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.

Study Overview

• Status: Completed
• Conditions: Hypovolemic
• Intervention / Treatment: Device: Ultrasonographic measurement of corrected flow time in carotid artery

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing postoperative mechanical ventilation with low tidal volume

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Fluid loading group; Mechanically ventilated patients with low tidal volume in the intensive care unit whom clinician decided to provide fluid for correction of hypovolemia

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/√cycle time).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2019
• Primary Completion (ACTUAL): September 25, 2020
• Study Completion (ACTUAL): September 25, 2020

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (ACTUAL): October 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: 4-2019-0848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No