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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02739854
Other study ID # VHI-prevalence-atelectasis
Secondary ID
Status Completed
Phase N/A
First received January 28, 2016
Last updated June 2, 2017
Start date April 2016
Est. completion date May 2017

Study information

Verified date June 2017
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 338
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Khon Kaen University Khon Kaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of participants with pulmonary atelectasis from the date of randomization until the date of first documented of atelectasis, assessed up to 1 years
Secondary number of participants with pneumonia from the date of randomization until the date of first documented of pneumonia, assessed up to 1 years
Secondary number of participants with pleural effusion from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
Secondary 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). from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
Secondary number of participants with adverse events that are related to treatment These data are collected from medical records (i.e. arrhythmia, hypoxia) from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years
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