Intubation;Difficultmod mallampatiNCT03443947
Modified Mallampati Scoring Technique for Airway Assessment
A study testing Tongue depressor group in people with Intubation;Difficult, run by AlRefaey Kandeel at 2 sites in Egypt.
Trial summary
comparing a new technique for airway assessment using tongue depressor versus conventional mallampati scoring system. Using tongue depressor to improve airway score is suggested to increase reliability of airway assessment model Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Tongue depressor group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2018to 31 Dec 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients scheduled for elective surgery
Who cannot join
- known difficult airway trismus cases maxillofacial anomalies
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Gastroenterology center
Al Mansurah, 35516
Amr M Yassen, professor, amryassen@hotmail.com
Mansoura university
Al Manşūrah, Dkahleya
About this study
comparing a new technique for airway assessment using tongue depressor versus conventional mallampati scoring system. Using tongue depressor to improve airway score is suggested to increase reliability of airway assessment model
- Conditions
- Intubation;Difficult
- Being tested
- Tongue depressor group, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue depressor groupDevice
using a tongue depressor to assess airway score without tongue protrusion
control groupProcedure or surgery
airway assessment after tongue protrusion
| Study group | Role | What they receive |
|---|---|---|
| D group | Experimental | Not described Receives: Device: Tongue depressor group; Procedure: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of airway difficulty
correlation between airway score and view during laryngoscopy
Measured: before intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlRefaey Kandeel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443947
- Sponsor's protocol ID
- Dr Waleed 1
- Acronym
- mod mallampati
- Status last verified
- Feb 2018
- First submitted
- 3 Jan 2018
- Last updated
- 23 Feb 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 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Mallampati Scoring Technique for Airway Assessment
- ClinicalTrials.gov ID
- NCT03443947
- Acronym / sponsor ID
- mod mallampati / Dr Waleed 1
- Conditions
- Intubation;Difficult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AlRefaey KandeelUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 23 Feb 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.
comparing a new technique for airway assessment using tongue depressor versus conventional mallampati scoring system. Using tongue depressor to improve airway score is suggested to increase reliability of airway assessment model
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D group | Experimental | Device: Tongue depressor group, Procedure: control group |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients scheduled for elective surgery
Key exclusion criteria (1 listed)
- known difficult airway trismus cases maxillofacial anomalies
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 |
|---|---|---|
| Tongue depressor groupusing a tongue depressor to assess airway score without tongue protrusion | Device | D group |
| control groupairway assessment after tongue protrusion | Procedure or surgery | D group |
Primary outcome
assessment of airway difficulty
Time frame: before intubation
correlation between airway score and view during laryngoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue depressor group in people with Intubation;Difficult, run by AlRefaey Kandeel at 2 sites 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 1 inclusion and 1 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
assessment of airway difficulty (time frame: before intubation). 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 Feb 2018.