High Flow Nasal Oxygenation Versus Non-invasive Ventilation for Patients With Blunt Chest Trauma

NCT05342103 | Completed

• 1 other identifier: 559/9/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chest trauma remains an issue for health services for both severe and apparently mild trauma management. Severe chest trauma is associated with high mortality and is liable for 25% of mortality in multiple traumas. Moreover, mild trauma is also associated with significant morbidity, especially in patients with preexisting conditions. Thus, whatever the severity, a fast-acting strategy must be organized. In order to improve the prognosis of patients with severe chest trauma, early and continuous application of non-invasive mechanical ventilation (NIV) can indeed reduce the need for intubation and shorten intensive care unit length-of-stay. Among different mechanisms, the early use of positive end-expiratory pressure after chest trauma, when feasible, seems mandatory to optimize oxygenation and improve clinical outcomes. Indeed, interventions aimed at preventing ARDS after chest trauma carry the greatest potential to reduce the substantial morbidity, mortality, and resource utilization associated with this syndrome.

Conditions

Chest Trauma

Outcome Measures

Primary Outcomes (1)

• the rate of intubation for mechanical ventilation

  Intubation criteria included a respiratory rate of \>40 breaths per minute, signs of increased breathing effort, SpO2 of \<90% despite high FiO2 or acidosis with a pH of \<7.35,occurrence of hemodynamic instability or deterioration of neurologic status.

  48 hours

Secondary Outcomes (2)

• the Comfort levels with the different modes of oxygen delivery

  48 hours

• the perceived effort of breathing with the different modes of oxygen delivery

  48 hours

Study Arms (2)

High flow nasal cannula (HFNC) group

ACTIVE COMPARATOR

All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. The flow rate will be set at 60 L/min

Procedure: high flow oxygenation

Continuous positive airway pressure (CPAP) group

ACTIVE COMPARATOR

All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. Pressure will be set to 3 cm H2O for 5 minutes, then titrated according to patient comfort and tolerance, as well as clinical observation

Procedure: high flow oxygenation

Interventions

high flow oxygenation PROCEDURE

All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.

Continuous positive airway pressure (CPAP) group; High flow nasal cannula (HFNC) group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Rib fractures, pulmonary contusion, and admission within 24 h of injury
• Hypoxemia (SpO2 90 % while breathing 10 l/min oxygen in the ER), or hypercapnia (PaCO2 45 mm Hg) on study entry
• respiratory rate 25/ min despite an optimized intravenous analgesia
• No indication of mechanical ventilation at the time of admission to the intensive care unit

You may not qualify if:

• Patients \< 18 years old
• Patient already admitted to ICU on mechanical ventilation
• requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause
• facial fractures or base of skull fractures
• Who did not receive a chest computed tomography (CT) scan
• Glasgow Coma Scale ≤ 12

Sponsors & Collaborators

• Huda Fahmy Mahmoud, PhD: lead

Study Sites (1)

Huda Fahmy

Aswān, 81511, Egypt

Location

MeSH Terms

Conditions

Thoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of Anesthesia and Intensive Care

Model Details: The patients will be randomly allocated into two groups; patients will receive high-flow nasal oxygenation via nasal cannula (HFNC) or continuous positive airway pressure (CPAP)

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: November 1, 2021
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: January 20, 2023

Record last verified: 2022-11

Locations

EG (1)