High Flow Nasal Oxygenation Versus Non-invasive Ventilation for Patients With Blunt Chest Trauma
Primary Purpose
Chest Trauma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high flow oxygenation
Sponsored by
About this trial
This is an interventional treatment trial for Chest Trauma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Huda Fahmy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High flow nasal cannula (HFNC) group
Continuous positive airway pressure (CPAP) group
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
the Comfort levels with the different modes of oxygen delivery
will be measured using a 5-point with Likert Scale (marked improvement, slight improvement, no change, slight deterioration, or marked deterioration)
the perceived effort of breathing with the different modes of oxygen delivery
will be measured using the modified Borg Scale (0-10)
Full Information
NCT ID
NCT05342103
First Posted
April 18, 2022
Last Updated
January 19, 2023
Sponsor
Huda Fahmy Mahmoud, PhD
1. Study Identification
Unique Protocol Identification Number
NCT05342103
Brief Title
High Flow Nasal Oxygenation Versus Non-invasive Ventilation for Patients With Blunt Chest Trauma
Official Title
High Flow Nasal Oxygenation Versus Non-invasive Ventilation for Patients With Blunt Chest Trauma: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
January 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Huda Fahmy Mahmoud, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
In the past years, High-flow nasal cannula oxygen (HFNC) has gained an important popularity among intensivest to manage patients with acute respiratory failure, filling a gap in the ventilatory support escalation between facemask oxygen and non-invasive or invasive mechanical ventilation. Interestingly, the use of HFNC was widely and rapidly adopted in ICUs.A unique feature of HFNC is its ability to comfortably deliver high flows of warmed humidified gas, 20-70 L min, with a FiO2 range of 0.21-1.0. Physiological responses to HFNC therapy include increases in airway pressure, end-expiratory lung volume (EELV), and oxygenation which are probably optimal with higher flows (60-70 L/min), while the effects on dead-space washout work of breathing, and respiratory rate may be obtained with intermediate flows (20-45 L/min).
Many studies have found that high flow nasal oxygen is much better tolerated by patients compared to non-invasive ventilation, which may improve compliance. Nevertheless, there is no clear consensus on the treatment outcomes (such as intubation rate, escalated respiratory support rate, and mortality) of high flow nasal oxygenation versus non-invasive ventilation for patients with traumatic chest injuries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High flow nasal cannula (HFNC) group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Continuous positive airway pressure (CPAP) group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
high flow oxygenation
Intervention Description
All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
Primary Outcome Measure Information:
Title
the rate of intubation for mechanical ventilation
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
the Comfort levels with the different modes of oxygen delivery
Description
will be measured using a 5-point with Likert Scale (marked improvement, slight improvement, no change, slight deterioration, or marked deterioration)
Time Frame
48 hours
Title
the perceived effort of breathing with the different modes of oxygen delivery
Description
will be measured using the modified Borg Scale (0-10)
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Huda Fahmy
City
Aswan
ZIP/Postal Code
81511
Country
Egypt
12. IPD Sharing Statement
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High Flow Nasal Oxygenation Versus Non-invasive Ventilation for Patients With Blunt Chest Trauma
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