Inflation-deflation Method for Nasal Intubation in Pediatric Patients

Not Applicable

• Conditions: Nasal Intubation
• Interventions: Procedure: cuff deflation-inflation -deflation method

• Registration Number: NCT04038762
• Lead Sponsor: Suez Canal University

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.

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 Timeline

• Study Start: 2019-06-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-28
• Last Update Submitted: 2019-07-28
• Study First Posted: 2019-07-31
• Last Update Posted: 2019-07-31
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasotracheal Intubation with cuff inflation-deflation method	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
Conventional nasal intubation	cuff deflation-inflation -deflation method	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

Primary Outcome Measures

Name	Time	Method
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	during nasal intubation : 60 seconds	The percentage of patients who did not require Magill forceps for nasal intubation success was recorded.

Secondary Outcome Measures

Name	Time	Method
The time period for the second phase nasal intubation	60 seconds	The time in seconds for the second phase nasal intubation
The number of attempts required for successful nasal intubation.	120 seconds	number of trials, how many numbers of attempts the investigator take for successful nasal intubation
Amount of injected air for cuff inflation	15 seconds	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
Assessment of side effects of using Magill forceps during nasal intubation	Intraoperative and in the first 48 postoperative hours]	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)
evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.	20 minutes after complete recovery of patients	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
Evaluation of oxygenation state during nasal intubation	preoperative and intraoperative	rate of oxygen drop during the procedure

Trial Locations

Locations (1)

Tarek F.Tammam; 🇪🇬 Cairo, Egypt