrictive lung disease and ARDS
- Those with anemia.
- Patients' refusal to participate in the study.
- Thoracic surgeries.
- Morbidly 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 |
|---|---|---|
| cerebral blood flow measurmentmeasuring CO using cerebral blood flow | Diagnostic test | carotid blood flow |
| TTE CO measurmentmeasuring CO using TTE | Diagnostic test | TTE CO |
| ETCO2measure the average ETCO2 over 30 minutes period | Diagnostic test | ETCO2 |
Primary outcome
correlation of ETCO2
Time frame: during operation
we assume that the change in the gradient of carbon dioxide release over a time in mechanically ventilated patients may be directly proportionate to the cardiac output and could reflect it. In the current study we will correlate the aforementioned hypothesis with the change in the cardiac output compared to the change in the carotid blood flow as revealed by the change in the cardiac output as measured by the transthoracic echocardiography.
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 12 Mar 2026.
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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 cerebral blood flow measurment, TTE CO measurment and ETCO2 in people with Non Cardiac Surgery, run by Ain Shams 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 5 inclusion and 7 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 12 Mar 2026. 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?
correlation of ETCO2 (time frame: during operation). 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 12 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.