Differences in endotracheal tube cuff sealing by applying four methods of endotracheal tube cuff inflation in patients undergoing general surgery procedures

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000699561
• Date of registration: 03/07/2015
• Prospective Registration: No
• Primary sponsor: Georgia Tsaousi
• Public title: Differences in endotracheal tube cuff sealing by applying four methods of endotracheal tube cuff inflation in patients undergoing general surgery procedures
• Scientific title: Assessment of four methods of endotracheal tube cuff inflation in terms of optimal cuff sealing in surgical population
• Date of first enrolment: 04/05/2015
• Target sample size: 150
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000699561.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Greece

Contacts

• Name: A/Prof Georgia Tsaousi

• Name: A/Prof Georgia Tsaousi

Key inclusion & exclusion criteria

Inclusion criteria: Adult patients, ASA physical status 1 to 3, Mallampati score 1-2, oral endotracheal intubation with a high-volume and low-pressure endotracheal tube, N2O free general anesthesia, intraoperative normothermia, conventional mechanical ventilation.
Exclusion criteria: Tracheostomy, surgical procedures involving the neck or the upper airwa, laryngo-tracheal pathology, history of previous tracheostomy, high-frequency oscillatory ventilation, history of difficult airway management, above 2 intubation attempts and prone positioning.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

endotracheal tube cuff sealing;complications from endotracheal cuff tube overinflation;
endotracheal tube cuff sealing
complications from endotracheal cuff tube overinflation

Anaesthesiology - Anaesthetics

Injuries and Accidents - Other injuries and accidents

Respiratory - Other respiratory disorders / diseases

Intervention(s)

After endotracheal intubation, we would apply four different methods for ETT cuff (ETTc) inflation in four different subgroups of patients (as they occur from randomization):
1) inflation of ETTc as usual practice and assessment of adequacy of inflation with finger estimation [Palpation],
2) ETTc will be overinflated and then it will be checked for air return back into the syringe [Air-return],
3) inflation of ETTc up to the point that no sound of air leakage will be heard by direct auscultation [minimal occlusive volume assessed by direct auscultation of air leak (MinVol)] and
4) inflation of ETTc up to the point that no sound of air leakage will be heard over trachea using stethoscope [minimum air leak assessed with stethoscope (MinLeak)].
The ETTc pressure will be measured with a non-invasive manometer via the pilot balloon.
The duration of each method is estimated to be less than 1 minutes for the first and second method and about 2 mnutes for the third and fourth method.

Primary Outcome(s)

The air needed for ETT cuff inflation in each method. This will be measured as ml of air used to inflate the cuff with a pre-filled with air 10 ml-syringe.[As soon as ETT cuff inflation is completed]

The ETT cuff pressure obtained by each method of cuff inflation.
This will be based on the indications obtained by a non-invasive manometer applied in the pilot balloon.[Just after ETT cuff inflation]

Secondary Outcome(s)

Presence of complications such as hoarseness (dysphonia) that might occur in each method of ETT cuff inflation. The patient will be assessed with the GRBAS scale. This is a subjective rating scale providing a measure of the overall grade (G), roughness (R), breathiness (B), asthenia or weakness (A), and strain (S) of dysphonia as judged by the listener on a scale of 0 to 4 (0: normal, 1: mild, 2: moderate, 3: moderate to severe, 4: severe).[Two, six and twenty-four hours postoperatively ]

Presence of complications such as sore throat, that might occur in each method of ETT cuff inflation. This will be based on patient's self-reporting of painful sensation localized to the pharynx or surrounding anatomy.[Two, six and twenty-four hours postoperatively ]

Presence of complications such as dysphagia that might occur in each method of ETT cuff inflation. This will be assessed by Functional Oral Intake Scale numbered as 1 the worse and as 7 the best response.[Two, six and twenty-four hours postoperatively ]

Secondary ID(s)

None

Ethics review

Status: Approved
Approval date:
Contact:

Scientific Board of AHEPA University Hospital

Results

• Results available: Yes
• Date Posted: 26/11/2019
• Date Completed: 19/04/2016