Microcirculation in Spontaneous Breathing Trial

NCT04711590 | Completed

• 1 other identifier: 201909036RINB
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill

Keywords

ventilator; weaning; microcirculation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Initial perfused vessel density

  0 hour

• Change of perfused vessel density

  baseline and 1 hour

Study Arms (2)

Successful extubation

The patients pass the spontaneous breathing trial and are successful extubated without reintubation within 72 hours. .

Other: Microcirculation examination

Failed extubation

The patients pass the spontaneous breathing trial and are successful extubated with reintubation within 72 hours. .

Other: Microcirculation examination

Interventions

Microcirculation examination OTHER

Sublingual microcirculation images were recorded using an incident dark-field video microscope

Failed extubation; Successful extubation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: December 5, 2019
• Primary Completion: June 13, 2022
• Study Completion: September 30, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-04

Locations

TW (1)