Continuous Endotracheal Tube Cuff Pressure Monitoring

Study Overview
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Brief Summary
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Tracheal tube cuff pressure in the range of 20 to 30 cmH2O is considered safe, but it is quite common to encounter cuff pressure outside this range in patients with tracheal intubation. Moreover, objective cuff pressure measurement and monitoring are not routinely applied, especially in general anesthesia practice. Overinflation of the cuff can potentially impair tracheal mucosal blood flow. This may lead to various tracheal injuries such as mucosal inflammation, mucosal ischemia, tracheal ulceration, tracheal stenosis, tracheoesophageal fistula, and tracheal rupture. Conversely, inadequate cuff inflation can lead to inadequate ventilation and microaspiration. The importance of routine cuff pressure measurement and pressure adjustment to keep the pressure in the desired range is emphasized in preventing such side effects in intubated patients. Despite this recommendation for routine intracuff pressure measurement, the methods used to measure and monitor cuff pressure vary from subjective estimation techniques to objective measurements, and there is a lack of specific protocols and documents in the current literature. For this purpose, in this study, it was aimed to perform continuous cuff pressure measurement monitoring using the transducer of the invasive pressure monitoring device, which is routinely used in arterial or central venous pressure monitoring, and to test the effectiveness of this method in reducing cuff-related complications including sore throat, hoarseness, and dysphagia compared to the intermittent monitoring method.

Official Title
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The Role of Continuous Endotracheal Tube Cuff Pressure Monitoring With a Simple Method in the Incidence of Endotracheal Tube-related Complications

Conditions
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Postoperative Complications Related to Endotracheal Intubation

Intervention / Treatment
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* Device: Endotracheal tube cuff pressure monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age adult patients Elective non-head-neck surgical procedures under nitrous oxide (N2O)-free general anesthesia Patients orally intubated with a cuffed endotracheal tube facilitated by neuromuscular blockers Surgeries with neutral head-neck position Exclusion Criteria: Emergency surgery Laparoscopic surgery Head and neck surgeries including nose, mouth, pharynx, larynx and throat Surgeries with non-supine patient position Patients with preoperative sore throat, cough, hoarseness or dysphagia, history of smoking, asthma or COPD, severe cardiovascular disease, inability to obtain consent, having any lesions detected in the pharynx or larynx during laryngoscopy Use of double lumen tracheal tube Use of a naso- or orogastric tube or any pharyngeal catheter Intraoperative nitrous oxide use Difficult intubation or repeated endotracheal intubation attempt Patients who strain during endotracheal extubation High PEEP (greater than 5 cmH2O) application

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Constant monitoring<br>Intracuff pressure was monitored continuously throughout the surgery using the transducer of the invasive pressure monitoring device in patients undergoing elective non-head-neck surgical procedures under general anesthesia and orally intubated with a cuffed endotracheal tube. | Device: Endotracheal tube cuff pressure monitoring<br>* The endotracheal tube cuff pressure was continuously monitored using a transducer from a standard invasive pressure monitoring device that is routinely used to measure arterial or central venous pressure.<br>|
| Intermittent monitoring<br>Intracuff pressure was monitored intermittently throughout the surgery using an analogue manometer in patients undergoing elective non-head-neck surgical procedures under general anesthesia and orally intubated with a cuffed endotracheal tube. | |
| None monitoring<br>After endotracheal intubation with a cuffed endotracheal tube, the cuff was inflated by the anesthesia provider using sealing pressure technique which involves slow inflation of the cuff until there is no audible gas leak while holding continuous positive airway pressure of 20 cmH2O with the head and neck in the neutral position. No other intracuff pressure monitoring or measurement was performed throughout the operation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative sore throat | The incidence of endotracheal tube-related complication defined as sore throat during postoperative 2 and 24 hours. | Postoperative 2 and 24 hours | 
| Incidence of postoperative hoarseness | The incidence of endotracheal tube-related complication defined as hoarseness during postoperative 2 and 24 hours. | Postoperative 2 and 24 hours | 
| Incidence of postoperative dysphagia | The incidence of endotracheal tube-related complication defined as dysphagia during postoperative 2 and 24 hours. | Postoperative 2 and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of predictive factors related to endotracheal tube-related complications | Identification of patient and operative characteristics and mechanical ventilation related factors that influence ETT-related complications. | During postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cuffed endotracheal tube, intracuff pressure, pressure transducer