Skip to content

Inflation-deflation Method for Nasal Intubation in Pediatric Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04038762
Enrollment
90
Registered
2019-07-31
Start date
2019-06-01
Completion date
2020-01-31
Last updated
2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Intubation

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.

Interventions

PROCEDUREcuff 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

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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. Tduring nasal intubation : 60 secondsThe percentage of patients who did not require Magill forceps for nasal intubation success was recorded.

Secondary

MeasureTime frameDescription
The number of attempts required for successful nasal intubation.120 secondsnumber of trials, how many numbers of attempts the investigator take for successful nasal intubation
Amount of injected air for cuff inflation15 secondsAmount of injected air in ml, how many air injected in the cuff balloon to make the tip of endotracheal tube advanced into the trachea
The time period for the second phase nasal intubation60 secondsThe time in seconds for the second phase nasal intubation
Evaluation of oxygenation state during nasal intubationpreoperative and intraoperativerate of oxygen drop during the procedure
evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.20 minutes after complete recovery of patientsscore 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
Assessment of side effects of using Magill forceps during nasal intubationIntraoperative 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)

Countries

Egypt

Contacts

Primary ContactTarek F. Tammam, Professor
tarek1367@hotmail.com00201280871947
Backup ContactGhada A. Kamhawy, Lecturer
gkamhawy@yahoo.com00201224737320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026