NCT02739854

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

January 28, 2016

Last Update Submit

June 2, 2017

Conditions

Pulmonary Atelectasis

Keywords

traumaatelectasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • number of participants with pneumonia

    from the date of randomization until the date of first documented of pneumonia, assessed up to 1 years

  • 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

  • number of participants with abnormal laboratory values

    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

    from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Pulmonary AtelectasisWounds and Injuries

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2016

First Posted

April 15, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 5, 2017

Record last verified: 2017-06

Locations

TH(1)