Intubation; Difficult or FailedNCT06042829
Impact of Covid-19 Aerosol Box On Intubation Success Rate
A study testing Intubation using aerosol box and Intubation without aerosol box in people with Intubation; Difficult or Failed, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
The safety of novel medical device must be assessed before being implemented into clinical practice. In the case of aerosol box, one of the safety features concerned includes its impact on intubation and how it affect the probability of efficient intubation in order to avoid risk of hypoxia to patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Intubation using aerosol box and Intubation without aerosol box
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Nov 2020to 22 Nov 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- American Society of Anesthesiologist (ASA) I or II patients
- Tested negative for COVID-19 prior to surgery
- Patient scheduled for elective surgery under general anaesthesia
Who cannot join
- Claustrophobia
- Difficult airway features
- Body mass index (BMI) of more than 35 kg/m2
- Body habitus not physically fit into the aerosol box.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Covid-19 Aerosol Box On Intubation Success Rate and Intubation Time
The safety of novel medical device must be assessed before being implemented into clinical practice. In the case of aerosol box, one of the safety features concerned includes its impact on intubation and how it affect the probability of efficient intubation in order to avoid risk of hypoxia to patient. As the barrier box is newly invented, there have been limited studies published.
This study aims to compare intubation success rate between intubation with and without aerosol box in real patients, which will determine the chances of efficient intubation and reflect the safety features of the aerosol box.
Read the detailed description
General Objective To determine whether intubation performed using aerosol box will have a lower chance of success as compared to intubation without using the box.
Specific Objectives
- To determine whether intubation with aerosol box will require more time for successful intubation as compared to intubation without the box.
- To compare the ease of intubation and determine whether intubation using aerosol box will require additional airway manipulation as compared to intubation without using the box.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Intubation using aerosol box, Intubation without aerosol box
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation using aerosol boxDevice
Intubation time and ease of intubation using aerosol box
Intubation without aerosol boxDevice
Intubation time and ease of intubation without aerosol box
| Study group | Role | What they receive |
|---|---|---|
| Intubation with aerosol box | Experimental | Aerosol box group where patient will be intubated using aerosol box Receives: Device: Intubation using aerosol box |
| Intubation without Aerosol box | Active comparator | Without aerosol box group whereby patients will be intubated without aerosol box. Receives: Device: Intubation without aerosol box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal intubation time
Time taken from the laryngoscope blade passes through front incisors, followed by endotracheal intubation being inserted into trachea, and until the first upstroke of the capnograph trace visible as proof of successful tracheal intubation (the measurement is measured in seconds)
Measured: 1 year
Secondary outcomes (1)
Ease of tracheal intubation
Based on scale of tracheal intubation difficulty. The scale is called Intubation Difficulty Scale. Intubation difficulty scale is a numerical score of total intubation difficulty and is based on seven parameters known to be associated with difficult intubation. The seven parameters are number of attempts, number of intubators, number of alternative techniques, Cormack-Lehane laryngoscopy grades, requirement of lifting force of laryngoscopy, application of laryngeal pressure, and mobility of vocal cords. The score will be summed. The degree of difficulty will be categorized into easy (IDS score of 0), slight difficulty (IDS of 1-4) and moderate to major difficulty (IDS of 5 and more) according to the total score. The higher score is associated with a higher prevalence of difficult intubation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start23 Nov 2020
- Primary completion22 Oct 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nurul Najwa Mohd Noor Dr, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042829
- Sponsor's protocol ID
- HTM-2020-006
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Covid-19 Aerosol Box On Intubation Success Rate and Intubation Time
- ClinicalTrials.gov ID
- NCT06042829
- Acronym / sponsor ID
- HTM-2020-006
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 21 Sep 2023 (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.
The safety of novel medical device must be assessed before being implemented into clinical practice. In the case of aerosol box, one of the safety features concerned includes its impact on intubation and how it affect the probability of efficient intubation in order to avoid risk of hypoxia to patient. As the barrier box is newly invented, there have been limited studies published.
This study aims to compare intubation success rate between intubation with and without aerosol box in real patients, which will determine the chances of efficient intubation and reflect the safety features of the aerosol box.
Detailed description
General Objective To determine whether intubation performed using aerosol box will have a lower chance of success as compared to intubation without using the box.
Specific Objectives
- To determine whether intubation with aerosol box will require more time for successful intubation as compared to intubation without the box.
- To compare the ease of intubation and determine whether intubation using aerosol box will require additional airway manipulation as compared to intubation without using the box.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation with aerosol box | Experimental | Device: Intubation using aerosol boxAerosol box group where patient will be intubated using aerosol box |
| Intubation without Aerosol box | Active comparator | Device: Intubation without aerosol boxWithout aerosol box group whereby patients will be intubated without aerosol box. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- American Society of Anesthesiologist (ASA) I or II patients
- Tested negative for COVID-19 prior to surgery
- Patient scheduled for elective surgery under general anaesthesia
Key exclusion criteria (4 listed)
- Claustrophobia
- Difficult airway features
- Body mass index (BMI) of more than 35 kg/m2
- Body habitus not physically fit into the aerosol box.
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 |
|---|---|---|
| Intubation using aerosol boxIntubation time and ease of intubation using aerosol box | Device | Intubation with aerosol box |
| Intubation without aerosol boxIntubation time and ease of intubation without aerosol box | Device | Intubation without Aerosol box |
Primary outcome
Tracheal intubation time
Time frame: 1 year
Time taken from the laryngoscope blade passes through front incisors, followed by endotracheal intubation being inserted into trachea, and until the first upstroke of the capnograph trace visible as proof of successful tracheal intubation (the measurement is measured in seconds)
1 secondary outcome
Ease of tracheal intubation
Time frame: 1 year
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 21 Sep 2023.
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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.
Nurul Najwa Mohd Noor Dr principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation using aerosol box and Intubation without aerosol box in people with Intubation; Difficult or Failed, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 4 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 21 Sep 2023. 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 Malaysia. 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?
Tracheal intubation time (time frame: 1 year). 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 21 Sep 2023.