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NCT Number: NCT03584503

Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty

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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Key information

Conditions

Rhinoplasty Laryngeal Diseases Laryngismus Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Tract Diseases Vocal Cord Dysfunction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van yuzuncu Yıl University, Dursun Odabas Medical Center, Van, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suction Above Cuff Endotracheal Tube

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2018
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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