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Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty

Primary Purpose

Rhinoplasty

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Suction Above Cuff Endotracheal Tube
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rhinoplasty focused on measuring general anesthesia, laryngospasm, postoperative complications, rhinoplasty, Suction Above Cuff Endotracheal Tube

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Van yuzuncu Yıl University, Dursun Odabas Medical Center
  • Van yuzuncu Yıl University, Dursun Odabas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group SA

Group C

Arm Description

Group SA intubated with Suction Above Cuff Endotracheal Tube

Group C intubated with classic endotracheal tube

Outcomes

Primary Outcome Measures

Incidence of laryngospasm
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

emergence agitation
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)

Full Information

First Posted
June 19, 2018
Last Updated
December 1, 2018
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT03584503
Brief Title
Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty
Official Title
Effect of the Use of Endotracheal Tube With Subglottic Suction on Laryngospasm and Postoperative Complications in Rhinoplasty Operations
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoplasty
Keywords
general anesthesia, laryngospasm, postoperative complications, rhinoplasty, Suction Above Cuff Endotracheal Tube

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized prospective controlled study
Masking
Participant
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group SA
Arm Type
Active Comparator
Arm Description
Group SA intubated with Suction Above Cuff Endotracheal Tube
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Group C intubated with classic endotracheal tube
Intervention Type
Other
Intervention Name(s)
Suction Above Cuff Endotracheal Tube
Intervention 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
Primary Outcome Measure Information:
Title
Incidence of laryngospasm
Description
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.
Time Frame
1 mounth
Secondary Outcome Measure Information:
Title
emergence agitation
Description
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)
Time Frame
1 mounth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nureddin Yüzkat, Assis prof
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Study Chair
Facility Information:
Facility Name
Van yuzuncu Yıl University, Dursun Odabas Medical Center
City
Van
ZIP/Postal Code
65080
Country
Turkey
Facility Name
Van yuzuncu Yıl University, Dursun Odabas Medical Center
City
Van
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27788682
Citation
Mao Z, Gao L, Wang G, Liu C, Zhao Y, Gu W, Kang H, Zhou F. Subglottic secretion suction for preventing ventilator-associated pneumonia: an updated meta-analysis and trial sequential analysis. Crit Care. 2016 Oct 28;20(1):353. doi: 10.1186/s13054-016-1527-7.
Results Reference
result
PubMed Identifier
24270899
Citation
Carter EL, Duguid A, Ercole A, Matta B, Burnstein RM, Veenith T. Strategies to prevent ventilation-associated pneumonia: the effect of cuff pressure monitoring techniques and tracheal tube type on aspiration of subglottic secretions: an in-vitro study. Eur J Anaesthesiol. 2014 Mar;31(3):166-71. doi: 10.1097/EJA.0000000000000009.
Results Reference
result
PubMed Identifier
18315632
Citation
Alalami AA, Ayoub CM, Baraka AS. Laryngospasm: review of different prevention and treatment modalities. Paediatr Anaesth. 2008 Apr;18(4):281-8. doi: 10.1111/j.1460-9592.2008.02448.x.
Results Reference
result
PubMed Identifier
31114211
Citation
Yuzkat N, Demir CY. Effect of using the Suction Above Cuff Endotracheal Tube (SACETT) on postoperative respiratory complications in rhinoplasty: a randomized prospective controlled trial. Ther Clin Risk Manag. 2019 Apr 17;15:571-577. doi: 10.2147/TCRM.S200662. eCollection 2019.
Results Reference
derived

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Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty

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