NCT04038762

Brief Summary

Magill forceps is used to maneuver the endotracheal tube ETT in the posterior oropharynx and place its tip into the laryngeal inlet. While the Magill forceps are useful in guiding the nasotracheal tube past the vocal cords, care must be taken to avoid excessive maneuvering in order to minimize the risk of local trauma and rupture of the nasotracheal tube balloon. Cuff inflation-deflation method can reduce the apnea time in the pediatric patients, a population with known physiological limitations in respiratory reserve. This, in turn, could point to a reduction in the complications (as desaturation and cardiac arrhythmia) that associated with the prolonged-time procedure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

July 22, 2019

Last Update Submit

July 28, 2019

Conditions

Nasal Intubation

Outcome Measures

Primary Outcomes (1)

  • to test whether the inflation-deflation method (pre-cuff inflation) would decrease the need for Magill forceps in video laryngoscopy assisted nasal intubation in pediatric patients compared with the conventional non-cuff inflation approach. T

    The percentage of patients who did not require Magill forceps for nasal intubation success was recorded.

    during nasal intubation : 60 seconds

Secondary Outcomes (6)

  • The time period for the second phase nasal intubation

    60 seconds

  • The number of attempts required for successful nasal intubation.

    120 seconds

  • Amount of injected air for cuff inflation

    15 seconds

  • Assessment of side effects of using Magill forceps during nasal intubation

    Intraoperative and in the first 48 postoperative hours]

  • Evaluation of oxygenation state during nasal intubation

    preoperative and intraoperative

  • +1 more secondary outcomes

Study Arms (2)

Conventional nasal intubation

ACTIVE COMPARATOR

Passage of an endotracheal tube via the nare followed by video laryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps

Procedure: cuff deflation-inflation -deflation method

Nasotracheal Intubation with cuff inflation-deflation method

EXPERIMENTAL

Nasotracheal intubation placed with video laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps

Procedure: cuff deflation-inflation -deflation method

Interventions

cuff deflation-inflation -deflation methodPROCEDURE

Nasotracheal intubation placed with video-laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps

Also known as: pre-cuff inflation
Conventional nasal intubationNasotracheal Intubation with cuff inflation-deflation method

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I-II,
  • Scheduled for elective surgery (dental and maxillofacial) in need for nasal intubation.

You may not qualify if:

  • Patients, who have coagulopathies,
  • Have upper airway abnormalities,
  • At risk for aspiration or by reasons of
  • Parent's refusal will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarek F.Tammam

Cairo, 12311, Egypt

RECRUITING

Central Study Contacts

Tarek F. Tammam, Professor

CONTACT

00201280871947tarek1367@hotmail.com

Ghada A. Kamhawy, Lecturer

CONTACT

00201224737320gkamhawy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tarek F.Tammam,M.D,Ph.D,Department of Anesthesia and intendive care,Faculty of Medicine.

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 31, 2019

Study Start

June 1, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)