The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range

April 4, 2024 updated by: Kheyrana Mahmudova, Hacettepe University

The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range on the Incidence of Post-surgery Cough, Sore Throat, Hoarseness.

The main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation duration, smoking, presence of chest disease, presence of blood on the intubation tube after extubation, presence of NG\OG, and type of surgery on the incidence of sore throat, hoarseness, and cough.The patients were randomly divided into two: a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoring.The endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation, before extubation, and in long cases, at the 3rd hour after intubation.Patients were evaluated for sore throat, cough, and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although the safe cuff pressure range for high volume-low pressure tubes used today is defined as 20-30 cmH2O, routine cuff pressure monitoring is not performed in operating rooms. The aim of this study is to investigate whether there is a significant pressure difference between blindly inflated cuffs and the cuffs inflated by controlling the cuff pressure aided by monitorization, and the effects of any detected pressure difference on the trachea using the clinically detectable parameters of sore throat, hoarseness and cough. The patients included in this prospective, controlled, randomized, double-blind study were divided into two groups: the study group whose cuff pressures were monitored continously (n = 163) and the control group (n = 100). The study group was constantly monitored with an invasive pressure monitoring system. In addition, a researcher who was blind to the groups measured the endotracheal tube cuff pressure with the help of a manometer after intubation in both groups, before extubation, and in long-term cases, at the 3rd hour after intubation. Postoperatively, patients were evaluated for sore throat, cough, and hoarseness using VAS scoring at the 2nd and 24th hour by another researcher blinded to the study groups. Statistical evaluation was made using the Statistical Package for Social Sciences for Windows 20 (SPSS-IBM SPSS Inc., Chicago, IL) program. Complaint of sore throat was observed significantly less at 2nd and 24th hours in the group with cuff pressure monitoring (p=0.00 for 2nd hour sore throat, p=0.02 for 24th hour sore throat). No difference was detected between the groups in terms of hoarseness and cough. It has been observed that manometer measurements also reduce the pressure due to the use of air in the same closed system. The quantity of this reduction, which some researchers have previously stated, needs to be studied in more detail. In conclusion, intraoperative ETT cuff pressure monitoring may be effective in preventing sore throat and the mucosal ischemia that causes this pain.

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Not Applicable

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
      • Ankara, Turkey, 06100
        • Hacettepe University Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA ( american society of anesthesiologists) I-II-III group patients
  • elective surgery
  • surgery under general anesthesia
  • gynecology and obstetrics and general surgery

Exclusion Criteria:

  • Patients who did not agree to participate in the study,
  • Patients under 18 years of age,
  • Patients with ASA IV, V, VI,
  • Patients scheduled for emergency surgery,
  • Patients for whom difficult intubation is anticipated
  • Patients who could not be intubated on the first try.
  • Patients with tracheostomy
  • Thyroidectomy operations
  • Parathyroidectomy operations
  • COPD (Chronic Obstructive Pulmonary Disease) patients who have had an attack in the last 6 months
  • Patients who complain of sore throat, hoarseness and cough before surgery.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
The endotracheal tubes of the control group were placed and inflated by the caregiver. A seperate blinded researcher measured cuff pressures by manometer but did not inform the team and no intervention was made.
Active Comparator: study group
The endotracheal tube cuff pressures of the study group patients were constantly monitored and kept within the range of 20-25 cm H2O.
Other: keeping the endotracheal tube cuff pressure within a certain range
The endotracheal tube cuff pressures of the study group patients were kept within the range of 20-25 cm H2O.
Other Names:
  • measuring ETT cuff pressures with a manometer and continuous pressure monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sore throat
Time Frame: second and 24th hours postoperatively
Blinded researcher using VAS (The Visual Analogue Scale) score to evaluate patient discomfort level.0-no pain, score <3 mild pain, 3-6 moderate pain, and >6 severe pain
second and 24th hours postoperatively
cough
Time Frame: second and 24th hours postoperatively
Blinded researcher using yes/no to evaluate patient discomfort. yes means the patient has a cough, no means she/he does not
second and 24th hours postoperatively
hoarseness
Time Frame: second and 24th hours postoperatively
Blinded researcher using yes/no to evaluate patient discomfort. yes means the patient has hoarseness, no means she/he does not
second and 24th hours postoperatively

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Murat İzgi, Ass. Prof., Hacettepe University Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 25, 2024

Primary Completion (Actual)

February 25, 2024

Study Completion (Actual)

February 25, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-23026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All checked supporting information is available, stored by the investigators. If

IPD Sharing Time Frame

All data will be kept for a year after the completion of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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