Hemodynamic MonitoringNCT07808749
Effect of Cardiorespiratory Changes on Carotid Flow Time During Lung Resection Surgery
An observational study of Hemodynamic Monitoring, run by University of Valencia at 1 site in Spain.
Trial summary
Cardiorespiratory changes during lung resection surgery, even though generally well tolerated, may lead to hemodynamic compromise, reducing venous return to the heart and hence cardiac output. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemodynamic Monitoring
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jan 2025to 15 Mar 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgical population
Who may be able to join
- patients scheduled to undergo thoracosocpic lung resection surgery
Who cannot join
- carotid stenosis or abnormal anatomy of carotid artery that prevents visualization, emphysema, arrythmia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Valencia
Valencia
Prof. Manuel Granell, Dr, 609232031 ext. +34, margry@uv.es
About this study
Official title: Noninvasive Perioperative Hemodynamic Monitoring In Thoracic Surgery: A Prospective Observational Study
Cardiorespiratory changes during lung resection surgery, even though generally well tolerated, may lead to hemodynamic compromise, reducing venous return to the heart and hence cardiac output.
Carotid corrected flow time is widely regarded as non-invasive index of preload status, yet its dynamic relationship with cardiac output, especially in surgical population is not well-studied. Understanding how cardiorespiratory changes affect carotid flow time in anesthesized patients remains limited. This study investigates corrected carotid flow time response to anesthesia, lateral position, one-lung ventilation, open chest, capnothorax, lung recruitment and volume expansion, hypothesizing that cFT declines in association with CO reduction during lung resection.
Read more
The secondary interest of the study is to test whether carotid flow time and its recruitment-induced change can adequately predict fluid response during one-lung ventilation. In addition, the baseline preoperative carotid flow time and its position-induced change are studied as potential predictors of hemodynamic tolerance to lung recruitment and fluid response, respectively.
Finally, the purpose of this study is to see if cardiorespiratory changes and volume expansion affect cerebral blood volume during lung resection surgery.
Read the detailed description
In this study investigators look at intraoperative trajectory of secondary variables (hemodynamic and ventilatory) during cardiorespiratory changes and volume expansion to provide clinical context for primary variable response. A comparative analysis of all variables is performed in patients with different sex, ventilation protocol, operative side, tolerance to recruitment and fluid responsiveness.
- Conditions
- Hemodynamic Monitoring
- Keywords
- carotid, cerebral circulation, hemodynamic instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal study | Repeated measurements design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corrected carotid artery flow (ccFT) in association with cardiorespiratory changes and volume expansion during lung resection surgery
Doppler ultrasonography measurements are performed repeatedly at following timepoints: awake (seated), awake (supine), after intubation, after lateral decubitus position, after transition to one-lung ventilation, after pleura opening, after carbon dioxide insufflation, before lung recruitment, after first highest PEEP, after second highest PEEP, after optimal PEEP, before and after volume expansion.
Statistical analysis: within-patient change (Friedman, Wilcoxon signed rank), correlation
Measured: enrollment phase (up to 2 years)
Secondary outcomes (5)
Diagnostic accuracy of corrected carotid flow time (ccFT) and recruitment - induced change in carotid corrected flow time (delta ccFTRM) in discriminating fluid responders during one-lung ventilation
Corrected carotid flow time (ccFT) is measured by Doppler ultrasonography immediately before volume expansion (VE) and 5 min after it.
Recruitment - induced change in carotid corrected flow time (delta cFTRM) is calculated from measurments obtained by Doppler utrasonography immediately before recruitment maneuver (RM) and at highest PEEP.
delta ccFTRM = (ccFT before RM - ccFTafter RM) / ccFT before RM
Fluid response is defined as > 15% increase in cardiac output (CO) following volume expansion (VE). Volume expansion is a 200-250 ml bolus of crystalloid solution performed after the recruitment maneuver (RM) at the discretion of attending anesthesiologist. Measurements are obtained by pulse contour analysis after immediately before volume expansion (VE) and 5 min after it.
Stat- ROC curve
Outcome measure - prognostic ability (AUC)of corrected carotid flow time (ccFT) and recruitment - induced change in carotid corrected flow time (delta ccFTRM) in predicting CO increase.
Measured: enrollment phase (up to 2 years)
Diagnostic accuracy of baseline preoperative carotid flow time (ccFT) in discriminating between poor and good tolerance to recruitment maneuver and preoperative position-induced change in ccFT in discriminating fluid responders and non-responders.
Baseline preoperative carotid corrected flow time (ccFT) is a preoperative carotid Doppler measurement in seated position.
Position-induced change (delta ccFT-P) is calculated from measurments obtained by Doppler utrasonography in awake seated position and within approxiamtely 10-15 minutes in awake supine position.
delta ccFTP = (ccFT awake seated - ccFTawake supine ) / ccFT awake seated
Poor tolerance to lung recruitment is defined as TWA-MAP of 20% decrease from baseline or absolute value < 65 mmHg measured during recruitment period or 10 min after. Measurements are obtained by pulse contour analysis from immediately before recruitment maneuver to 5 min after it.
Fluid response is defined as > 15% increase in cardiac output (CO) following volume expansion (VE). Volume expansion(VE) is a 200-250 ml bolus of crystalloid solution performed after the recruitment maneuver (RM) at discretion of attending anesthesiologist.
Measured: enrollment phase (up to 2 years); statistical analysis (ROC); outcome measure - prognostic ability (AUC) of preoperative corrected carotid flow time (ccFT) and position - induced change in ccFT (delta ccFTRM) in predicting poor tolerance or CO increase
Change in cerebral blood volume index (CBVIl, CBVIr) in association with cardiorespiratory changes and volume expansion during lung resection surgery
Doppler ultrasonography measurements are performed repeatedly at following timepoints: awake (seated), awake (supine), after intubation, after lateral decubitus position, after transition to one-lung ventilation, after pleura opening, after carbon dioxide insufflation, before lung recruitment, after first highest PEEP, after second highest PEEP, after optimal PEEP, before and after volume expansion.
Statistical analysis: within-patient change (Friedman, Wilcoxon signed rank), correlation (with cardiac output)
Measured: enrollment phase (up to 2 years)
Change in secondary hemodynamic and ventilatory variables in response to cardiorespiratory changes and volume expansion during lung resection surgery
Hemodynamic variables (CO, SV, MAP, HR, dP/dt, Eadyn, PI, BIS, carotid diameter, resistivity index) are obtained from pulse contour analysis/ Doppler and respiratory variables (EtCO2, Ppeak, PEEP, TV, SpO2, FiO2, RR) are obtained from mechanical ventilator continuously during the same timepoints as primary variable.
Outcome measure: all variables will be taken and reported at the following timepoints: awake (seated), awake (supine), after intubation, after lateral decubitus position, after transition to one-lung ventilation, after pleura opening, after carbon dioxide insufflation, before lung recruitment, after first highest PEEP, after second highest PEEP, after optimal PEEP, before and after volume expansion.
Statistical analysis: within-patient change (Friedman, Wilcoxon signed rank), correlation
Measured: enrollment phase (up to 2 years)
Comparative between-group analysis of primary and secondary variables in patients of different sex, ventilation protocol, operative side, recruitment tolerance and fluid response.
Hemodynamic (CO, SV, MAP, HR, dP/dt, Eadyn, PI, BIS, carotid diameter, resistivity index) are obtained from pulse contour analysis/ Doppler and respiratory variables (EtCO2, Ppeak, PEEP, TV, SpO2, FiO2, RR) will be collected at following timepoints: awake (seated), awake (supine), after intubation, after lateral decubitus position, after transition to one-lung ventilation, after pleura opening, after carbon dioxide insufflation, before lung recruitment, after first highest PEEP, after second highest PEEP, after optimal PEEP, before and after volume expansion. Comparative between-group analysis of variables response will be performed. Groups are stratified by sex, ventilation protocol, operative side, recruitment tolerance and fluid response. Statistical analysis: between-patient change (Mann-Whitney).
Measured: enrollment phase (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start27 Jan 2025
- Primary completion17 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MonitoringStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Valencia
- Responsible party
- Principal investigator, Manuel Vicente Granell Gil, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808749
- Sponsor's protocol ID
- Registro:24/2023
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2026
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Perioperative Hemodynamic Monitoring In Thoracic Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07808749
- Acronym / sponsor ID
- Registro:24/2023
- Conditions
- Hemodynamic Monitoring
- Keywords
- carotid, cerebral circulation, hemodynamic instability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital General Valencia
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
Cardiorespiratory changes during lung resection surgery, even though generally well tolerated, may lead to hemodynamic compromise, reducing venous return to the heart and hence cardiac output.
Carotid corrected flow time is widely regarded as non-invasive index of preload status, yet its dynamic relationship with cardiac output, especially in surgical population is not well-studied. Understanding how cardiorespiratory changes affect carotid flow time in anesthesized patients remains limited. This study investigates corrected carotid flow time response to anesthesia, lateral position, one-lung ventilation, open chest, capnothorax, lung recruitment and volume expansion, hypothesizing that cFT declines in association with CO reduction during lung resection.
The secondary interest of the study is to test whether carotid flow time and its recruitment-induced change can adequately predict fluid response during one-lung ventilation. In addition, the baseline preoperative carotid flow time and its position-induced change are studied as potential predictors of hemodynamic tolerance to lung recruitment and fluid response, respectively.
Finally, the purpose of this study is to see if cardiorespiratory changes and volume expansion affect cerebral blood volume during lung resection surgery.
Detailed description
In this study investigators look at intraoperative trajectory of secondary variables (hemodynamic and ventilatory) during cardiorespiratory changes and volume expansion to provide clinical context for primary variable response. A comparative analysis of all variables is performed in patients with different sex, ventilation protocol, operative side, tolerance to recruitment and fluid responsiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal study | – | –Repeated measurements design |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgical population
Key inclusion criteria (1 listed)
- patients scheduled to undergo thoracosocpic lung resection surgery
Key exclusion criteria (1 listed)
- carotid stenosis or abnormal anatomy of carotid artery that prevents visualization, emphysema, arrythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in corrected carotid artery flow (ccFT) in association with cardiorespiratory changes and volume expansion during lung resection surgery
Time frame: enrollment phase (up to 2 years)
Doppler ultrasonography measurements are performed repeatedly at following timepoints: awake (seated), awake (supine), after intubation, after lateral decubitus position, after transition to one-lung ventilation, after pleura opening, after carbon dioxide insufflation, before lung recruitment, after first highest PEEP, after second highest PEEP, after optimal PEEP, before and after volume expansion. Statistical analysis: within-patient change (Friedman, Wilcoxon signed rank), correlation
5 secondary outcomes
Diagnostic accuracy of corrected carotid flow time (ccFT) and recruitment - induced change in carotid corrected flow time (delta ccFTRM) in discriminating fluid responders during one-lung ventilation
Time frame: enrollment phase (up to 2 years)
Diagnostic accuracy of baseline preoperative carotid flow time (ccFT) in discriminating between poor and good tolerance to recruitment maneuver and preoperative position-induced change in ccFT in discriminating fluid responders and non-responders.
Time frame: enrollment phase (up to 2 years); statistical analysis (ROC); outcome measure - prognostic ability (AUC) of preoperative corrected carotid flow time (ccFT) and position - induced change in ccFT (delta ccFTRM) in predicting poor tolerance or CO increase
Change in cerebral blood volume index (CBVIl, CBVIr) in association with cardiorespiratory changes and volume expansion during lung resection surgery
Time frame: enrollment phase (up to 2 years)
Change in secondary hemodynamic and ventilatory variables in response to cardiorespiratory changes and volume expansion during lung resection surgery
Time frame: enrollment phase (up to 2 years)
Comparative between-group analysis of primary and secondary variables in patients of different sex, ventilation protocol, operative side, recruitment tolerance and fluid response.
Time frame: enrollment phase (up to 2 years)
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 9 Sep 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.
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 Hemodynamic Monitoring, run by University of Valencia at 1 site in Spain.
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 1 inclusion and 1 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 9 Sep 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 Spain. 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 Manuel Granell Gil Prof. (609232031 ext. +34, margry@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corrected carotid artery flow (ccFT) in association with cardiorespiratory changes and volume expansion during lung resection surgery (time frame: enrollment phase (up to 2 years)). 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 9 Sep 2026.