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临床试验/NCT07844486
NCT07844486尚未招募不适用

Effect of Training in the Loss-of-Resistance Syringe Technique on Optimizing Endotracheal Tube Cuff Pressure: A Prospective Before-and-After Study

Yusuf YILMAZ1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
Proportion of Patients With Initial Endotracheal Tube Cuff Pressure Within 20-30 cmH2O

研究概览

简要总结

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.

详细描述

This is a prospective, single-center observational before-and-after study in the operating rooms of Kayseri City Hospital. Consecutive eligible adult patients undergoing general anesthesia with endotracheal intubation will be observed in two temporal cohorts: a two-week pre-training cohort and a two-week post-training cohort. Only the first surgical procedure for each patient will be included.

Between the observation periods, anesthesia physicians and anesthesia technicians will receive standardized theoretical and practical education on cuff pressure management and the loss-of-resistance syringe technique. The education covers the target pressure range, the consequences of excessive or insufficient pressure, the syringe's low-friction plunger mechanism, and practical application. With this technique, the cuff is inflated through the pilot balloon valve using a loss-of-resistance syringe. Force on the plunger is then released, allowing it to move backward passively as air returns from the cuff. The syringe is disconnected when spontaneous plunger movement stops.

The clinical team independently decides whether and how to use a cuff inflation technique in routine clinical care. The research protocol does not assign patients to a technique. Researchers independent of the clinical team measure cuff pressure with a manometer after initial cuff inflation and before any corrective adjustment. The researcher measuring cuff pressure is unaware of the inflation technique until after the pressure has been measured and recorded. The initial value, rather than the value after safety correction, is used for the primary outcome. Pressures outside 20-30 cmH2O are corrected promptly for patient safety.

Cuff leakage and the need for additional air are recorded. Postoperative sore throat is assessed after extubation during postoperative recovery, once the patient is awake and able to answer questions. Demographic characteristics, surgical procedure, intubation attempts, tube characteristics and procedure durations are also recorded.

The primary analysis compares the proportion of patients with initial cuff pressure within 20-30 cmH2O between the pre-training and post-training cohorts, using the chi-square test or Fisher's exact test when appropriate. Cohorts are defined by observation period, not by the cuff inflation technique actually used. Continuous cuff pressure values will be compared using an independent-samples t test or the Mann-Whitney U test according to distribution. Secondary categorical outcomes will be compared using the chi-square test or Fisher's exact test. If appropriate, multivariable logistic regression will explore factors associated with postoperative sore throat. All tests will be two-sided with a significance level of 0.05.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

结局指标

主要结局

Proportion of Patients With Initial Endotracheal Tube Cuff Pressure Within 20-30 cmH2O

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

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.

次要结局

  • 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.)

研究者

发起方
Yusuf YILMAZ
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Yusuf YILMAZ

Principal Investigator; Specialist in Anesthesiology and Reanimation

Kayseri City Hospital

研究点 (1)

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