Inflation-deflation Method for Nasal Intubation in Pediatric Patients

NCT ID: NCT04038762

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-01-31

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.

Conditions

Nasal Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

cuff deflation-inflation -deflation method

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

cuff deflation-inflation -deflation method

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

pre-cuff inflation

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Tarek F.Tammam

Tarek F.Tammam,M.D,Ph.D,Department of Anesthesia and intendive care,Faculty of Medicine.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tarek F.Tammam

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Tarek F. Tammam, Professor

Role: CONTACT

Phone: 00201280871947

Email: tarek1367@hotmail.com

Ghada A. Kamhawy, Lecturer

Role: CONTACT

Phone: 00201224737320

Email: gkamhawy@yahoo.com

Facility Contacts

Tarek F. Tammam, Professor

Role: primary

Ghada A. Kamhawy, Lecturer

Role: backup

Other Identifiers

Tammam

Identifier Type: -

Identifier Source: org_study_id