Completed

NCT Number: NCT01646359

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

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

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Key information

Conditions

Elective Posterior Lumbar Spinal Fusion

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine and Anesthesia

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

1.Esophageal doppler monitor

Device

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.

2. philips Intelivue MP70 monitors

Device

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

Primary outcomes

PPV(Pulse pressure variation)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jul 20, 2012
Registry last updated: Jul 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.