Pulmonary Contusion Flail Chest Complex

Pulmonary Contusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090308
• Other study ID #: IRB0000871241
• Status: Completed
• Phase: N/A
• First received: March 15, 2017
• Last updated: March 20, 2017
• Start date: April 2013
• Est. completion date: July 2016

Study information

• Verified date: March 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contusions
• Flail Chest
• Pulmonary Contusion

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2 mmHg	The correlations of pulmonary contusion with PaO2	24 hours after starting NIPPV
Secondary	PaO2/FiO2 ratio	The correlations of pulmonary contusion with PaO2/FiO2	24 hours after starting NIPPV