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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02918526
Other study ID # AOUCareggi
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 24, 2016
Last updated September 28, 2016
Start date October 2016
Est. completion date June 2017

Study information

Verified date September 2016
Source Azienda Ospedaliero-Universitaria Careggi
Contact Alessandro Di Filippo, MD
Phone 3397219337
Email adifilippo@unifi.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of the study will be to record the hemodynamic response measured by traditional methods (non-invasive blood pressure and ECG) and Pressure Recording Analytical Method in patients undergoing laryngeal mask placement compared with the hemodynamic response measured in patients undergoing laryngoscopy and tracheal intubation for performing surgery in gynecological area and assess the differences with the two methods.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
airway management
airway management with Laryngeal Mask or Oro Tracheal Intubation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria Careggi

References & Publications (11)

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Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac Index (L/min/m2) Cardiac Index (L/min/m2) measured with Pulse Recording Analytic Method for 5 minutes after induction of anesthesia Yes
Secondary Heart rate (bpm) for 5 minutes after induction of anesthesia Yes
Secondary Blood pressure (mmHg) for 5 minutes after induction of anesthesia Yes
Secondary Cardiac Output (CO) (L/min) for 5 minutes after induction of anesthesia Yes
Secondary Stroke Volume (SV) (ml/beat) for 5 minutes after induction of anesthesia Yes
Secondary Stroke Volume Index (SVI) (ml/beat /m2) for 5 minutes after induction of anesthesia Yes
Secondary Systemic Vascular Resistance (SVR) (dynes•s /cm5) for 5 minutes after induction of anesthesia Yes
Secondary Cardiac Cycle Efficiency (CCE) (a dimensional value) for 5 minutes after induction of anesthesia Yes
Secondary Cardiac Power Output (CPO) (W). for 5 minutes after induction of anesthesia Yes
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