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CompletedNCT06962748Updated Mar 12, 2026

End-tidal Carbon Dioxide as a Non-invasive Predictor for Changes in Cardiac Output in Non-cardiac Surgery

An interventional study of cerebral blood flow measurment and TTE CO measurment in Non Cardiac Surgery, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Ain Shams University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Non Cardiac Surgery

Keywords

  • ETCO2- Cardiac output-Carotid blood flow
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • Active comparator
    ETCO2

    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

    Diagnostic Test: ETCO2

  • Active comparator
    TTE CO

    a transthoracic echocardiography will be done to measure the cardiac output

    Diagnostic Test: TTE CO measurment

  • Active comparator
    carotid blood flow

    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

    Diagnostic Test: cerebral blood flow measurment

Interventions

  • Diagnostic testcerebral blood flow measurment

    measuring CO using cerebral blood flow

  • Diagnostic testTTE CO measurment

    measuring CO using TTE

  • Diagnostic testETCO2

    measure the average ETCO2 over 30 minutes period

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: during operation

07

Study locations

1 site
  • Ain Shams University
    Cairo, Abbasiya 12245, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06962748
Lead sponsor
Ain Shams University
Responsible party
Adham Haggag (Dr, Ain Shams University) — Principal investigator
First posted
May 8, 2025
Start date
Jun 1, 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025
Last update
Mar 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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