LaryngoscopesNCT04185675
Comparison of Two Types of Videolaryngoscope and Direct Laryngoscope in Expected Non-difficult Airway Patients
A study testing The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions. in people with Laryngoscopes, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Macintosh direct laryngoscope has been mostly widely used for anesthesiologists in operation rooms or emergency situations all over the world. With rapidly development of technical devices, nowadays videolaryngoscope has become more and more popular in hospitals, for it could improve first intubation success rate and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laryngoscopes
- What is being tested?
- The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between18 and 65 years
- ASA(American Society of anesthesiologists) I-II
- BMI 18-30 kg/m2
- scheduled to receive elective surgery under general anesthesia with expected non-difficult airway in operation rooms.
Who cannot join
- expected difficult airway
- allergy to anesthesia induction drugs
- scheduled to receive surgeries affecting vocalisation
- with high reflux aspiration risk
- with acute and chronic cardiac or respiratory failure
- with glucocorticoids medication history
- with mental disorder or transferred to SICU(Surgical Intensive Care Unit) or ICU after surgery who can not cooperate well with others
- refused or have participated in other clinical trials that may have effects on the outcomes of this study
Trial locations and contacts
No sites are listed yet.
About this study
Macintosh direct laryngoscope has been mostly widely used for anesthesiologists in operation rooms or emergency situations all over the world. With rapidly development of technical devices, nowadays videolaryngoscope has become more and more popular in hospitals, for it could improve first intubation success rate and it is easier for beginners to learn. And there are many different types of videolaryngoscope for different purpose, like with or without a channel, different curvature, and so go. In this study, our aim is to study whether the videolaryngoscope which can be adjustable or not costs less intubation time and causes fewer injury in expected non-difficult airway patients by experienced anesthesiologists, compared with the classic Macintosh direct laryngoscope.
- Conditions
- Laryngoscopes
- Being tested
- The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.
- Keywords
- Visual laryngoscope, Direct laryngoscope, Tracheal intubation time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.Device
All the patients will receive the same anesthesia induction, and are randomized to three groups to receive different types of laryngoscope for intubation. These are the direct Macintosh laryngoscope, adjustable videolaryngoscope and nonadjustable videolaryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Not described Receives: Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions. |
| nonadjustable videolaryngoscope | Experimental | Not described Receives: Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions. |
| adjustable videolaryngoscope | Experimental | Not described Receives: Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal intubation time
total time to successful orotracheal intubation
Measured: time from the removal of the patient's face mask for preoxygenation to confirmation of good tube position based on continuous positive end-tidal carbon dioxide reading (at least three breaths without a significant visual decrease in capnography).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngoscopesStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanqing Jin, Doctor, Study chair, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185675
- Sponsor's protocol ID
- E2019012
- Status last verified
- Dec 2019
- First submitted
- 30 Nov 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Types of Videolaryngoscope and Direct Laryngoscope in Expected Non-difficult Airway Patients
- ClinicalTrials.gov ID
- NCT04185675
- Acronym / sponsor ID
- E2019012
- Conditions
- Laryngoscopes
- Keywords
- Visual laryngoscope, Direct laryngoscope, Tracheal intubation time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 4 Dec 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.
Macintosh direct laryngoscope has been mostly widely used for anesthesiologists in operation rooms or emergency situations all over the world. With rapidly development of technical devices, nowadays videolaryngoscope has become more and more popular in hospitals, for it could improve first intubation success rate and it is easier for beginners to learn. And there are many different types of videolaryngoscope for different purpose, like with or without a channel, different curvature, and so go. In this study, our aim is to study whether the videolaryngoscope which can be adjustable or not costs less intubation time and causes fewer injury in expected non-difficult airway patients by experienced anesthesiologists, compared with the classic Macintosh direct laryngoscope.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions. |
| nonadjustable videolaryngoscope | Experimental | Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions. |
| adjustable videolaryngoscope | Experimental | Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between18 and 65 years
- ASA(American Society of anesthesiologists) I-II
- BMI 18-30 kg/m2
- scheduled to receive elective surgery under general anesthesia with expected non-difficult airway in operation rooms.
Key exclusion criteria (8 listed)
- expected difficult airway
- allergy to anesthesia induction drugs
- scheduled to receive surgeries affecting vocalisation
- with high reflux aspiration risk
- with acute and chronic cardiac or respiratory failure
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 |
|---|---|---|
| The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.All the patients will receive the same anesthesia induction, and are randomized to three groups to receive different types of laryngoscope for intubation. These are the direct Macintosh laryngoscope, adjustable videolaryngoscope and nonadjustable videolaryngoscope. | Device | Macintosh laryngoscope, adjustable videolaryngoscope, nonadjustable videolaryngoscope |
Primary outcome
Tracheal intubation time
Time frame: time from the removal of the patient's face mask for preoxygenation to confirmation of good tube position based on continuous positive end-tidal carbon dioxide reading (at least three breaths without a significant visual decrease in capnography).
total time to successful orotracheal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: Yes
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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.
Sanqing Jin, Doctor study chair
Sixth Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions. in people with Laryngoscopes, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 4 inclusion and 8 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 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yanna Pi, Master (86 18819186153, piyanna@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracheal intubation time (time frame: time from the removal of the patient's face mask for preoxygenation to confirmation of good tube position based on continuous positive end-tidal carbon dioxide reading (at least three breaths without a significant visual decrease in capnography).). 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 11 Dec 2019.