Is LMA applicable in cochlear implant?

Comparing the effects and side effects of LMA and tracheal tube in children under general anesthesia for cochlear implantation.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013011512134N1

Enrollment

Registered

2013-01-20

Start date

2013-03-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: cochlear implant. Condition 2: Hearing Loss, Deafness. cochlear implant, Presence of otological and audiological implants Hearing Loss, Deafness

Interventions

Intervention 1: Intervention group: airway management with Laryngeal Mask Airway (LMA) without laryngoscpy at induction. Intervention 2: Control group: airway management with tracheal tube after laryn

Intervention group: airway management with Laryngeal Mask Airway (LMA) without laryngoscpy at induction

Control group: airway management with tracheal tube after laryngoscopy with McGill blade at induction

Eligibility

Sex/Gender

All

Age

3 Years to 17 Years

Inclusion criteria

Inclusion criteria: Inclusion: elective cochlear implant surgery; ASA class I,II; age between 3-17 year; parental consent. Exclusion criteria: upper airway infection; finding of difficult airway.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Airway Pressure. Timepoint: 15 minutes. Method of measurement: mm Hg.;End Tidal CO2. Timepoint: 15 minutes. Method of measurement: mm Hg, Capnography.;Arterial O2 Saturation SaO2. Timepoint: 15 minutes. Method of measurement: percent (%), Pulseoximetry.;Pulse Rate. Timepoint: 15 minutes. Method of measurement: Beat per Minute, Pulseoximetry, Electrocardiography.;Sore throat. Timepoint: In Post Anesthesia Care Unit and 24 hours post operation. Method of measurement: Asking patients, Visual Analog Scale.;Cough. Timepoint: In Post Anesthesia Care Unit and 24 hours post operation. Method of measurement: Observation, Absent or Present.;Bronchospasm/Wheezing. Timepoint: In Post Anesthesia Care Unit. Method of measurement: Physical Examination, Auscultation, Absent/Present.;Laryngospasm/ Desaturation. Timepoint: In Post Anesthesia Care Unit. Method of measurement: Physical Examination, Pulseoximetry, Absent/Present.;Vomiting. Timepoint: In Post Anesthesia Care Unit. Method of measurement: Observation, Absent or Present.;Cardiac Dysrhythmia. Timepoint: During Operation and in Post Anesthesia Care Unit. Method of measurement: Electrocardiogram, Absent/Present.	—

Measure

Time frame

Airway Pressure. Timepoint: 15 minutes. Method of measurement: mm Hg.;End Tidal CO2. Timepoint: 15 minutes. Method of measurement: mm Hg, Capnography.;Arterial O2 Saturation SaO2. Timepoint: 15 minutes. Method of measurement: percent (%), Pulseoximetry.;Pulse Rate. Timepoint: 15 minutes. Method of measurement: Beat per Minute, Pulseoximetry, Electrocardiography.;Sore throat. Timepoint: In Post Anesthesia Care Unit and 24 hours post operation. Method of measurement: Asking patients, Visual Analog Scale.;Cough. Timepoint: In Post Anesthesia Care Unit and 24 hours post operation. Method of measurement: Observation, Absent or Present.;Bronchospasm/Wheezing. Timepoint: In Post Anesthesia Care Unit. Method of measurement: Physical Examination, Auscultation, Absent/Present.;Laryngospasm/ Desaturation. Timepoint: In Post Anesthesia Care Unit. Method of measurement: Physical Examination, Pulseoximetry, Absent/Present.;Vomiting. Timepoint: In Post Anesthesia Care Unit. Method of measurement: Observation, Absent or Present.;Cardiac Dysrhythmia. Timepoint: During Operation and in Post Anesthesia Care Unit. Method of measurement: Electrocardiogram, Absent/Present.

—

Secondary

Measure	Time frame
Bleeding during surgery. Timepoint: 15 minutes. Method of measurement: Surgical field observation (grade 1 to 5).;Surgeon's Satisfaction of surgical Field. Timepoint: 15 minutes. Method of measurement: Asking Surgeon ( grade 1 to 3 ).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKamran Mottaghi

Shahid Beheshti University of Medical Sciences

k_mottaghi@sbmu.ac.ir; kmrnmtghi@yahoo.com+98 21 5542 4040

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026