Nasal IntubationNCT04038762
Inflation-deflation Method for Nasal Intubation in Pediatric Patients
A study testing cuff deflation-inflation -deflation method in people with Nasal Intubation, run by Suez Canal University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Nasal Intubation
- What is being tested?
- cuff deflation-inflation -deflation method
- 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
- 1 Jun 2019to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II,
- 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.
Egypt1 site, 1 recruiting
- Recruiting
Tarek F.Tammam
Cairo, 12311
Tarek F. Tammam, Professor, 00201280871947, tarek1367@hotmail.com
Ghada A. Kamhawy, Lecturer, 00201224737320, gkamhawy@yahoo.com
About this study
Official title: Tracheal Tube Cuff Inflation-deflation Method for Video Laryngoscope-assisted Nasal Intubation in Pediatric Patients
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.
Read the 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
- Being tested
- cuff deflation-inflation -deflation method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cuff deflation-inflation -deflation methodProcedure or surgery
Also called pre-cuff inflation
Nasotracheal intubation placed with video-laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps
| Study group | Role | What they receive |
|---|---|---|
| Conventional nasal intubation | Active comparator | 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 Receives: Procedure: cuff deflation-inflation -deflation method |
| Nasotracheal Intubation with cuff inflation-deflation method | Experimental | Nasotracheal intubation placed with video laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps Receives: Procedure: cuff deflation-inflation -deflation method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. T
The percentage of patients who did not require Magill forceps for nasal intubation success was recorded.
Measured: during nasal intubation : 60 seconds
Secondary outcomes (6)
The time period for the second phase nasal intubation
The time in seconds for the second phase nasal intubation
Measured: 60 seconds
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: 120 seconds
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: 15 seconds
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: Intraoperative and in the first 48 postoperative hours]
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 complete recovery of patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Jun 2019
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal IntubationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek F.Tammam, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038762
- Sponsor's protocol ID
- Tammam
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- 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 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Tube Cuff Inflation-deflation Method for Video Laryngoscope-assisted Nasal Intubation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04038762
- Acronym / sponsor ID
- Tammam
- Conditions
- Nasal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 31 Jul 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional nasal intubation | Active comparator | Procedure: cuff deflation-inflation -deflation methodPassage of an endotracheal tube via the nare followed by video laryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps |
| Nasotracheal Intubation with cuff inflation-deflation method | Experimental | Procedure: cuff deflation-inflation -deflation methodNasotracheal intubation placed with video laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-II,
- 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 |
|---|---|---|
| cuff deflation-inflation -deflation methodAlso: pre-cuff inflationNasotracheal intubation placed with video-laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps | Procedure or surgery | Conventional nasal intubation, Nasotracheal Intubation with cuff inflation-deflation method |
Primary outcome
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. T
Time frame: during nasal intubation : 60 seconds
The percentage of patients who did not require Magill forceps for nasal intubation success was recorded.
6 secondary outcomes
The time period for the second phase nasal intubation
Time frame: 60 seconds
The number of attempts required for successful nasal intubation.
Time frame: 120 seconds
Amount of injected air for cuff inflation
Time frame: 15 seconds
Assessment of side effects of using Magill forceps during nasal intubation
Time frame: Intraoperative and in the first 48 postoperative hours]
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 complete recovery of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cuff deflation-inflation -deflation method in people with 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: status not confirmed, as of the sponsor's last update on 31 Jul 2019. 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?
Results are not available in the source record.
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?
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. T (time frame: during nasal intubation : 60 seconds). 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 Jul 2019.