Respiratory Aspiration of Gastric Contents
Conditions
Interventions
This is a prospective, experimental, non-controlled, single-arm, open-label study designed to validate a manual technique for inflating the endotracheal tube cuff without the use of a manometer in pat
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years or older; both sexes; classified as ASA I, II, or III, according to the American Society of Anesthesiologists; who will undergo general anesthesia with the need for orotracheal intubation; signature of the Informed Consent Form by the patient or by his/her legal representative
Exclusion criteria
Exclusion criteria: Patients with a history of previous tracheal disease; emergency or major surgeries involving the airway; known tracheal lesions; or the presence of anatomical abnormalities that make orotracheal intubation difficult
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To validate the efficacy of the proposed manual technique for tracheal tube cuff inflation. It is expected that the technique will achieve the ideal pressure range (20 to 30 cmH2O) more consistently than the currently used manual method, which reaches the ideal pressure in only about 50% of cases. The outcome will be verified through serial cuff pressure measurements with a calibrated manometer, after controlled deflation and progressive reinflation in 0.5 ml increments. The mean volume of air required to reach the ideal pressure range and the proportion of patients in whom the target is achieved will be analyzed | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the reproducibility of the manual cuff inflation technique, verified by repeating the procedure in different patients and recording the required volume in each case. The outcome will be measured by intra- and interpatient variability, analyzed statistically using dispersion measures (standard deviation, interquartile range, and correlation coefficients). Low variability among patients is expected, suggesting consistency of the method;To assess the practical applicability of the technique in the surgical setting, considering execution time, ease of learning, and cost-effectiveness. The outcome will be verified by recording the duration of the procedure (in seconds), by the anesthesiologist’s reported perception of complexity, and by descriptive analysis of costs. The technique is expected to be quick, easy to learn, and low-cost | — |
Countries
Brazil
Contacts
Public ContactFelipe de Albuquerque
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed