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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2024-02-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endotracheal Tube Cuff Pressure Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

keeping the endotracheal tube cuff pressure within a certain range

Intervention Type OTHER

The endotracheal tube cuff pressures of the study group patients were kept within the range of 20-25 cm H2O.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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measuring ETT cuff pressures with a manometer and continuous pressure monitor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No