Intubation ComplicationNCT04277078
Predicting Intubation of Patients Hospitalised for Acutely Attacked Asthma
An observational study of Intubation Complication and Asthma, run by Hat Yai Medical Education Center at 1 site in Thailand.
Trial summary
Although the asthmatic treatments currently be effective in term of efficacy of inhaled medications and good clinical outcome including symptom controlled and asthma exacerbation number, the large number of worse event still have been reported. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Intubation Complication, Asthma
- How many people
- 509 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2020to 30 May 2020
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population in this study is a the patient who had been admitted with moderate to severe asthmatic attack. The study will be retrospective review with data in medical record between year 2016-2018. The baseline characteristic and factors which has a potential to intubation will be recored.
Who may be able to join
- Patients who had been admitted and diagnosed as asthmatic attack between year 2016-2018.
- Patients who have age > 15 year old.
Who cannot join
- Non
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Factors of Intubation in Hospitalised Patients With Acutely Attacked Asthma
Although the asthmatic treatments currently be effective in term of efficacy of inhaled medications and good clinical outcome including symptom controlled and asthma exacerbation number, the large number of worse event still have been reported. Few cases eventually have been intubated and died even though using optimal medication. In this study, we will search to identify factors that may influence intubation in hospitalised patient with asthmatic attack.
- Conditions
- Intubation Complication, Asthma
- Medical subject headings
- Asthma
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 |
|---|---|---|
| Intubated asthma attack | Patients who had been hospitalised with asthma attack, then intubated during hospitalisation. | |
| Non-Intubated asthma attack | Patients who had been hospitalised with asthma attack without intubation during hospitalisation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number case of intubated patient
Number case of hospitalized asthmatic attack patients during 2-year review.
Measured: Retropectively review 2 years backard between 2017-2018
Secondary outcomes (3)
Number of previous asthma attack before this admission
Number of previous asthma attack with 12 months before this hospitalization.
Measured: 1 year before admission
Blood eosinophil count at admission time
Blood eosinophil may help predict outcome and risk for intubation.
Measured: Retropectively review 2 years backard between 2017-2018
Number patients dead
Number patient dead during hospitalization
Measured: Retropectively review 2 years backard between 2017-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Feb 2020
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hat Yai Medical Education Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongwit Nakwan, Hat Yai Medical Education Center
- Investigators
- Narongwit Nakwan, M.D., Principal investigator, HatYai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277078
- Sponsor's protocol ID
- 65/2562
- Status last verified
- Feb 2020
- First submitted
- 15 Feb 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Factors of Intubation in Hospitalised Patients With Acutely Attacked Asthma
- ClinicalTrials.gov ID
- NCT04277078
- Acronym / sponsor ID
- 65/2562
- Conditions
- Intubation Complication, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Hat Yai Medical Education CenterUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 20 Feb 2020 (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.
Although the asthmatic treatments currently be effective in term of efficacy of inhaled medications and good clinical outcome including symptom controlled and asthma exacerbation number, the large number of worse event still have been reported. Few cases eventually have been intubated and died even though using optimal medication. In this study, we will search to identify factors that may influence intubation in hospitalised patient with asthmatic attack.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubated asthma attack | – | –Patients who had been hospitalised with asthma attack, then intubated during hospitalisation. |
| Non-Intubated asthma attack | – | –Patients who had been hospitalised with asthma attack without intubation during hospitalisation. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population in this study is a the patient who had been admitted with moderate to severe asthmatic attack. The study will be retrospective review with data in medical record between year 2016-2018. The baseline characteristic and factors which has a potential to intubation will be recored.
Key inclusion criteria (2 listed)
- Patients who had been admitted and diagnosed as asthmatic attack between year 2016-2018.
- Patients who have age > 15 year old.
Key exclusion criteria (1 listed)
- Non
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
Number case of intubated patient
Time frame: Retropectively review 2 years backard between 2017-2018
Number case of hospitalized asthmatic attack patients during 2-year review.
3 secondary outcomes
Number of previous asthma attack before this admission
Time frame: 1 year before admission
Blood eosinophil count at admission time
Time frame: Retropectively review 2 years backard between 2017-2018
Number patients dead
Time frame: Retropectively review 2 years backard between 2017-2018
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 30 Jun 2020.
- Individual participant dataSharing planned: No
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
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Intubation Skill, Intubation Complications
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.
Narongwit Nakwan, M.D. principal investigator
HatYai Hospital
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 Intubation Complication and Asthma, run by Hat Yai Medical Education Center at 1 site in Thailand.
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 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: finished, as of the sponsor's last update on 30 Jun 2020. 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 Thailand. 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?
Number case of intubated patient (time frame: Retropectively review 2 years backard between 2017-2018). 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 30 Jun 2020.