SV With TTPEE Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients

ConditionTracheostomy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCapital Medical University

About this trial

The aim of this study is to evaluate the feasibility of predicting upper airway patency in patients with prolonged tracheostomy using a non-invasive method combining speaking valve (SV) and transtracheal end-expiratory pressure (TTPEE) through a multicenter study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Weaned from ventilator more than 48 hours

No any organ failure

No sepsis

Stable heart rate and blood pressure

Disqualifiers

Serious dysfunction of vital organs

Inability to tolerate cuff deflation

Laryngopharyngeal trauma

Known severe upper airway obstruction before referrer to our department

Trial design

Design model

Crossover

Treatments tested in this trial

Speaking valve combined with airway pressure
Diagnostic test
All patients wore speaking valves for 30 minutes, during which the transtracheal end-expiratory pressure was measured to assess the patency of the upper airway.
Bronchoscopy
Diagnostic test
The same examiner performed bronchoscopy on all patients to assess upper airway patency.

Treatment groups

300 Participants

are divided into 4 treatment groups

Group A: True positive groupExperimental treatment 2 interventions

Group B: False positive groupExperimental treatment 2 interventions

Group C: True negative groupExperimental treatment 2 interventions

Group D: False negative groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency

Patients enrolled in the study will undergo both SV with transtracheal end-expiratory pressure measurement and bronchoscopy. Upper airway non-patency will be defined as positive. Using the results of bronchoscopy as the gold standard, the sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement will be evaluated.

Time frame

The patients started using the SV with the TTPEE measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

Source ClinicalTrials.gov

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