Effect of Cardiorespiratory Changes on Carotid Flow Time During Lung Resection Surgery
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Manuel Granell Gil Prof.
- Numéro de téléphone: +34 609232031
- E-mail: margry@uv.es
Lieux d'étude
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Valencia, Espagne
- Recrutement
- Hospital General Valencia
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Contact:
- Prof. Manuel Granell, Dr
- Numéro de téléphone: +34 609232031
- E-mail: margry@uv.es
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Longitudinal study
Repeated measurements design
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change in corrected carotid artery flow (ccFT) in association with cardiorespiratory changes and volume expansion during lung resection surgery
Délai: enrollment phase (up to 2 years)
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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)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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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
Délai: enrollment phase (up to 2 years)
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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)
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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.
Délai: 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
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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
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Change in cerebral blood volume index (CBVIl, CBVIr) in association with cardiorespiratory changes and volume expansion during lung resection surgery
Délai: enrollment phase (up to 2 years)
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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)
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Change in secondary hemodynamic and ventilatory variables in response to cardiorespiratory changes and volume expansion during lung resection surgery
Délai: enrollment phase (up to 2 years)
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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)
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Comparative between-group analysis of primary and secondary variables in patients of different sex, ventilation protocol, operative side, recruitment tolerance and fluid response.
Délai: enrollment phase (up to 2 years)
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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).
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enrollment phase (up to 2 years)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Registro:24/2023
Informations sur les médicaments et les dispositifs, documents d'étude
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