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

Completed

• Conditions: Hypovolemic
• Interventions: Device: Ultrasonographic measurement of corrected flow time in carotid artery

• Registration Number: NCT04139031
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Study Start: 2019-11-05
• Primary Completion: 2020-09-25
• Study Completion: 2020-09-25
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fluid loading group	Ultrasonographic measurement of corrected flow time in carotid artery	Mechanically ventilated patients with low tidal volume in the intensive care unit whom clinician decided to provide fluid for correction of hypovolemia

Primary Outcome Measures

Name	Time	Method
Corrected carotid artery flow time during low tidal volume ventilation	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 Outcome Measures

Name	Time	Method
Pulse pressure variation during low tidal volume ventilation	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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of