Difficult IntubationNCT03999476
Evaluation of the Efficacy of Ambu® aScope for Intubation in Cancer Tongue
A study testing ambu ascope and fibreroptic bronchoscope in people with Difficult Intubation, run by mahmoud salem soliman at 1 site in Egypt.
Trial summary
This study compares the ascope with standard fiberscope using the nasal route of intubation in patient having sever difficult airway (having posterior one third cancer tongue with fixed mobility) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- ambu ascope and fibreroptic bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 19 May 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of ASA physical status I and II who will be scheduled for posterior third fixed cancer tongue with severe difficult airway requiring naso-tracheal intubation
- aged 18-70 years
Who cannot join
- ASA 2 or 4
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized- Single Blind Trial of Ambu Ascope and Fiberoptic in Severely Difficult Air Way Patient Having Posterior Third Fixed Tongue Cancer
This study compares the ascope with standard fiberscope using the nasal route of intubation in patient having sever difficult airway (having posterior one third cancer tongue with fixed mobility)
Read the detailed description
patient will be allocated into two group according to the type of endoscope used group (F) fibro scope group and group (A) the ambu ascope group The timer will be started (T0), when touching the fiberscope or a scope. The standard fiberscope or a scope2 will be introduced through the nostril and advanced through the vocal cords, once carina identified the time will be recorded ( T1) When correct positioning of the trachea confirmed by detection of the end-tidal co2 curve on capnography (T2).
- Conditions
- Difficult Intubation
- Being tested
- ambu ascope, fibreroptic bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ambu ascopeDevice
Also called Ambu® aScope™
nasal route intubation by the device in fixed cancer tongue patients
fibreroptic bronchoscopeDevice
nasal route intubation by the device in fixed cancer tongue patients
| Study group | Role | What they receive |
|---|---|---|
| ambu scope | Experimental | intubation of cancer tongue patients with ambu scope device Receives: Device: ambu ascope |
| fiberoptic | Active comparator | intubation of cancer tongue patients with fiberoptic device Receives: Device: fibreroptic bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of successful intubation
measuring time in seconds for reaching carina and time for successful intubation
.
Measured: 5 minutes
Secondary outcomes (4)
quality of vision
subjective assessment by operator
Measured: 5 minutes
incidence of complications
accounting number of desaturation , bleeding , hypoxia .
Measured: 15 minutes
easiness of intubation
subjective assessment
Measured: 5 minutes
number of intubation trials
counting number of intubation in each group
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Aug 2018
- Primary completion5 May 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Difficult 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- mahmoud salem soliman
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, mahmoud salem soliman, Cairo University
- Investigators
- Ekramy M Abdelghafar, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999476
- Sponsor's protocol ID
- intubation in cancer tongue
- Status last verified
- Oct 2022
- First submitted
- 22 Jun 2019
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data for primary and secondary outcome measures will be made available
Publications
Reeves DS, Brown NM. Mycobacterial contamination of fibreoptic bronchoscopes. J Hosp Infect. 1995 Jun;30 Suppl:531-6. doi: 10.1016/0195-6701(95)90059-4.
PubMed 7560994Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33.
PubMed 15845720Marfin AG, Iqbal R, Mihm F, Popat MT, Scott SH, Pandit JJ. Determination of the site of tracheal tube impingement during nasotracheal fibreoptic intubation. Anaesthesia. 2006 Jul;61(7):646-50. doi: 10.1111/j.1365-2044.2006.04652.x.
PubMed 16792609
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized- Single Blind Trial of Ambu Ascope and Fiberoptic in Severely Difficult Air Way Patient Having Posterior Third Fixed Tongue Cancer
- ClinicalTrials.gov ID
- NCT03999476
- Acronym / sponsor ID
- intubation in cancer tongue
- Conditions
- Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- mahmoud salem solimanUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 26 Jun 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.
This study compares the ascope with standard fiberscope using the nasal route of intubation in patient having sever difficult airway (having posterior one third cancer tongue with fixed mobility)
Detailed description
patient will be allocated into two group according to the type of endoscope used group (F) fibro scope group and group (A) the ambu ascope group The timer will be started (T0), when touching the fiberscope or a scope. The standard fiberscope or a scope2 will be introduced through the nostril and advanced through the vocal cords, once carina identified the time will be recorded ( T1) When correct positioning of the trachea confirmed by detection of the end-tidal co2 curve on capnography (T2).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| ambu scope | Experimental | Device: ambu ascopeintubation of cancer tongue patients with ambu scope device |
| fiberoptic | Active comparator | Device: fibreroptic bronchoscopeintubation of cancer tongue patients with fiberoptic device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients of ASA physical status I and II who will be scheduled for posterior third fixed cancer tongue with severe difficult airway requiring naso-tracheal intubation
- aged 18-70 years
Key exclusion criteria (2 listed)
- ASA 2 or 4
- pregnant
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 |
|---|---|---|
| ambu ascopeAlso: Ambu® aScope™nasal route intubation by the device in fixed cancer tongue patients | Device | ambu scope |
| fibreroptic bronchoscopenasal route intubation by the device in fixed cancer tongue patients | Device | fiberoptic |
Primary outcome
time of successful intubation
Time frame: 5 minutes
measuring time in seconds for reaching carina and time for successful intubation .
4 secondary outcomes
quality of vision
Time frame: 5 minutes
incidence of complications
Time frame: 15 minutes
easiness of intubation
Time frame: 5 minutes
number of intubation trials
Time frame: 30 minutes
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 10 Oct 2022.
- Background: PubMed 7560994Reeves DS, Brown NM. Mycobacterial contamination of fibreoptic bronchoscopes. J Hosp Infect. 1995 Jun;30 Suppl:531-6. doi: 10.1016/0195-6701(95)90059-4.
- Background: PubMed 15845720Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33.
- Background: PubMed 16792609Marfin AG, Iqbal R, Mihm F, Popat MT, Scott SH, Pandit JJ. Determination of the site of tracheal tube impingement during nasotracheal fibreoptic intubation. Anaesthesia. 2006 Jul;61(7):646-50. doi: 10.1111/j.1365-2044.2006.04652.x.
- Individual participant dataSharing planned: Yes. De-identified participant data for primary and secondary outcome measures will be made available
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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.
Ekramy M Abdelghafar, MD principal investigator
Cairo 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 ambu ascope and fibreroptic bronchoscope in people with Difficult Intubation, run by mahmoud salem soliman 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: finished, as of the sponsor's last update on 10 Oct 2022. 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?
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?
time of successful intubation (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03999476, which also lists 3 linked publications.
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 10 Oct 2022.