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Completed

NCT Number: NCT03090308

Pulmonary Contusion Flail Chest Complex

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Noninvasive positive pressure ventilation

Other

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 outcomes

  1. PaO2 mmHg

    Time frame: 24 hours after starting NIPPV

    The correlations of pulmonary contusion with PaO2

Secondary outcomes

  1. PaO2/FiO2 ratio

    Time frame: 24 hours after starting NIPPV

    The correlations of pulmonary contusion with PaO2/FiO2

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2017
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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