Airway Complication of AnesthesiaNCT03592758
Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes
An observational study of Airway Complication of Anesthesia, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
evaluate the efficacy of the ultrasound approach in predicting difficult mask ventilation in a heterogeneous population of patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Complication of Anesthesia
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 14 Jun 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patient > 18 ys undergoing general anesthesia for elective surgery
Who may be able to join
- all patient > 18years old undergoing general anesthesia for elective surgery
Who cannot join
- Patients with fractures of the bones of the facial mass;
- Patients with laryngeal tumors
- Patients previously undergoing demolition of the larynx or neck;
- Tracheostomized patients;
- Pregnancy;
- Inter-incisive distance <3 cm;
Show all 9Show fewer
- severely limited cervical mobility;
- Patients who are not given muscle relaxants
- Patient rejection.
Trial locations and contacts
1 site in 1 country.
About this study
evaluate the efficacy of the ultrasound approach in predicting difficult mask ventilation in a heterogeneous population of patients undergoing general anesthesia.
Read the detailed description
Preoperative ultrasound of the upper airway and detection of 5 ultrasound measurements:
Trachea-skin distance at the level of the thyroid isthmus; Trachea-skin distance at the jugular level Front commissure-skin distance; Distance from skin to the thyroid membrane Distance between hyoid bone and skin. Comparison of this measurement with HAN-scale for prediction of difficult mask ventilation during general anesthesia
- Conditions
- Airway Complication of Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound assessment | all patient are evaluated by an ultrasound assessment before general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound assessment
the association between the ultrasound measurement and the difficulty of mask ventilation measured with the "Han scale". "Han scale" classify mask-ventilation in five grade of progressive difficulty: 0) mask ventilation did not attempt, 1) easy 2) difficult and requiring oral airway 3) very difficult requiring two practitioners 4) unable to mask ventilate.
"Han scale" is the only grading scale available used routinely in anesthesiologic assessment of bag-mask ventilation.
Measured: Ultrasound assessment will be performed 30 minutes before induction of general anaesthesia and the mask ventilation evaluation will be performed 3 minutes after induction with ''Han scale".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Jun 2017
- Primary completion10 Jun 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Alessandri, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592758
- Sponsor's protocol ID
- UEDAM
- Status last verified
- Jul 2018
- First submitted
- 19 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
PubMed 31742568
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes
- ClinicalTrials.gov ID
- NCT03592758
- Acronym / sponsor ID
- UEDAM
- Conditions
- Airway Complication of Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 19 Jul 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.
evaluate the efficacy of the ultrasound approach in predicting difficult mask ventilation in a heterogeneous population of patients undergoing general anesthesia.
Detailed description
Preoperative ultrasound of the upper airway and detection of 5 ultrasound measurements:
Trachea-skin distance at the level of the thyroid isthmus; Trachea-skin distance at the jugular level Front commissure-skin distance; Distance from skin to the thyroid membrane Distance between hyoid bone and skin. Comparison of this measurement with HAN-scale for prediction of difficult mask ventilation during general anesthesia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound assessment | – | –all patient are evaluated by an ultrasound assessment before general anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patient > 18 ys undergoing general anesthesia for elective surgery
Key inclusion criteria (1 listed)
- all patient > 18years old undergoing general anesthesia for elective surgery
Key exclusion criteria (9 listed)
- Patients with fractures of the bones of the facial mass;
- Patients with laryngeal tumors
- Patients previously undergoing demolition of the larynx or neck;
- Tracheostomized patients;
- Pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ultrasound assessment
Time frame: Ultrasound assessment will be performed 30 minutes before induction of general anaesthesia and the mask ventilation evaluation will be performed 3 minutes after induction with ''Han scale".
the association between the ultrasound measurement and the difficulty of mask ventilation measured with the "Han scale". "Han scale" classify mask-ventilation in five grade of progressive difficulty: 0) mask ventilation did not attempt, 1) easy 2) difficult and requiring oral airway 3) very difficult requiring two practitioners 4) unable to mask ventilate. "Han scale" is the only grading scale available used routinely in anesthesiologic assessment of bag-mask ventilation.
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 Jul 2018.
- Derived from this study: PubMed 31742568Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia, run by University of Roma La Sapienza at 1 site in Italy.
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 9 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 Jul 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 Italy. 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?
ultrasound assessment (time frame: Ultrasound assessment will be performed 30 minutes before induction of general anaesthesia and the mask ventilation evaluation will be performed 3 minutes after induction with ''Han scale".). 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 NCT03592758, which also lists 1 linked publication.
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 Jul 2018.