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

Capital Medical University300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

300

Conditions

Tracheostomy

Interventions

Speaking valve combined with airway pressureDIAGNOSTIC_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.

BronchoscopyDIAGNOSTIC_TEST

The same examiner performed bronchoscopy on all patients to assess upper airway patency.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Weaned from ventilator more than 48 hours * No any organ failure * No sepsis * Stable heart rate and blood pressure * Lung infection under control * PCO2\<60mmHg * Patient and family sign informed consent form Exclusion Criteria: * Serious dysfunction of vital organs * Inability to tolerate cuff deflation * Laryngopharyngeal trauma * Known severe upper airway obstruction before referrer to our department * Endoscopy(bronchoscopy or laryngoscopy) has been performed and the condition of the upper airway has known

Locations (5)

Hunan Rehabilitation Hospital

Hunan, Hunan, China

RECRUITING

Jiangbin Hospital of Guangxi Zhuang Autonomous Region

Guangxi, Jiangbin, China

RECRUITING

Beijing Rehabilitation Hospital of Capital Medical University

Beijing, Shijingshan, China

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.

Central Contacts

Hongying Jiang, MD

CONTACT

+8656981555 6jhy@163.com

Data from ClinicalTrials.gov

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