Value of Pulse Pressure Variations and Corrected Flow Time in Esophageal Doppler as a Predictor of Fluid Responsiveness in Prone Position During Spinal Surgery

July 19, 2012 updated by: Yonsei University
In patients under mechanical ventilation, Usefulness of dynamic indices based on the heart-lung interactions for guiding volume resuscitation has been well validated. Recently, validity of pulse pressure variation (PPV) has been also reported to predict fluid responsiveness. Oesophageal Doppler (OED) allows continuous monitoring of several important hemodynamic variables. Of the OED variables, corrected flow time (FTc) has been evaluated and used as a preload index, and has been reported to predict fluid responsiveness. Prone position caused physiologic and hemodynamic changes and influenced the predictability and cut-off values of SVV and PPV for fluid responsiveness. In this prospective controlled study, the investigators evaluated the validity of PPV and FTc as predictors for fluid responsiveness in supine and prone position in patients undergoing posterior lumbar spinal fusion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine and Anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing elective spine surgery
  • age : > 20 and < 70, 3. Patients expecting intraoperative blood loss more than 10% of estimated blood volume

Exclusion Criteria:

  • arrhythmias
  • BMI > 30 kg/m2
  • valvular heart disease
  • left ventricular ejection fraction < 50%
  • history of lung disease
  • pregnancy
  • foreigner
  • contraindications to esophageal doppler monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, intra-aortic balloon pump, coarctation of the aorta, and severe coagulopathy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: corrected flow time
Device: 1.Esophageal doppler monitor
1.Esophageal doppler monitor (CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.)-inserted into the esophagus and positioned approximately 35-40 cm from the teeth. The position of OED prove was confirmed by continuously measuring blood flow velocity in the descending thoracic aorta and focused to find the optimum peak velocity and waveform signal.
Other Names:
  • 1.CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.
Device: 2. philips Intelivue MP70 monitors
2.philips Intelivue MP70 monitors (Intellivue MP70, philips medical Systems, Suresnes, France) -a radial arterial cannula was inserted and arterial pressure waveforms were monitored through Philips Intelivue MP70 monitors. In the monitor, PPVauto was displayed in real-time. It based on automatic detection algorithms, kernel smoothing, and rank-order filters.
Other Names:
  • 2.intellivue MP70, philips medical Systems, Suresnes, France

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PPV(Pulse pressure variation)
Time Frame: 15 minutes after induction of anaesthesia at the supine position
15 minutes after induction of anaesthesia at the supine position
FTc(corrected flow time)
Time Frame: 15 minutes after induction of anaesthesia at the supine position
15 minutes after induction of anaesthesia at the supine position

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

July 15, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (ESTIMATE)

July 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 1-2010-0046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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