Microcirculation in Spontaneous Breathing Trial

Association Between Change of Microcirculation After Spontaneous Breathing Trial and Ventilator Weaning

Weaning ventilator support in critically ill patients is crucial. Both delayed extubation and unexpected early reintubation are harmful to the patients. Weaning parameters and spontaneous breathing trial are used to investigate the indication and predict the successful extubation. Hemodynamic stability and physical reserve are important indicators as well. Microcirculation parameters are known to be more sensitive to the change of hemodynamic status than macrocirculation parameters. We hypothesize that the change of sublingual microcirculation before and after spontaneous breathing trial is different between the the patients with successful extubation and the patients with failed extubation. Thus, this study measures sublingual microcirculation in patients receiving spontaneous breathing trial and record the extubation status (successful or failed). The microcirculation parameters before and after spontaneous breathing trial are compared between the the patients with successful extubation and the patients with failed extubation.

Study Overview

• Status: Completed
• Conditions: Critically Ill
• Intervention / Treatment: Other: Microcirculation examination

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients who are ready for weaning ventilator support and receive spontaneous breathing trial.

Description

Inclusion Criteria:

• critically ill patients received ventilator longer than 12 hours
• ready for spontaneous breathing trial
• GCS coma score equal or higher than 8

Exclusion Criteria:

• aged less than 20 years
• patient with tracheostomy
• patient and patients' relatives are non-native speakers

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Successful extubation; The patients pass the spontaneous breathing trial and are successful extubated without reintubation within 72 hours. .	Other: Microcirculation examination; Sublingual microcirculation images were recorded using an incident dark-field video microscope
Failed extubation; The patients pass the spontaneous breathing trial and are successful extubated with reintubation within 72 hours. .	Other: Microcirculation examination; Sublingual microcirculation images were recorded using an incident dark-field video microscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial total vessel density	Total vessel density measured by Cytocam before and after spontaneous breathing trial	0 hour
Change of total vessel density	The difference between the total vessel density measure by Cytocam before and after spontaneous breathing trial	baseline and 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial perfused vessel density	Perfused vessel density measured by Cytocam before spontaneous breathing trial	0 hour
Change of perfused vessel density	The difference between the perfused vessel density measure by Cytocam before and after spontaneous breathing trial	baseline and 1 hour

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: microcirculation; weaning; ventilator
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 201909036RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The data that support the findings of this study will be available from the corresponding author upon reasonable request and approval of the research ethic committee.

Drug and device information, study documents

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