Clinical trial NCT04038762: Inflation-deflation Method for Nasal Intubation in Pediatric Patients
Official title: Tracheal Tube Cuff Inflation-deflation Method for Video Laryngoscope-assisted Nasal Intubation in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasal Intubation
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: during nasal intubation : 60 seconds
Secondary outcomes:
measure: The time period for the second phase nasal intubation
timeFrame: 60 seconds
measure: The number of attempts required for successful nasal intubation.
timeFrame: 120 seconds
measure: Amount of injected air for cuff inflation
timeFrame: 15 seconds
measure: Assessment of side effects of using Magill forceps during nasal intubation
timeFrame: Intraoperative and in the first 48 postoperative hours]
measure: Evaluation of oxygenation state during nasal intubation
timeFrame: preoperative and intraoperative
measure: evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.
timeFrame: 20 minutes after complete recovery of patients
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tarek F.Tammam
Study officials:
References: