Clinical trial NCT06043648: Continuous Endotracheal Tube Cuff Pressure Monitoring
Official title: The Role of Continuous Endotracheal Tube Cuff Pressure Monitoring With a Simple Method in the Incidence of Endotracheal Tube-related Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications Related to Endotracheal Intubation
Keywords: cuffed endotracheal tube, intracuff pressure, pressure transducer
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients scheduled for elective non-head-neck surgical procedures under N2O-free general anesthesia and orally intubated with a cuffed endotracheal tube facilitated by neuromuscular blockers.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postoperative sore throat
timeFrame: Postoperative 2 and 24 hours
measure: Incidence of postoperative hoarseness
timeFrame: Postoperative 2 and 24 hours
measure: Incidence of postoperative dysphagia
timeFrame: Postoperative 2 and 24 hours
Secondary outcomes:
measure: Identification of predictive factors related to endotracheal tube-related complications
timeFrame: During postoperative 24 hours
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova University; Faculty of Medicine
state: Sarıçam
Study officials:
affiliation: Çukurova University, Balcalı Hospital
name: Demet Laflı Tunay, Dr.
role: PRINCIPAL_INVESTIGATOR
References: