Airway ManagementNCT05455723
Tracheal Tube Cuff Inflation-Deflation Method for Video Assisted Laryngoscope Nasal Intubation in Adults
A study testing Inflation-deflation technique and Magill forceps technique in people with Airway Management and Nasal Intubation, run by Suez Canal University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Airway Management, Nasal Intubation, Video Laryngoscope
- What is being tested?
- Inflation-deflation technique and Magill forceps technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective surgery (dental and maxillofacial) in need for nasal intubation.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Suez Canal University
Ismailia, 41522
Tarek F. Tammam, Professor, 00201280871947, tarek1367@hotmail.com
Aiman A. Al-Touny, Lecturer
About this study
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?
Read more
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].
Read the detailed description
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 adult patients. This, in turn, could point to a reduction in the complications (as desaturation and cardiac arrhythmia) that associated with the prolonged-time procedure.
Written informed consent will be obtained from all patients participating in the trial. The trial will be registered prior to patient enrollment. Ninety patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I -II , scheduled for elective surgery (dental and maxillofacial) will be enrolled in a prospective randomized observer blinded clinical trial. Patients, who have coagulopathies, have upper airway abnormalities, at risk for aspiration or patient's refusal will be excluded from the study.
Materials and methods
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.
Patients will be randomized into 2 groups according to phase 2:
Group A (45 patients) will be performed with tracheal tube cuff inflation-deflation method. 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.
Group 2 (45 patients) will be performed using the Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea.
Patients will be randomly assigned on a one-to-one ratio. Randomization will be performed outside the study center by means of a computer generated random- numbers table. Group allocation will be concealed in sealed opaque envelopes that will not be opened till the last practical moment.
The nasal intubation will be performed behind an opaque screen so that observer could not see which approach will be used. All procedures were performed preoperatively by the attending anesthetists, who have the same substantial expertise (at least 3 years) in the video laryngoscopy assisted nasal intubation in adult patients. Patient demographics, type and duration of surgery, and the patient's ASA physical status will be recorded.
- Conditions
- Airway Management, Nasal Intubation, Video Laryngoscope
- Being tested
- Inflation-deflation technique, Magill forceps technique
- Keywords
- Magill forceps, Inflation-deflation technique, Video-assisted Laryngoscope, Nasal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflation-deflation techniqueProcedure or surgery
Inflation-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 techniqueProcedure or surgery
The Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea.
| Study group | Role | What they receive |
|---|---|---|
| Inflation-Deflation Group | Active comparator | Group A (45 patients): Phase 2 of ETT intubation will be performed with tracheal tube cuff inflation-deflation method. 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. Receives: Procedure: Inflation-deflation technique |
| Magill Forceps Group | Active comparator | Group B (45 patients): Phase 2 of ETT intubation will be performed using the Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea. Receives: Procedure: Magill forceps technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intraoperaotive
Secondary outcomes (8)
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.
Measured: Intraoperaotive
The number of attempts required for successful nasal intubation.
number of trials, how many numbers of attempts the investigator take for successful nasal intubation
Measured: Intraoperaotive
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
Measured: Intraoperaotive
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)
Measured: Intraoperaotive
Evaluation of oxygenation state during nasal intubation
rate of oxygen drop during the procedure
Measured: preoperative and intraoperative
evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.
score 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
Measured: 20 minutes after patient recovery
Need for external compression and need for help
Need for external tracheal compression and need for help
Measured: Intraoperaotive
need of endotracheal tube rotation
need of endotracheal tube rotation and the degree of rotation 90, 180 0r 360 degree
Measured: Intraoperaotive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start19 Jan 2024
- Primary completion25 Feb 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiman Al-Touny, Suez Canal University
- Investigators
- Tarek F. Tammam, Professor, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455723
- Sponsor's protocol ID
- 4523#
- Status last verified
- Jan 2025
- First submitted
- 10 Jul 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Tube Cuff Inflation-Deflation Method for Video Assisted Laryngoscope Nasal Intubation in Adults
- ClinicalTrials.gov ID
- NCT05455723
- Acronym / sponsor ID
- 4523#
- Conditions
- Airway Management, Nasal Intubation, Video Laryngoscope
- Keywords
- Magill forceps, Inflation-deflation technique, Video-assisted Laryngoscope, Nasal intubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Detailed description
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 adult patients. This, in turn, could point to a reduction in the complications (as desaturation and cardiac arrhythmia) that associated with the prolonged-time procedure.
Written informed consent will be obtained from all patients participating in the trial. The trial will be registered prior to patient enrollment. Ninety patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I -II , scheduled for elective surgery (dental and maxillofacial) will be enrolled in a prospective randomized observer blinded clinical trial. Patients, who have coagulopathies, have upper airway abnormalities, at risk for aspiration or patient's refusal will be excluded from the study.
Materials and methods
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.
Patients will be randomized into 2 groups according to phase 2:
Group A (45 patients) will be performed with tracheal tube cuff inflation-deflation method. 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.
Group 2 (45 patients) will be performed using the Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea.
Patients will be randomly assigned on a one-to-one ratio. Randomization will be performed outside the study center by means of a computer generated random- numbers table. Group allocation will be concealed in sealed opaque envelopes that will not be opened till the last practical moment.
The nasal intubation will be performed behind an opaque screen so that observer could not see which approach will be used. All procedures were performed preoperatively by the attending anesthetists, who have the same substantial expertise (at least 3 years) in the video laryngoscopy assisted nasal intubation in adult patients. Patient demographics, type and duration of surgery, and the patient's ASA physical status will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflation-Deflation Group | Active comparator | Procedure: Inflation-deflation techniqueGroup A (45 patients): Phase 2 of ETT intubation will be performed with tracheal tube cuff inflation-deflation method. 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 Group | Active comparator | Procedure: Magill forceps techniqueGroup B (45 patients): Phase 2 of ETT intubation will be performed using the Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective surgery (dental and maxillofacial) in need for nasal intubation.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflation-deflation techniqueInflation-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. | Procedure or surgery | Inflation-Deflation Group |
| Magill forceps techniqueThe Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea. | Procedure or surgery | Magill Forceps Group |
Primary outcome
The time period for the second phase of nasal intubation
Time frame: Intraoperaotive
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
8 secondary outcomes
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.
Time frame: Intraoperaotive
The number of attempts required for successful nasal intubation.
Time frame: Intraoperaotive
Amount of injected air for cuff inflation
Time frame: Intraoperaotive
Assessment of side effects of using Magill forceps during nasal intubation
Time frame: Intraoperaotive
Evaluation of oxygenation state during nasal intubation
Time frame: preoperative and intraoperative
evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.
Time frame: 20 minutes after patient recovery
Need for external compression and need for help
Time frame: Intraoperaotive
need of endotracheal tube rotation
Time frame: Intraoperaotive
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tarek F. Tammam, Professor principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inflation-deflation technique and Magill forceps technique in people with Airway Management and Nasal Intubation, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarek F. Tammam, Professor (00201280871947, tarek1367@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time period for the second phase of nasal intubation (time frame: Intraoperaotive). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.