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Inflation-deflation Method for Nasal Intubation in Pediatric Patients

S

Suez Canal University

Status

Unknown

Conditions

Nasal Intubation

Treatments

Procedure: cuff deflation-inflation -deflation method

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 2 patient groups

Conventional nasal intubation
Active Comparator group
Description:
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
Treatment:
Procedure: cuff deflation-inflation -deflation method
Nasotracheal Intubation with cuff inflation-deflation method
Experimental group
Description:
Nasotracheal intubation placed with video laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps
Treatment:
Procedure: cuff deflation-inflation -deflation method

Trial contacts and locations

1

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Central trial contact

Ghada A. Kamhawy, Lecturer; Tarek F. Tammam, Professor

Data sourced from clinicaltrials.gov

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