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Continuous Endotracheal Tube Cuff Pressure Monitoring

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06043648
Enrollment
195
Registered
2023-09-21
Start date
2022-09-15
Completion date
2023-07-01
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications Related to Endotracheal Intubation

Keywords

cuffed endotracheal tube, intracuff pressure, pressure transducer

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.

Interventions

DEVICEEndotracheal tube cuff pressure monitoring

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.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative sore throatPostoperative 2 and 24 hoursThe incidence of endotracheal tube-related complication defined as sore throat during postoperative 2 and 24 hours.
Incidence of postoperative hoarsenessPostoperative 2 and 24 hoursThe incidence of endotracheal tube-related complication defined as hoarseness during postoperative 2 and 24 hours.
Incidence of postoperative dysphagiaPostoperative 2 and 24 hoursThe incidence of endotracheal tube-related complication defined as dysphagia during postoperative 2 and 24 hours.

Secondary

MeasureTime frameDescription
Identification of predictive factors related to endotracheal tube-related complicationsDuring postoperative 24 hoursIdentification of patient and operative characteristics and mechanical ventilation related factors that influence ETT-related complications.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026