Effect of Loss-of-Resistance Syringe Training on Endotracheal Tube Cuff Pressure

NCT07844486 | Not Yet Recruiting

• 2 other identifiers: KCH-LOR-20261078
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endotracheal Tube Cuff Pressure; Postoperative Sore Throat

Keywords

Loss-of-resistance syringe; Anesthesia education

Outcome Measures

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.

  Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.

Secondary Outcomes (4)

• Initial Endotracheal Tube Cuff Pressure

  Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.

• Proportion of Patients With Endotracheal Tube Cuff Leakage

  During initial cuff inflation and assessment after endotracheal intubation in the index surgical procedure.

• Proportion of Patients Requiring Additional Air for Cuff Inflation

  Periprocedural

• Proportion of Patients With Postoperative Sore Throat

  At the first postoperative assessment after extubation when the patient is awake and able to answer questions, during recovery from the index surgical procedure.

Study Arms (2)

Pre-Training Cohort

Consecutive eligible adults undergoing general anesthesia with endotracheal intubation during the two-week period before staff training. Cuff inflation is selected and performed independently by the treating clinical team as part of routine care. An independent researcher records initial cuff pressure before corrective adjustment and learns the inflation technique only afterward. Cuff leakage, additional air requirement and postoperative sore throat are assessed.

Post-Training Cohort

Consecutive eligible adults undergoing general anesthesia with endotracheal intubation during the two-week period after staff training in the loss-of-resistance syringe technique. The treating clinical team independently chooses and performs the cuff inflation technique in routine care; no technique is assigned by researchers. An independent researcher records initial cuff pressure before corrective adjustment and learns the technique only afterward. Cuff leakage, additional air requirement and postoperative sore throat are assessed using the same procedures as in the pre-training cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Use of a double-lumen endotracheal tube.
• Intubation lasting longer than three hours.

Sponsors & Collaborators

• Yusuf YILMAZ: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

Location

Related Publications (1)

• Bulamba F, Kintu A, Ayupo N, Kojjo C, Ssemogerere L, Wabule A, Kwizera A. Achieving the Recommended Endotracheal Tube Cuff Pressure: A Randomized Control Study Comparing Loss of Resistance Syringe to Pilot Balloon Palpation. Anesthesiol Res Pract. 2017;2017:2032748. doi: 10.1155/2017/2032748. Epub 2017 Dec 31.

  PMID: 29463980 BACKGROUND

Study Officials

• Yusuf Yilmaz, MD

  Kayseri City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yusuf Yilmaz, MD

CONTACT

+90 555 538 30 94; doktoryusufyilmaz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator; Specialist in Anesthesiology and Reanimation

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)