Continuous Endotracheal Tube Cuff Pressure Monitoring

NCT ID: NCT06043648

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 195 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-07-01

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.

Conditions

Postoperative Complications Related to Endotracheal Intubation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Constant 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.

Endotracheal tube cuff pressure monitoring

Intervention Type: 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.

Intermittent monitoring

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.

No interventions assigned to this group

None monitoring

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.

No interventions assigned to this group

Interventions

Endotracheal 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Demet Laflı Tunay

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Demet Laflı Tunay, Dr.

Role: PRINCIPAL_INVESTIGATOR

Çukurova University, Balcalı Hospital

Locations

Çukurova University; Faculty of Medicine

Adana, Sarıçam, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CUFFP

Identifier Type: -

Identifier Source: org_study_id