Completed

NCT Number: NCT06043648

Continuous Endotracheal Tube Cuff Pressure Monitoring

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.

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Key information

Conditions

Postoperative Complications Related to Endotracheal Intubation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Çukurova University; Faculty of Medicine

Adana, Sarıçam, 01330, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal tube cuff pressure monitoring

Device

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.

Primary outcomes

Incidence of postoperative sore throat

Time frame: 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

Time frame: Postoperative 2 and 24 hours

The incidence of endotracheal tube-related complication defined as hoarseness during postoperative 2 and 24 hours.
Incidence of postoperative dysphagia

Time frame: Postoperative 2 and 24 hours

The incidence of endotracheal tube-related complication defined as dysphagia during postoperative 2 and 24 hours.

Secondary outcomes

Identification of predictive factors related to endotracheal tube-related complications

Time frame: During postoperative 24 hours

Identification of patient and operative characteristics and mechanical ventilation related factors that influence ETT-related complications.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Sep 21, 2023
Registry last updated: Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.