Inflation-deflation Method for Nasal Intubation in Pediatric Patients

Tracheal Tube Cuff Inflation-deflation Method for Video Laryngoscope-assisted Nasal Intubation in Pediatric Patients

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.

Study Overview

• Status: Unknown
• Conditions: Nasal Intubation
• Intervention / Treatment: Procedure: cuff deflation-inflation -deflation method

Detailed Description

the investigator will compare the cuff inflation-deflation method versus the conventional method of nasal intubation in pediatric patients for the need of using Magill forceps 90 pediatric patients between the ages of 3 and 12 years with the American Society of Anesthesiologists (ASA) physical status I-II, scheduled for elective surgery (dental and maxillofacial) will be enrolled in a prospectively randomized observer-blinded clinical trial. 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.

Airway management is subdivided into phases:

• Phase 1: Passage of the endotracheal tube through the nose into the pharynx
• Phase 2: Video-laryngoscope-guided passage of the endotracheal tube through the pharynx into the trachea.

Phase 2 can be performed with the tracheal tube cuff inflation-deflation method vs. non-cuff inflation method. A Magill forceps can be used to guide the endotracheal tube pass through the pharynx and glottis into the trachea if required.

Tracheal tube cuff inflation-deflation method: Tracheal tube cuff is inflated with a variable amount of air (volume of air is depending on the level of the larynx). Once the tip of endotracheal tube at the laryngeal inlet, the cuff of the endotracheal tube is deflated and advanced into the trachea

Patients included in the study will be assigned into two groups for the second phase of airway management:

Group A (n = 45) in whom nasal intubation will be performed using the cuff inflation-deflation method; and Group B (n = 45), in whom the nasal intubation will be performed using non-inflation method.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Recruiting
    • Tarek F.Tammam
    • Contact: Tarek F. Tammam, Professor; Phone Number: 00201280871947; Email: tarek1367@hotmail.com
    • Contact: Ghada A. Kamhawy, Lecturer; Phone Number: 00201224737320; Email: gkamhawy@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional nasal intubation; 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 placed with video-laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps; Other Names: pre-cuff inflation
Experimental: Nasotracheal Intubation with cuff inflation-deflation method; 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; Nasotracheal intubation placed with video-laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps; Other Names: pre-cuff inflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of attempts required for successful nasal intubation.	number of trials, how many numbers of attempts the investigator take for successful nasal intubation	120 seconds
Amount of injected air for cuff inflation	Amount of injected air in ml, how many air injected in the cuff balloon to make the tip of endotracheal tube advanced into the trachea	15 seconds
Evaluation of oxygenation state during nasal intubation	rate of oxygen drop during the procedure	preoperative and intraoperative
The time period for the second phase nasal intubation	The time in seconds for the second phase nasal intubation	60 seconds
Assessment of side effects of using Magill forceps during nasal intubation	A 4-point scale: 1- No epistaxis; 2-Mild epistaxis (blood on the tracheal tube only); 3- Moderate epistaxis (blood pooling in the pharynx); 4- Severe epistaxis (blood in the pharynx sufficient to impede intubation)	Intraoperative and in the first 48 postoperative hours]
evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.	score 1 to 5 A five-point Likert scales for: How likely is it that anesthetist would recommend the same used inflation-deflation method to practice a colleague in the future (not at all/ slightly/ moderately/ very/ extremely: where 1 is not at all, 3 is moderate,5 is extremely	20 minutes after complete recovery of patients

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 28, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 28, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Tammam

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No