NCT03903679

Brief Summary

The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists. The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

April 2, 2019

Last Update Submit

June 23, 2019

Conditions

Airway AspirationAirway Complication of Anesthesia

Keywords

Airway managementSeptal surgeryLaryngeal mask airwayEndotracheal tubePresence of tracheal blood

Outcome Measures

Primary Outcomes (1)

  • Presence of blood in trachea

    Presence of blood in trachea will be evaluated on a scale and it is defined as the level of presence of blood on glottis-trachea and distal trachea. (1 = no, 2 = mild, 3 = moderate, 4 = severe).

    From the time 2minutes after the septal surgery to the time of extubation

Secondary Outcomes (2)

  • Sore-throat

    From the time 10 minutes after awakening from anesthesia to the time 24 hours postoperatively

  • Oropharyngeal leak pressure

    From the time 2 minutes after anesthesia induction to the correction of inserted device 5 minutes after anesthesia induction

Study Arms (2)

Laryngeal mask airway

ACTIVE COMPARATOR

Patients will be maintained with laryngeal mask airway supreme during the septal surgery.

Device: Laryngeal mask airway

Endotracheal tube

SHAM COMPARATOR

Patients will be maintained with endotracheal tube during the septal surgery.

Device: Endotracheal tube

Interventions

Laryngeal mask airwayDEVICE

Patients will be maintained with laryngeal mask airway during the septal surgery.

Laryngeal mask airway
Endotracheal tubeDEVICE

Patients will be maintained with endotracheal tube during the septal surgery.

Endotracheal tube

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old,
  • American Society of Anesthesiologists I-II
  • Patients with elective nasal septum surgery.
  • Patients who agreed to participate with informed consent form.

You may not qualify if:

  • Under 18 years,
  • Over 65 years,
  • American Society of Anesthesiologists III-IV,
  • Patients with severe respiratory, hepatic or renal dysfunction,
  • Patients with history of allergy to anesthesia medications
  • Modified mallampati grade 4,
  • Thyromental distance \<65 mm,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Medical Faculty

Malatya, 44090, Turkey (Türkiye)

Location

Related Publications (2)

  • Mao S, Du X, Ma J, Zhang G, Cui J. A comparison between laryngeal mask airway and endotracheal intubation for anaesthesia in adult patients undergoing NUSS procedure. J Thorac Dis. 2018 Jun;10(6):3216-3224. doi: 10.21037/jtd.2018.05.74.

    PMID: 30069317BACKGROUND

  • Karaaslan E, Akbas S, Ozkan AS, Colak C, Begec Z. A comparison of laryngeal mask airway-supreme and endotracheal tube use with respect to airway protection in patients undergoing septoplasty: a randomized, single-blind, controlled clinical trial. BMC Anesthesiol. 2021 Jan 7;21(1):5. doi: 10.1186/s12871-020-01222-4.

    PMID: 33407130DERIVED

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Erol Karaaslan, Asst. Prof.

    Inonu University Medical Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Erol Karaaslan

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 4, 2019

Study Start

April 5, 2019

Primary Completion

June 1, 2019

Study Completion

June 8, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)