Prevalence of Atelectasis in Critical Trauma Patients | NCT02739854

Studies
Prevalence of Atelectasis in Critical Trauma Patients

NCT02739854

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

Jun 5, 2017Actual

Enrollment

338Actual

Phase

Not provided

Conditions

Pulmonary Atelectasis

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 28, 2016

First Submission Date that Met QC Criteria

Apr 11, 2016

First Posted Date

Apr 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2017

Last Update Posted Date

Jun 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

338Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

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).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Khon Kaen University		Khon Kaen		40002	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided