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Pulmonary Contusion Flail Chest Complex

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ClinicalTrials.gov Identifier: NCT03090308
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Abdelrady S Ibrahim, MD, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Contusion Other: Noninvasive positive pressure ventilation

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Days
Official Title: Impact of Pulmonary Contusion in Patient's Outcome When Associated With Traumatic Flail Chest: An Observational Study
Actual Study Start Date : April 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bruises


Intervention Details:
  • Other: Noninvasive positive pressure ventilation
    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.


Primary Outcome Measures :
  1. PaO2 mmHg [ Time Frame: 24 hours after starting NIPPV ]
    The correlations of pulmonary contusion with PaO2


Secondary Outcome Measures :
  1. PaO2/FiO2 ratio [ Time Frame: 24 hours after starting NIPPV ]
    The correlations of pulmonary contusion with PaO2/FiO2



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090308


Locations
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Egypt
Assiut university faculty of medicine
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Mohamed G Abdelraheem, MD Assiut University

Additional Information:

Publications:
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Responsible Party: Abdelrady S Ibrahim, MD, Assistant professor of anesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT03090308     History of Changes
Other Study ID Numbers: IRB0000871241
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Contusions
Flail Chest
Wounds, Nonpenetrating
Wounds and Injuries
Thoracic Injuries