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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01646359
First received: July 15, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Elective Posterior Lumbar Spinal Fusion
 Device: 1.Esophageal doppler monitor
Device: 2. philips Intelivue MP70 monitors

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • PPV(Pulse pressure variation) [ Time Frame: 15 minutes after induction of anaesthesia at the supine position ] [ Designated as safety issue: No ]
  • FTc(corrected flow time) [ Time Frame: 15 minutes after induction of anaesthesia at the supine position ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 Name: 2.intellivue MP70, philips medical Systems, Suresnes, France

  Eligibility

Ages Eligible for Study:   21 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646359

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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01646359     History of Changes
Other Study ID Numbers: 1-2010-0046
Study First Received: July 15, 2012
Last Updated: July 19, 2012
Health Authority: South Korea: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013