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

NCT04139031 | Completed

• 1 other identifier: 4-2019-0848
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypovolemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pulse pressure variation during low tidal volume ventilation

  Procedure (During low tidal volume ventilation before fluid resuscitation)

Study Arms (1)

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

Interventions

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).

Fluid loading group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing postoperative mechanical ventilation with low tidal volume

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: November 5, 2019
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)