Tracheal Tube Cuff Inflation-Deflation Method for Video Assisted Laryngoscope Nasal Intubation in Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorSuez Canal University
About this trial
The goal of this clinical trial is to compare cuff inflation deflation method versus conventional method using Magill forceps in adult patients scheduled for elective surgery dental or maxillofacial that need nasal intubation. The study question:
Is cuff inflation deflation method for nasal intubation takes a short time than the conventional method using Magill forceps in adult patients scheduled for elective surgery dental or maxillofacial?
We will compare the inflation deflation technique with the Magill forceps technique for nasal intubation in adult patients to see if the inflation deflation technique will take less time and associated with less side effects like cuff perforation and mucosal injury.
Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status I-III
Scheduled for elective surgery (dental and maxillofacial) in need for nasal intubation.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Inflation-deflation technique
Procedure/SurgeryInflation-Deflation Technique: The tracheal tube cuff will be inflated with 15-20 ml of air (volume of air is depending on the level of larynx). Once the tip of ETT at the laryngeal inlet, the cuff of ETT will be deflated and advanced into the trachea.
Magill forceps technique
Procedure/SurgeryThe Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Inflation-Deflation GroupActive comparator 1 intervention
Group B: Magill Forceps GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The time period for the second phase of nasal intubation
The time in seconds for the second phase nasal intubation(from the tip of endotracheal tube will be placed in pharynx till it pass the vocal cords
Time frame
IntraoperaotiveSecondary outcomes
1
to test whether the inflation-deflation method would decrease the need for Magill forceps in video laryngoscopy assisted nasal intubation in pediatric patients compared with the conventional non-cuff inflation approach.
The percentage of patients who did not require Magill forceps for nasal intubation success was recorded.
Time frame
Intraoperaotive2
The number of attempts required for successful nasal intubation.
number of trials, how many numbers of attempts the investigator take for successful nasal intubation
Time frame
Intraoperaotive3
Amount of injected air for cuff inflation
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
Time frame
Intraoperaotive4
Assessment of side effects of using Magill forceps during nasal intubation
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)
Time frame
IntraoperaotiveSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov