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Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty

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ClinicalTrials.gov Identifier: NCT03584503
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Nureddin YUZKAT, Yuzuncu Yıl University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Rhinoplasty Other: Suction Above Cuff Endotracheal Tube Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized prospective controlled study
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effect of the Use of Endotracheal Tube With Subglottic Suction on Laryngospasm and Postoperative Complications in Rhinoplasty Operations
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

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



Primary Outcome Measures :
  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 Outcome Measures :
  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)




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584503


Locations
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Turkey
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, Turkey, 65080
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, Turkey
Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
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Study Chair: Nureddin Yüzkat, Assis prof Yuzuncu Yıl University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nureddin YUZKAT, Assistant professor, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03584503     History of Changes
Other Study ID Numbers: SACETT
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nureddin YUZKAT, Yuzuncu Yıl University:
general anesthesia
laryngospasm
postoperative complications
rhinoplasty
Suction Above Cuff Endotracheal Tube

Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes