Continuous Endotracheal Tube Cuff Pressure Monitoring

September 19, 2023 updated by: Demet Laflı Tunay, Cukurova University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sarıçam
      • Adana, Sarıçam, Turkey, 01330
        • Çukurova University; Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Postoperative 2 and 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
During postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cukurova University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Demet Laflı Tunay, Dr., Çukurova University, Balcalı Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CUFFP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data were anonymized by the local researcher. Therefore, data collection was pseudonymous and the patient's name did not appear on any case report form or other study document. All collected data were kept confidential. This study was conducted in accordance with the revision of the Declaration of Helsinki (2008). ICH-GCP was strictly adhered to.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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