Pulmonary Contusion Flail Chest Complex

March 20, 2017 updated by: Abdelrady S Ibrahim, MD, Assiut University

Impact of Pulmonary Contusion in Patient's Outcome When Associated With Traumatic Flail Chest: An Observational Study

The study included 20 adult patients presented by multiple fractured ribs (flail segment) with thoracic trauma severity score (TTSS) between 5 and 15. All patients received mid-thoracic epidural analgesia with 0.125% Bupivacaine and 1 μg/ml fentanyl. The patients were ventilated using non-invasive positive pressure ventilation (NIPPV). Follow up arterial blood gases, chest X-ray and CT scan were obtained. Parameters to be recorded: Patient's characteristics and clinical data including pulmonary contusion, number of fractured ribs, pleural involvement, PaO2/FiO2 ratio on admission, weaning outcome, duration of NIPPV, length of stay in ICU (LOS ICU), complications and mortality rate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

20 Patients fulfilling the inclusion criteria were submitted to strapping and packing in the form of dressing and fixing with elastoplast. All patients were ventilated using NIPPV (Engstrom Carestation), which was delivered to the patient through full-face mask and was started with pressure support of 8-12 cmH2O and PEEP of 3-5 cmH2O and gradually increased in 2 cmH2O steps. When patients tolerate FiO2 ≤ 0.5 with pressure support ≤ 8 cmH2O and PEEP ≤ 5 cmH2O for > 6 consecutive hours, withdrawal from NIPPV was attempted daily in 30 minutes spontaneous breathing trials. Therapy was considered successful if endotracheal intubation was avoided and the patient could be discharged from the ICU. During this period follow up arterial blood gases, chest X-rays and CT scans were obtained.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 Patients fulfilling the inclusion criteria were submitted to strapping and packing in the form of dressing and fixing with elastoplast. All patients were ventilated using NIPPV (Engstrom Carestation), which was delivered to the patient through full-face mask and was started with pressure support of 8-12 cmH2O and PEEP of 3-5 cmH2O and gradually increased in 2 cmH2O steps. When patients tolerate FiO2 ≤ 0.5 with pressure support ≤ 8 cmH2O and PEEP ≤ 5 cmH2O for > 6 consecutive hours, withdrawal from NIPPV was attempted daily in 30 minutes spontaneous breathing trials. Therapy was considered successful if endotracheal intubation was avoided and the patient could be discharged from the ICU. During this period follow up arterial blood gases, chest X-rays and CT scans were obtained.

Description

Inclusion Criteria:

  • Patients with multiple fractured ribs with flail segment presented by acute respiratory distress that had deteriorated despite effective pain management, their age more than 18 years and less than 70 years, with thoracic trauma severity score (TTSS) between 5 and 15

Exclusion Criteria:

  • Patients requiring endotracheal intubation or emergency surgery following admission, severe associated trauma to other systems, respiratory failure caused by neurological disease or asthmatic attack or any contraindication for NIPPV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PaO2 mmHg
Time Frame: 24 hours after starting NIPPV
The correlations of pulmonary contusion with PaO2
24 hours after starting NIPPV

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PaO2/FiO2 ratio
Time Frame: 24 hours after starting NIPPV
The correlations of pulmonary contusion with PaO2/FiO2
24 hours after starting NIPPV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed G Abdelraheem, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB0000871241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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