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Clinical Trials/NCT02918526
NCT02918526UnknownNot Applicable

Hemodynamic Study With Pressure Recording Analytical Method (PRAM) of the Cardiovascular Response to the Positioning of the Extraglottic Device in Gynecological Surgery

Azienda Ospedaliero-Universitaria Careggi0 sites94 target enrollmentStarted: October 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
94
Primary Endpoint
Cardiac Index (L/min/m2)

Study Overview

Brief 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.

Detailed Description

Introduction Laryngoscopy and tracheal intubation may cause significant hemodynamic changes in the patient and induce cardiovascular complications.

Numerous studies have sought methods to reduce this risk (1-5). The extraglottic not involving either laryngoscopy or their passage through the vocal cords, have proven protective of the possible cardiovascular complications resulting from the placement of respiratory prosthesis (6,7).

Measurements of hemodynamic changes resulting from the procedures for airway management with extraglottic have not previously been carried out.

The MostCare (Vytech, Vygon Italia srl, Padova, Italy) is a monitor provided for more than 10 years at the obstetric gynecological anesthesia unit able to evaluate the hemodynamic changes in a patient based on the Pressure Recording Analytical Method (PRAM).

This is a measurement method of the cardio-circulatory performance of a patient that does not require calibration and / or insertion of a pre-estimated data because the method of analysis of the wave form of the arterial pressure is developed completely a priori (8). The measurement derives from the simultaneous analysis of the components of a pulsatile flow and the continuous flow as a ratio between the area under the curve of the pulsatile portion of the systolic pressure and the characteristic impedance Z (t). The PRAM method has proven effective in many clinical settings (9).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cardiac Index (L/min/m2)

Time Frame: for 5 minutes after induction of anesthesia

Cardiac Index (L/min/m2) measured with Pulse Recording Analytic Method

Secondary Outcomes

  • Blood pressure (mmHg)(for 5 minutes after induction of anesthesia)
  • Stroke Volume Index (SVI) (ml/beat /m2)(for 5 minutes after induction of anesthesia)
  • Heart rate (bpm)(for 5 minutes after induction of anesthesia)
  • Cardiac Cycle Efficiency (CCE) (a dimensional value)(for 5 minutes after induction of anesthesia)
  • Stroke Volume (SV) (ml/beat)(for 5 minutes after induction of anesthesia)
  • Cardiac Output (CO) (L/min)(for 5 minutes after induction of anesthesia)
  • Systemic Vascular Resistance (SVR) (dynes•s /cm5)(for 5 minutes after induction of anesthesia)
  • Cardiac Power Output (CPO) (W).(for 5 minutes after induction of anesthesia)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alessandro Di Filippo

Medical Doctor

Azienda Ospedaliero-Universitaria Careggi

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