Effect of Cardiorespiratory Changes on Carotid Flow Time During Lung Resection Surgery

September 1, 2026 updated by: Manuel Vicente Granell Gil, University of Valencia

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Manuel Granell Gil Prof.
  • Phone Number: +34 609232031
  • Email: margry@uv.es

Study Locations

  • Spain
      • Valencia, Spain
        • Recruiting
        • Hospital General Valencia
        • Contact:
          • Prof. Manuel Granell, Dr
          • Phone Number: +34 609232031
          • Email: margry@uv.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Surgical population

Description

Inclusion Criteria:

  • patients scheduled to undergo thoracosocpic lung resection surgery

Exclusion Criteria:

  • carotid stenosis or abnormal anatomy of carotid artery that prevents visualization, emphysema, arrythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Longitudinal study
Repeated measurements design

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
enrollment phase (up to 2 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)

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.
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

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.
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)

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)
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)

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
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)
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).
enrollment phase (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital General Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Registro:24/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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