Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty

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

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-10-30

Brief Summary

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Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. In this study, we aimed to investigate the effect of the use of SACETT on laryngospasm and postoperative complications in rhinoplasty operations. This randomized controlled clinical trial was conducted in 132 patients undergoing rhinoplasty.

The investigators believe that the use of SACETT in rhinoplasty operations reduces the incidences of laryngospasm, emergence agitation, sore throat, swallowing difficulty, and PONV when compared with classic endotracheal tube.

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Detailed Description

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Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. In this study, the investigators aimed to investigate the effect of the use of SACETT on laryngospasm and postoperative complications in rhinoplasty operations.

This randomized controlled clinical trial was conducted in 132 patients undergoing rhinoplasty. The patients were randomly divided into 2 groups: Suction Above Cuff Endotracheal Tube (n:66) (Group SA) and classic endotracheal tube (n:66) (Group C). Complications following general anesthesia were statistically analyzed among the two groups.

55 male patients and 77 female patients were included in the study. The incidences of postoperative laryngospasm and respiratory complications were found to be lower in Group SA compared to Group C. In addition, the incidences of agitation, postoperative nausea and vomiting (PONV), swallowing difficulty, and sore throat were found to be lower in Group SA compared to Group C. However, the incidences of cough, hypotension, and tachycardia were similar in both groups. No PONV, swallowing difficulty, and hypotension were observed in Group SA. The blood volume accumulated in the suction chamber was found to be greater in Group SA compared to Group C.

The investigators believe that the use of SACETT in rhinoplasty operations reduces the incidences of laryngospasm, emergence agitation, sore throat, swallowing difficulty, and PONV when compared with classic endotracheal tube.

Conditions

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Rhinoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized prospective controlled study

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Group SA

Group SA intubated with Suction Above Cuff Endotracheal Tube

Group Type ACTIVE_COMPARATOR

Suction Above Cuff Endotracheal Tube

Intervention Type OTHER

Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space

Group C

Group C intubated with classic endotracheal tube

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Suction Above Cuff Endotracheal Tube

Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who will undergo rhinoplasty surgery,
* American Society of Anesthesiologists (ASA) I-II patients,
* Aged 18-65 years

Exclusion Criteria

* Patients who had upper or lower respiratory tract infections,
* asthma,
* a history of allergy,
* who received isoflurane and desflurane for maintenance of anesthesia,
* who were the ASA class III-IV,
* and who had a long uvula,
* gastroesophageal reflux or sleep apnea,
* electrolyte disturbances such as hypomagnesemia and hypocalcemia,
* a BMI (body mass index) over 30 were excluded from the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No