None listed
Conditions
Brief summary
We aim to investigate the applicability of one common methods of ETTc inflation such as finger estimation compared to three other less commonly applied methods in clinical practice such as minimal occlusive volume, minimum leak technique and a method with limited application involving air return back into the syringe after cuff overinflation. Thus we will study the comparable changes in ETTc pressure, the air needed for the final ETT cuff inflation and the possible complications associated with each method We would like to test the hypothesis that the less commonly applied methods for ETTc inflation are superior compared to the finger palpation technique and among these three methods to ascertain which is the optimal ETTc sealing practice.
Interventions
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 auscultat
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.
Sponsors
Georgia Tsaousi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed