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

Primary Purpose

Airway Obstruction

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
guedel airway
supraglottic airway
propofol bolus and then anesthesia sevoflurane
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Airway Obstruction

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Nataional Cancer Instituite

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

supraglottic group

Arm Description

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% .

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% .

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 26, 2021
Last Updated
April 29, 2022
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04730362
Brief Title
Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging
Official Title
Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

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
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.
Detailed Description
Magnetic resonance image (MRI) is a frequently used imaging technique especially in oncological patients, where it is used for diagnosis, following up response to treatment and later for detection of possible recurrence. The main problem encountered with MRI is the long time required for completion of the imaging, during which the patient is required to lie still. Patients who are unable to lie still require sedation or general anesthesia (GA). Almost all pediatric patients are uncooperative, making GA, the standard of care for pediatric MRI. Several general anesthetic techniques including airway management by endotracheal tube & various supraglottic devices (LMA) have been described. Choice of technique by anesthesiologist is influenced by the patient's age, craniofacial and airway anatomy, procedure duration, & illness acuity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigator
Masking Description
Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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% .
Arm Title
supraglottic group
Arm Type
Active Comparator
Arm Description
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% .
Intervention Type
Device
Intervention Name(s)
guedel airway
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
supraglottic airway
Intervention Description
supraglottic airway
Intervention Type
Drug
Intervention Name(s)
propofol bolus and then anesthesia sevoflurane
Intervention Description
Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%
Primary Outcome Measure Information:
Title
Image quality of each MRI sequence
Description
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).
Time Frame
During general anesthesia of MRI investigation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA І and II patients Age under 18 years . The patient will need GA and patient Scheduled for MRI brain. Exclusion Criteria: Glasgow coma scale ≤ 8 Emergency patient with full stomach. Distorted upper airway anatomy making intubation with GA mandatory.
Facility Information:
Facility Name
Nataional Cancer Instituite
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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