Modified Magill Forceps Facilitating Nasal Intubation for... | NCT05513989

Studies
Modified Magill Forceps Facilitating Nasal Intubation for Children Undergoing Dental Operations

NCT05513989

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Aug 24, 2022Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Interventions

modified Magill forceps
Magill forceps

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Estimated

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Aug 16, 2022

First Submission Date that Met QC Criteria

Aug 23, 2022

First Posted Date

Aug 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2022

Last Update Posted Date

Aug 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

compare between Magill forceps and modified pediatric Magill forceps for nasotracheal intubation (which method is easier and better?).

Detailed Description

Group A One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation.

Group B One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation.

For each patient, intubation time, number of intubation attempts, hypoxia (recognized when oxygen saturation decreases below 94%), pharyngeal trauma, and need for corkscrewing will be recorded.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
modified Magill forceps group	Active Comparator	One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation	Device: modified Magill forceps
Magill forceps group	Active Comparator	One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation.	Device: Magill forceps

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modified Magill forceps	Device	modified pediatric Magill forceps was used to assist nasotracheal intubation.	modified Magill forceps group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intubation time		just after anesthesia induction for 30 minutes

Secondary Outcomes

Measure	Description	Time Frame
number of intubation attempts		after anesthesia induction for 30 minutes
hypoxia		after anesthesia induction for 30 minutes
pharyngeal trauma

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with the American Society of Anesthesiology physical status of 1 or 2
Age 4 to 8 years old.
Elective dental surgeries.

Exclusion Criteria:

Parental refusal to consent (absolute contraindication),
Patients with aspiration risk.
Known upper airway abnormalities.
Those having difficult airway.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams university		Cairo		20	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided