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

NCT ID: NCT04730362

Last Updated: 2022-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-03-01

Brief Summary

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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

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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.

Conditions

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Airway Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope

Study Groups

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Control group

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% .

Group Type ACTIVE_COMPARATOR

guedel airway

Intervention Type 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.

propofol bolus and then anesthesia sevoflurane

Intervention Type DRUG

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

supraglottic group

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% .

Group Type ACTIVE_COMPARATOR

supraglottic airway

Intervention Type DEVICE

supraglottic airway

propofol bolus and then anesthesia sevoflurane

Intervention Type DRUG

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

Interventions

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guedel airway

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

supraglottic airway

supraglottic airway

Intervention Type DEVICE

propofol bolus and then anesthesia sevoflurane

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Abdelfattah Abdelwadod

Mohammed Abdelfattah Abdelwadod

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nataional Cancer Instituite

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP2007-50111

Identifier Type: -

Identifier Source: org_study_id

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