Comparison of the Audible Leak-balloon Palpation Method and the Stethoscope-guided Method for Endotracheal Tube Cuff Inflation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- cuff pressure of air introduced
研究概览
简要总结
The goal of this clinical trial is to test whether the stethoscope can be used as a method of assessing endotracheal cuff pressure as effectively as a manometer and also to compare it with the balloon palpation/audible leak method frequently used in clinical practice in adult patients undergoing general anesthesia.
The main questions it aims to answer are:
- Is the stethoscope as effective as a manometer in assessing endotracheal cuff pressure?
- Is there a difference between stethoscope and audible leak/balloon palpation methods in assessing endotracheal cuff pressure? Participants will be randomly divided into 2 groups.
- Group P: After intubation, endotracheal cuff pressure will be assessed by audible leak/balloon palpation.
- Group S: After intubation, endotracheal cuff pressure will be assessed with a stethoscope.
- Control will be carried out with a manometer and the pressure values obtained in the groups will be corrected.
Researchers will compare ''stethoscope'' and ''audible leak/balloon palpation'' groups to see if which method is effective like a manometer.
详细描述
Although the use of a manometer is recommended in daily practice to evaluate endotracheal tube cuff pressure for intubated patients, the cuff is still inflated using balloon palpation or audible leakage methods in many centers. Manometers may not be available in most centers. An acceptable cuff pressure ranges from 20 to 30 cm H2O. While the risk of aspiration increases below 20 cm H2O, at values above 30 cm H2O the circulation of the tracheal mucosa begins to deteriorate and related complications like ulceration, stenosis, and even fistula may develop.
The authors hypothesize that the stethoscope is as effective as a manometer in assessing endotracheal tube cuff pressure where a manometer is not available.
After informed consent is obtained from patients who meet the inclusion criteria for the study, the patients will be intubated following anesthesia induction and the method by which the patients' endotracheal tube cuffs will be inflated will be determined in a randomized manner using the sealed envelope method. Then, the cuff pressures will be checked with a manometer by an expert who does not know the method by which the cuff is inflated, if necessary, it will be corrected and the data will be recorded with the code assigned to the method. Statistical evaluations will be made on the data obtained by an analyst who does not know the names of the methods and which method was applied to which patient.
The difference between our study and previous studies:
- Previous studies had small numbers of patients.
- The authors designed a randomized controlled study with triple masking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the person who intubates the patient and inflates the cuff using a method will know what the procedure is.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 18-65
- •Planning the operation under general anesthesia
- •Performing endotracheal intubation during general anesthesia
- •Elective surgeries
- •Volunteering to participate in the study
排除标准
- •Having a history of difficult intubation before
- •Difficulty during intubation (repeated intubation attempts, etc.)
- •rapid sequence intubation requirement
- •Planning to undergo head and neck surgery
- •Those with tracheal stenosis
- •Previous intervention to the neck area (radiotherapy, tracheotomy, etc.)
- •Pregnancy
- •Those with respiratory diseases (COPD, asthma, etc.)
- •Emergency surgery
- •American Society of Anaesthesiologists physical status>3
- •Refusing to participate in the study
结局指标
主要结局
cuff pressure of air introduced
时间窗: After the patients are intubated and tube cuff inflated
After the cuffs inflated using the specified methods are checked with a manometer, it will be noted whether there is any difference between the required pressures (centimeter of water/cm H2O).
cuff volume of air introduced
时间窗: After the patients are intubated and tube cuff inflated
After the cuffs inflated using the specified methods are checked with a manometer, it will be noted whether there is any difference between the required additional volumes (milliliters/mL).
次要结局
- endotracheal tube diameters(After induction of anesthesia and intubation)
- endotracheal tube brands(After induction of anesthesia and intubation)
研究者
Mustafa Soner Ozcan
Assistant professor
Suleyman Demirel University