Microcirculation in Spontaneous Breathing Trial

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711590
• Other study ID #: 201909036RINB
• Status: Completed
• Start date: December 5, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 30, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Other:
• Microcirculation examination
Sublingual microcirculation images were recorded using an incident dark-field video microscope

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial total vessel density	Total vessel density measured by Cytocam before and after spontaneous breathing trial	0 hour
Primary	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	Initial perfused vessel density	Perfused vessel density measured by Cytocam before spontaneous breathing trial	0 hour
Secondary	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