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NCT Number: NCT07808749

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

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.

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Key information

Conditions

Hemodynamic Monitoring

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Valencia

Valencia, Spain

Location status: Recruiting

Location contact

Prof. Manuel Granell, Dr

CONTACT

[email protected]

609232031 ext. +34

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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

  5. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Granell Gil Prof.

CONTACT

[email protected]

609232031 ext. +34

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Hospital General Valencia

Registry information

Official study title

Noninvasive Perioperative Hemodynamic Monitoring In Thoracic Surgery: A Prospective Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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