Effect of endotracheal cuff pressure monitoring and regulation by conventional method using a manometer compared to using a smart cuff manager in intubated Intensive Care Unit patients and nursing outcomes of such practices

Not Applicable

Recruiting

• Conditions: ursing staff managing ventilated patients in ICU; Nursing staff managing ventilated patients in ICU; Public Health - Health service research

• Registration Number: ACTRN12616000891426
• Lead Sponsor: niversity Malaya Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

All staff nurses working in the ICU and fulfill the inclusion criteria for nurses:
(i)had more than six months working experience in critical care units and
(ii)willingness to participate.

Patients who will be included are:
All adult ICU patients above 18 years old who are intubated with an orotracheal tube or tracheostomy tube.

Exclusion Criteria

Nurses with less than 6 months of experience in ICU
Unwillingness to participate

Patient's 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
ursing knowledge regarding cuff pressure management techniques based on pre and post teaching questionnaire which was specifically designed for this study[Assessed prior to teaching sessions and after the conclusion of the study];To compare the efficacy of the Tracoe Smart Cuff Manager as compared to the conventional way of ETT cuff pressure management - ETT cuff pressure will be monitored every 4-6 hourly for each patient. It will be assessed by the number of readings on the manometer which is outside the recommended range (20-30cmH20)<br> [ETT cuff pressure will be measured every 4-6hours for all patients throughout the period of intubation or until day 15 of intubation, whichever is longer]

Secondary Outcome Measures

Name	Time	Method
To compare between the 2 groups of patients - developement of post extubation stridor, sore throat and requirement for reintubation (a composite secondary outcome). This will be assessed by observation of the patient post extubation. Patients will also be asked if they are experiencing sore throat.<br> [Patients will be assessed for these signs and symptoms post extubation which indicates tracheal mucosal injury]