Continuous Endotracheal Tube Cuff Pressure Monitoring

Completed

• Conditions: Postoperative Complications Related to Endotracheal Intubation
• Interventions: Device: Endotracheal tube cuff pressure monitoring

• Registration Number: NCT06043648
• Lead Sponsor: Cukurova University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Primary Completion: 2023-06-15
• Study Completion: 2023-07-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Constant monitoring	Endotracheal tube cuff pressure monitoring	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.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative dysphagia	Postoperative 2 and 24 hours	The incidence of endotracheal tube-related complication defined as dysphagia during postoperative 2 and 24 hours.
Incidence of postoperative sore throat	Postoperative 2 and 24 hours	The incidence of endotracheal tube-related complication defined as sore throat during postoperative 2 and 24 hours.
Incidence of postoperative hoarseness	Postoperative 2 and 24 hours	The incidence of endotracheal tube-related complication defined as hoarseness during postoperative 2 and 24 hours.

Secondary Outcome Measures

Name	Time	Method
Identification of predictive factors related to endotracheal tube-related complications	During postoperative 24 hours	Identification of patient and operative characteristics and mechanical ventilation related factors that influence ETT-related complications.

Trial Locations

Locations (1)

Çukurova University; Faculty of Medicine; 🇹🇷 Adana, Sarıçam, Turkey