Endotracheal IntubationNCT04483895
Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates
A study testing Endotracheal tube insertion in people with Endotracheal Intubation, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated according to the 7-8-9 method. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Endotracheal tube insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2019to 21 Dec 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Full term and preterm neonates who were admitted to NICU and needing endotracheal intubation for invasive mechanical ventilation or administration of surfactant.
- Delivery room intubations were not included as infants are not routinely weighed prior to resuscitation at our hospital. However, infants intubated in the delivery room who were subsequently intubated in the NICU were eligible for inclusion in our study.
Who cannot join
- 1. Major upper or lower airway anomalies. 2. Infants with craniofacial, vertebral anomalies. 3. Significant congenital anomalies including cardiac, abdominal or respiratory.
- 4. Neonates those whose parents declined consent were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
medicine -Ain Shams University
Cairo
Dina Mohamed, M.D., +1112636097, drdodi28@gmail.com
Dina Shinkar, M.D.
About this study
This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated according to the 7-8-9 method.
- Conditions
- Endotracheal Intubation
- Being tested
- Endotracheal tube insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tube insertionProcedure or surgery
ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method
| Study group | Role | What they receive |
|---|---|---|
| The OHL method | Active comparator | the ETT insertion depth was estimated according to the OHL method. Receives: Procedure: Endotracheal tube insertion |
| The 7-8-9 method | Active comparator | the ETT insertion depth was estimated according to the 7-8-9 method. Receives: Procedure: Endotracheal tube insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.
Measured: 28 days
Secondary outcomes (1)
the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start15 Nov 2019
- Primary completion21 Dec 2020 (estimated)
- Study completion21 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Mohamed Shinkar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483895
- Sponsor's protocol ID
- Maha Abdel-Raouf master thesis
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- 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 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates
- ClinicalTrials.gov ID
- NCT04483895
- Acronym / sponsor ID
- Maha Abdel-Raouf master thesis
- Conditions
- Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 21 Dec 2020 (estimated)
- Study completion
- 21 Dec 2020 (estimated)
- First posted
- 23 Jul 2020 (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.
This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated according to the 7-8-9 method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The OHL method | Active comparator | Procedure: Endotracheal tube insertionthe ETT insertion depth was estimated according to the OHL method. |
| The 7-8-9 method | Active comparator | Procedure: Endotracheal tube insertionthe ETT insertion depth was estimated according to the 7-8-9 method. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- • Full term and preterm neonates who were admitted to NICU and needing endotracheal intubation for invasive mechanical ventilation or administration of surfactant.
Key exclusion criteria (2 listed)
- 1. Major upper or lower airway anomalies. 2. Infants with craniofacial, vertebral anomalies. 3. Significant congenital anomalies including cardiac, abdominal or respiratory.
- 4. Neonates those whose parents declined consent were 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 |
|---|---|---|
| Endotracheal tube insertionETT was inserted and the depth was estimated by either OHL method or 7-8-9 method | Procedure or surgery | The 7-8-9 method, The OHL method |
Primary outcome
the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.
Time frame: 28 days
1 secondary outcome
the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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 Endotracheal tube insertion in people with Endotracheal Intubation, run by Ain Shams 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 2 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 23 Jul 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of ETTs in abnormal position for each of both insertion depth prediction methods. (time frame: 28 days). 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 23 Jul 2020.