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

Hypovolemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139031
• Other study ID #: 4-2019-0848
• Status: Completed
• Start date: November 5, 2019
• Est. completion date: September 25, 2020

Study information

• Verified date: October 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients with age more than 19

2. Undergoing postoperative mechanical ventilation with low tidal volume

3. Clinically diagnosed with hypovolemic status

4. 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:

1. Body mass index <40 or >15 kg/m2

2. Medical history of carotid artery stenosis >50% or diagnosed while examination

3. Cardiac arrhythmia other than normal sinus rhythm

4. Moderate or severe valvular heart disease, intracardiac shunt, heart failure, pulmonary hypertension

5. Moderate or severe chronic obstructive pulmonary disease

6. Increased intracranial pressure

7. Using vasopressor

8. Pregnancy

Related Conditions & MeSH terms

• Hypovolemia
• Hypovolemic

Intervention

Device:
• Ultrasonographic measurement of corrected flow time in carotid artery
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/vcycle time).

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected carotid artery flow time during low tidal volume ventilation	Area under the receiver operating curve of Corrected carotid artery flow time for fluid responsiveness in low tidal volume ventilator setting before fluid resuscitation	Procedure (During low tidal volume ventilation before fluid resuscitation)
Secondary	Pulse pressure variation during low tidal volume ventilation	Area under the receiver operating curve of pulse pressure variation for fluid responsiveness in low tidal volume ventilator setting before fluid resuscitation	Procedure (During low tidal volume ventilation before fluid resuscitation)