Effect of Loss-of-Resistance Syringe Training on Endotracheal Tube Cuff Pressure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYusuf YILMAZ
About this trial
This study will examine whether training the anesthesia team in a loss-of-resistance syringe technique is associated with improved breathing-tube cuff pressure in adults having surgery at Kayseri City Hospital. The cuff is an inflatable seal around the breathing tube. Pressure that is too high or too low may cause problems.
Approximately 180 adults will be observed during a two-week period before staff training and a two-week period after training. The treating clinical team will independently choose how to inflate each cuff as part of routine care; researchers will not assign patients to a technique. A researcher independent of the treating team will measure cuff pressure and will learn which technique was used only after the measurement.
The main outcome is the percentage of patients whose first measured cuff pressure is within 20-30 cmH2O, compared between the periods before and after training. Pressures outside this range will be corrected for patient safety after the first measurement is recorded. Researchers will also record cuff leakage, the need for additional air, and sore throat after the breathing tube is removed, once the patient is awake and able to answer questions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Undergoing general anesthesia with endotracheal intubation in the operating rooms of Kayseri City Hospital.
Able to communicate and undergo postoperative pain assessment.
Only the first surgical procedure for each patient is included.
Disqualifiers
Neurological, psychiatric or cognitive impairment preventing communication.
Surgery that may independently affect postoperative sore throat, such as ear, nose and throat surgery or upper gastrointestinal surgery.
Three or more laryngoscopy attempts during intubation.
Nasotracheal intubation.
Trial population
Consecutive adult surgical patients undergoing general anesthesia with endotracheal intubation at Kayseri City Hospital during the two-week observation period before anesthesia staff training and the two-week observation period after training. Participants must meet the inclusion and exclusion criteria. Only the first surgical procedure for each patient will be included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
180 Participants
are grouped into 2 trial groupsGroup A: Pre-Training Cohort
Group B: Post-Training Cohort
Trial outcomes
Primary outcomes
1
Proportion of Patients With Initial Endotracheal Tube Cuff Pressure Within 20-30 cmH2O
Percentage of patients whose initial endotracheal tube cuff pressure, measured with a cuff manometer after intubation and initial cuff inflation and before any corrective adjustment, is between 20 and 30 cmH2O inclusive. The proportion will be compared between the pre-training and post-training cohorts. Measurements are performed by researchers independent of the clinical team, who learn the cuff inflation technique only after recording cuff pressure. This binary outcome is the basis of the sample-size calculation.
Time frame
Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.Secondary outcomes
1
Initial Endotracheal Tube Cuff Pressure
Initial cuff pressure measured with a cuff manometer in cmH2O before corrective adjustment, analyzed as a continuous variable and compared between the pre-training and post-training cohorts. The researcher learns the cuff inflation technique only after recording the measurement.
Time frame
Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.2
Proportion of Patients With Endotracheal Tube Cuff Leakage
Percentage of patients with cuff leakage, recorded as present or absent based on information from the treating anesthesia team during initial cuff inflation and assessment. The proportion will be compared between the pre-training and post-training cohorts.
Time frame
During initial cuff inflation and assessment after endotracheal intubation in the index surgical procedure.3
Proportion of Patients Requiring Additional Air for Cuff Inflation
Percentage of patients requiring additional air after initial cuff inflation, recorded as yes or no based on information from the treating anesthesia team. The proportion will be compared between the pre-training and post-training cohorts.
Time frame
Periprocedural4
Proportion of Patients With Postoperative Sore Throat
Percentage of patients reporting sore throat when questioned after extubation during postoperative recovery, once awake and able to answer questions. Sore throat is recorded as present or absent and compared between the pre-training and post-training cohorts.
Time frame
At the first postoperative assessment after extubation when the patient is awake and able to answer questions, during recovery from the index surgical procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yusuf YILMAZ
Lead sponsor
Kayseri City Hospital
Sponsor institution
Source ClinicalTrials.gov
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