Pulmonary AtelectasisNCT02739854
Prevalence of Atelectasis in Critical Trauma Patients
An observational study of Pulmonary Atelectasis, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to identify the prevalence rate and risk factors for pulmonary complications in patients with critical trauma who intubated and mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Atelectasis
- How many people
- 338 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2016to May 2017
- How long will I take part?
- 1 Year
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The critically traumatic patients who were admitted to the traumatic surgical intensive care unit at Khon Kaen Hospital (February 2016 to February 2017).
Who may be able to join
- An inclusion criterion is the traumatic patients (e.g. head injury, blunt chest, blunt abdomen, and fracture of spine; with or without operative, pure or multitrauma) with intubation and mechanical ventilation who admit at this time period will recruit to the study.
Who cannot join
- a patients who admit less than 1 day will be excluded such as sudden death or moving to other ward because of improving conditions, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence and Risk Factors for Lung Atelectasis in Patients With Critical Trauma Who Are Intubated and Mechanically Ventilated
The purpose of this study is to identify the prevalence rate and risk factors for pulmonary complications in patients with critical trauma who intubated and mechanical ventilation.
- Conditions
- Pulmonary Atelectasis
- Keywords
- trauma, atelectasis
- Medical subject headings
- Pulmonary Atelectasis, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with pulmonary atelectasis
Measured: from the date of randomization until the date of first documented of atelectasis, assessed up to 1 years
Secondary outcomes (4)
number of participants with pneumonia
Measured: from the date of randomization until the date of first documented of pneumonia, assessed up to 1 years
number of participants with pleural effusion
Measured: from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
number of participants with abnormal laboratory values
the laboratory test include arterial blood gases (ABG), Clinical chemistry test (i.e. Blood urea nitrogen, Creatinine, Sodium, Potassium, Phosphorus, Chloride, Magnesium).
Measured: from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
number of participants with adverse events that are related to treatment
These data are collected from medical records (i.e. arrhythmia, hypoxia)
Measured: from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies 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
- Prospective
- Enrolment
- 338 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guntaragorn Hongrattana, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739854
- Sponsor's protocol ID
- VHI-prevalence-atelectasis
- Status last verified
- Jun 2017
- First submitted
- 28 Jan 2016
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Risk Factors for Lung Atelectasis in Patients With Critical Trauma Who Are Intubated and Mechanically Ventilated
- ClinicalTrials.gov ID
- NCT02739854
- Acronym / sponsor ID
- VHI-prevalence-atelectasis
- Conditions
- Pulmonary Atelectasis
- Keywords
- trauma, atelectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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 purpose of this study is to identify the prevalence rate and risk factors for pulmonary complications in patients with critical trauma who intubated and mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The critically traumatic patients who were admitted to the traumatic surgical intensive care unit at Khon Kaen Hospital (February 2016 to February 2017).
Key inclusion criteria (1 listed)
- An inclusion criterion is the traumatic patients (e.g. head injury, blunt chest, blunt abdomen, and fracture of spine; with or without operative, pure or multitrauma) with intubation and mechanical ventilation who admit at this time period will recruit to the study.
Key exclusion criteria (1 listed)
- a patients who admit less than 1 day will be excluded such as sudden death or moving to other ward because of improving conditions, etc.
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 of participants with pulmonary atelectasis
Time frame: from the date of randomization until the date of first documented of atelectasis, assessed up to 1 years
4 secondary outcomes
number of participants with pneumonia
Time frame: from the date of randomization until the date of first documented of pneumonia, assessed up to 1 years
number of participants with pleural effusion
Time frame: from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
number of participants with abnormal laboratory values
Time frame: from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
number of participants with adverse events that are related to treatment
Time frame: from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
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 5 Jun 2017.
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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 Pulmonary Atelectasis, run by Khon Kaen University 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 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: finished, as of the sponsor's last update on 5 Jun 2017. 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 of participants with pulmonary atelectasis (time frame: from the date of randomization until the date of first documented of atelectasis, assessed up to 1 years). 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 5 Jun 2017.