Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty

December 1, 2018 updated by: Nureddin YUZKAT, Yuzuncu Yıl University

Effect of the Use of Endotracheal Tube With Subglottic Suction on Laryngospasm and Postoperative Complications in Rhinoplasty Operations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

132

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
      • Van, Turkey
        • Van Yüzüncü Yıl University, Dursun Odabaş Medical Center
      • Van, Turkey, 65080
        • Van Yüzüncü Yıl University, Dursun Odabaş Medical Center

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group SA
Group SA intubated with Suction Above Cuff Endotracheal Tube
Other: 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
NO_INTERVENTION: Group C
Group C intubated with classic endotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of laryngospasm
Time Frame: 1 mounth
While the presence of findings such as apnea (an apneic event was counted by either documentation of apnea by nursing notes through visual observation or documented pauses ≥15 s), desaturation (peripheral oxygen saturation <85%) and inspiratory stridor (Stridor is a harsh, vibratory sound of variable pitch caused by partial obstruction of the respiratory passages that results in turbulent airflow through the airway) after extubation was considered as laryngospasm.
1 mounth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emergence agitation
Time Frame: 1 mounth

Riker Sedation-Agitation Scale Score ≥5 (7-Dangerous agitation: Pulling at endotracheal tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side 6- Very agitated: Does not calm despite frequent verbal reminding of limits, requires physical restraints, biting endotracheal tube 5- Agitated: Anxious or mildly agitated, attempting to sit up, calms down on verbal instructions 4- Calm cooperative: Calm, easily arousable, follows commands 3- Sedated: Difficult to arouse, awakens to verbal stimuli or gentle shaking but drifts off again, follows simple commands 2- Very sedated: Arouses to physical stimuli but does not communicate or follow commands, may move spontaneously

1- Unarousable: Minimal or no response to noxious stimuli, does not communicate or follow command)
1 mounth

Collaborators and Investigators

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

Sponsor

Yuzuncu Yıl University

Investigators

  • Study Chair: Nureddin Yüzkat, Assis prof, Yuzuncu Yıl University

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)

June 1, 2018

Primary Completion (ACTUAL)

October 30, 2018

Study Completion (ACTUAL)

October 30, 2018

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

June 28, 2018

First Posted (ACTUAL)

July 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 1, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SACETT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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