Endotracheal Tube (ETT) Cuff Pressure Monitoring And Regulation – a comparison between conventional, intermittent monitoring method using a handheld manometer and continuous ETT cuff presure monitoring method using the Tracoe Smart Cuff Manager in an adult Intensive Care Unit setting.

Not Applicable

Recruiting

• Conditions: Patients requiring mechanical ventilation; Prevention of microaspiration; Anaesthesiology - Other anaesthesiology; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12616000817448
• Lead Sponsor: niversity Malaya Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

All adult ICU patients above 18 years old who are intubated with an orotracheal tube or tracheostomy tube.

Exclusion Criteria

Patients with upper airway pathology
Patients with underlying chronic lung disease or restrictive lung disease
Patients who may have aspirated during intubation (e.g difficult intubation, food particles in oral cavity during intubation)
Patient who are ventilated in the general ward or who have been ventilated in the general ward for more than 24 hours prior to ICU admission.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maintainence of the ETT cuff pressures between 20-30cmH20 using the conventional method or using the Tracoe Smart Cuff Manager. Proportion of time during which the ETT cuff pressure is within the normal limit will be assessed by a handheld manometer measurement taken 6 hourly for all patients. [Throughout the patient's intubation period or up to day 15 of intubation, whichever is longer];To assess the risk of tracheal mucosal injury in patients with continuous cuff pressure control system versus patients on intermittent cuff pressure monitoring by assessing patient's post extubation - patient will be assessed for hoarseness of voice (judged by medical staff), sore throat and post extubation stridor which could indicate tracheal mucosal injury[After extubation of patient]

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of the continuous cuff pressure control system - via observation of the patient and from nursing records[Throughout patient's intubation period or up to day 15 of intubation, whichever is longer];To compare rates of VAP between the continuous cuff pressure control system and the intermittent cuff pressure monitoring method - patient's will be evaluated daily for VAP - VAP will be diagnosed based on increase in ventilator settings with:<br>- hypothermia or hyperthermia or WBC > 12000 or < 4000 cells/mm3<br>- a new antimicrobial agent is started and continued for more than 4 days<br>- purulent respiratory secretions or positive culture from respiratory secretions[Up to 48 hours post extubation]