Techniques of Endotracheal Intubation in PediatricsNCT03778762
Re-evaluation of Blind Intubation Through the Air-Q Intubating Laryngeal Airway
A study testing Blind tracheal intubation through AirQ and Fiberscopic tracheal intubation through AirQ in people with Techniques of Endotracheal Intubation in Pediatrics, run by Mansoura University at 1 site in Egypt.
Trial summary
To compare the success rate of blind technique with correction manoeuvres versus fiber optic- guided Intubation through the air Q laryngeal airway in pediatric patients Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Techniques of Endotracheal Intubation in Pediatrics
- What is being tested?
- Blind tracheal intubation through AirQ and Fiberscopic tracheal intubation through AirQ
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 30 Sep 2018
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists physical status I-II
- Body weight from 4 to 30 kg
Who cannot join
- Obesity
- History of gastroesophageal reflux
- History of hyperactive airway
- Patients with congenital disorders associated with difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blind Tracheal Intubation Through the Air-Q Intubating Laryngeal Airway in Pediatric Patients. Re-evaluation. A Randomized Controlled Trial.
To compare the success rate of blind technique with correction manoeuvres versus fiber optic- guided Intubation through the air Q laryngeal airway in pediatric patients
Read the detailed description
A prior G-power analysis was done to estimate the sample size. The primary outcome of this study was the first trial success rate. Using fibre exact test and assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 58 patients per group would be sufficient to detect a difference 10 % in success rate among the groups. A drop out 10% of cases was expected; therefore 63 patients were required in each group to detect the difference.
- Being tested
- Blind tracheal intubation through AirQ, Fiberscopic tracheal intubation through AirQ
- Keywords
- air-Q, blind intubation, correction maneuvers, fiberoptic guided intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blind tracheal intubation through AirQProcedure or surgery
underwent blind intubation with correction manoeuvres
Fiberscopic tracheal intubation through AirQProcedure or surgery
: underwent fibreoptic guided intubation
| Study group | Role | What they receive |
|---|---|---|
| Blind tracheal intubation through AirQ | Active comparator | Patients were intubated through the air-Q blindly Receives: Procedure: Blind tracheal intubation through AirQ |
| Fiberscopic tracheal intubation through AirQ | Placebo comparator | Patients were intubated through the air-Q using fibreoptic bronchoscope Receives: Procedure: Fiberscopic tracheal intubation through AirQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first trial success rate
percentage of cases of successful tracheal intubation during the first trial
Measured: during first trial of intubation procedure
Secondary outcomes (8)
The total success rate
percentage of cases underwent successful tracheal intubation during either first or second trial
Measured: from beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedure
Time to ventilation
time needed to get full capno-graphic waves through connection of air Q to breathing circuit
Measured: procedure (Time from beginning of air-Q insertion till full capno-graphic wave)
Time to intubation
time needed to get full capno-graphic waves through connection of endotracheal tube to breathing circuit
Measured: procedure (Time from beginning of manipulation of the ETT till full capno-graphic wave)
Heart rate
Measured: After induction of anesthesia till 10 minutes after intubation
Mean arterial blood pressure
Measured: After induction of anesthesia till 10 minutes after intubation
blood staining of the device
Measured: from extubation till 24 hours after extubation
post-intubation croup
Measured: from extubation till 24 hours after extubation
hoarsenes
and its grade if present Grades of hoarseness: 1=non, 2= mild, 3= moderate, 4= severe)
Measured: from extubation till 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Dec 2017
- Primary completion1 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Techniques of Endotracheal Intubation in PediatricsStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enas A Abd el Motlb, MD, Study chair, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778762
- Sponsor's protocol ID
- R/17.11.129
- Status last verified
- Dec 2018
- First submitted
- 16 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blind Tracheal Intubation Through the Air-Q Intubating Laryngeal Airway in Pediatric Patients. Re-evaluation. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03778762
- Acronym / sponsor ID
- R/17.11.129
- Keywords
- air-Q, blind intubation, correction maneuvers, fiberoptic guided intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 Dec 2018 (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.
To compare the success rate of blind technique with correction manoeuvres versus fiber optic- guided Intubation through the air Q laryngeal airway in pediatric patients
Detailed description
A prior G-power analysis was done to estimate the sample size. The primary outcome of this study was the first trial success rate. Using fibre exact test and assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 58 patients per group would be sufficient to detect a difference 10 % in success rate among the groups. A drop out 10% of cases was expected; therefore 63 patients were required in each group to detect the difference.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blind tracheal intubation through AirQ | Active comparator | Procedure: Blind tracheal intubation through AirQPatients were intubated through the air-Q blindly |
| Fiberscopic tracheal intubation through AirQ | Placebo comparator | Procedure: Fiberscopic tracheal intubation through AirQPatients were intubated through the air-Q using fibreoptic bronchoscope |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I-II
- Body weight from 4 to 30 kg
Key exclusion criteria (4 listed)
- Obesity
- History of gastroesophageal reflux
- History of hyperactive airway
- Patients with congenital disorders associated with difficult airway
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 |
|---|---|---|
| Blind tracheal intubation through AirQunderwent blind intubation with correction manoeuvres | Procedure or surgery | Blind tracheal intubation through AirQ |
| Fiberscopic tracheal intubation through AirQ: underwent fibreoptic guided intubation | Procedure or surgery | Fiberscopic tracheal intubation through AirQ |
Primary outcome
The first trial success rate
Time frame: during first trial of intubation procedure
percentage of cases of successful tracheal intubation during the first trial
8 secondary outcomes
The total success rate
Time frame: from beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedure
Time to ventilation
Time frame: procedure (Time from beginning of air-Q insertion till full capno-graphic wave)
Time to intubation
Time frame: procedure (Time from beginning of manipulation of the ETT till full capno-graphic wave)
Heart rate
Time frame: After induction of anesthesia till 10 minutes after intubation
Mean arterial blood pressure
Time frame: After induction of anesthesia till 10 minutes after intubation
blood staining of the device
Time frame: from extubation till 24 hours after extubation
post-intubation croup
Time frame: from extubation till 24 hours after extubation
hoarsenes
Time frame: from extubation till 24 hours after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: Undecided
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.
Enas A Abd el Motlb, MD study chair
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blind tracheal intubation through AirQ and Fiberscopic tracheal intubation through AirQ in people with Techniques of Endotracheal Intubation in Pediatrics, run by Mansoura 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: finished, as of the sponsor's last update on 19 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first trial success rate (time frame: during first trial of intubation procedure). 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 19 Dec 2018.