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Completed

NCT Number: NCT04711590

Microcirculation in Spontaneous Breathing Trial

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.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microcirculation examination

Other

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

Primary outcomes

  1. Initial total vessel density

    Time frame: 0 hour

    Total vessel density measured by Cytocam before and after spontaneous breathing trial

  2. Change of total vessel density

    Time frame: baseline and 1 hour

    The difference between the total vessel density measure by Cytocam before and after spontaneous breathing trial

Secondary outcomes

  1. Initial perfused vessel density

    Time frame: 0 hour

    Perfused vessel density measured by Cytocam before spontaneous breathing trial

  2. Change of perfused vessel density

    Time frame: baseline and 1 hour

    The difference between the perfused vessel density measure by Cytocam before and after spontaneous breathing trial

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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