Corrected Flow Time in the Carotid Artery as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume in the Intensive Care Unit

The purpose of this study is to evaluate predictability of carotid corrected flow time for fluid responsiveness in mechanically ventilated patients with low tidal volume in the intensive care unit.

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Key information

Conditions

Hypovolemic Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult patients with age more than 19
Undergoing postoperative mechanical ventilation with low tidal volume
Clinically diagnosed with hypovolemic status
If one of follow criteria is satisfied 1) Systolic blood pressure <90mmHg 2) Mean arterial pressure(MBP)<70mmHg or fall more than 20% from baseline 3) Heart rate >100bpm 4) Urine output <0.5mg/kg/hr more than 1 hour 5) Arterial lactate >2mmol/L 6) Capillary refilling time >3secs

Exclusion criteria

Body mass index <40 or >15 kg/m2
Medical history of carotid artery stenosis >50% or diagnosed while examination
Cardiac arrhythmia other than normal sinus rhythm
Moderate or severe valvular heart disease, intracardiac shunt, heart failure, pulmonary hypertension
Moderate or severe chronic obstructive pulmonary disease
Increased intracranial pressure
Using vasopressor
Pregnancy

Treatment and study plan

ultrasonographic measurement of corrected flow time in carotid artery

Device

Corrected carotid artery flow time is measured using 6-13 MHz linear probe on a portable ultrasound machine. On the two-dimensional image, the optimal image of the long-axis view is obtained at the left common carotid artery. The sample volume is placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination was performed while the Doppler beams were adjusted to ensure < 60° of angle for the best signal. Then, cardiac cycle time and carotid flow time is measured. Carotid flow time is measured between the upstroke of the flow tracing and the dicrotic notch, and it is corrected for pulse rate by dividing flow time by the square root of the cardiac cycle time to calculate corrected carotid artery flow time (flow time/√cycle time).

Primary outcomes

Corrected carotid artery flow time during low tidal volume ventilation

Time frame: Procedure (During low tidal volume ventilation before fluid resuscitation)

Area under the receiver operating curve of Corrected carotid artery flow time for fluid responsiveness in low tidal volume ventilator setting before fluid resuscitation

Secondary outcomes

Pulse pressure variation during low tidal volume ventilation

Time frame: Procedure (During low tidal volume ventilation before fluid resuscitation)

Area under the receiver operating curve of pulse pressure variation for fluid responsiveness in low tidal volume ventilator setting before fluid resuscitation

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Oct 25, 2019
Registry last updated: Oct 19, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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