Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging

NCT04730362 | Completed

• 1 other identifier: AP2007-50111
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study compare the effects of Oral airway vs LMA in preventing anesthesia-induced partial airway obstruction, in an attempt to lessen MRI motion artifacts, which would result in improvements in image quality.

Conditions

Airway Obstruction

Outcome Measures

Primary Outcomes (1)

• Image quality of each MRI sequence

  Image quality of each MRI sequence is evaluated by using a scoring system with the following scores: score of 1 (non-diagnostic), score of 2 (poor quality but some diagnostic value), score of 3 (average), score of 4 (good), and score of 5 (excellent).

  During general anesthesia of MRI investigation procedure

Study Arms (2)

Control group

ACTIVE COMPARATOR

20 patients in which a Guedel oral airway will be inserted for airway management and to conduct inhalational anesthetic through face mask fixed with harness to the head and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% .

Device: guedel airway; Drug: propofol bolus and then anesthesia sevoflurane

supraglottic group

ACTIVE COMPARATOR

20 patients in which supraglottic airway laryngeal mask airway (LMA) will be used and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% .

Device: supraglottic airway; Drug: propofol bolus and then anesthesia sevoflurane

Interventions

guedel airway DEVICE

Anesthesia will be conducted by induction with 1-2 • Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%. The goal is to maintain the patient spontaneous ventilation throughout the procedure. Monitoring of the patients is done by MRI compatible pulse oximetry for heart rate and oxygen saturation which is connected to MRI control room.

Control group

supraglottic airway DEVICE

supraglottic airway

supraglottic group

propofol bolus and then anesthesia sevoflurane DRUG

Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%

Control group; supraglottic group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ASA І and II patients
• Age under 18 years .
• The patient will need GA and patient Scheduled for MRI brain.

You may not qualify if:

• Glasgow coma scale ≤ 8
• Emergency patient with full stomach.
• Distorted upper airway anatomy making intubation with GA mandatory.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Nataional Cancer Instituite

Cairo, Egypt

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohammed Abdelfattah Abdelwadod

Model Details: Control group : a Guedel oral airway will be inserted for airway management versus supraglottic group patients in which supraglottic airway laryngeal mask airway (LMA) will be used

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: February 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

EG (1)