NCT07808749

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jan 2025Mar 2027

Study Start

First participant enrolled

January 27, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

June 30, 2026

Last Update Submit

September 1, 2026

Conditions

Keywords

carotid, cerebral circulationhemodynamic instability

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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.

    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

    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

    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.

    enrollment phase (up to 2 years)

Study Arms (1)

Longitudinal study

Repeated measurements design

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Surgical population

You may qualify if:

  • patients scheduled to undergo thoracosocpic lung resection surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Valencia

Valencia, Spain

RECRUITING

Central Study Contacts

Manuel Granell Gil Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 30, 2026

First Posted

September 9, 2026

Study Start

January 27, 2025

Primary Completion (Estimated)

December 17, 2026

Study Completion (Estimated)

March 15, 2027

Last Updated

September 9, 2026

Record last verified: 2026-09

Locations