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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01646359
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Elective Posterior Lumbar Spinal Fusion Device: 1.Esophageal doppler monitor Device: 2. philips Intelivue MP70 monitors Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

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 Name: 1.CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.
Device: 2. philips Intelivue MP70 monitors 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 Name: 2.intellivue MP70, philips medical Systems, Suresnes, France

Primary Outcome Measures :
  1. PPV(Pulse pressure variation) [ Time Frame: 15 minutes after induction of anaesthesia at the supine position ]
  2. FTc(corrected flow time) [ Time Frame: 15 minutes after induction of anaesthesia at the supine position ]

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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01646359

Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yonsei University Identifier: NCT01646359     History of Changes
Other Study ID Numbers: 1-2010-0046
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012