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CompletedNCT05342103Updated Jan 20, 2023

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

An interventional study of high flow oxygenation in Chest Trauma, sponsored by Huda Fahmy Mahmoud, PhD. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-01-20.

Sponsored by Huda Fahmy Mahmoud, PhD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 40 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Huda Fahmy Mahmoud, PhD is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    High flow nasal cannula (HFNC) group

    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

  • Active comparator
    Continuous positive airway pressure (CPAP) group

    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

  • Procedurehigh flow oxygenation

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

06

What researchers measure

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.

    Time frame: 48 hours

Secondary outcomes

  1. 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)

    Time frame: 48 hours

  2. the perceived effort of breathing with the different modes of oxygen delivery

    will be measured using the modified Borg Scale (0-10)

    Time frame: 48 hours

07

Study locations

1 site
  • Huda Fahmy
    Aswan, 81511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05342103
Lead sponsor
Huda Fahmy Mahmoud, PhD
Responsible party
Huda Fahmy Mahmoud, PhD (Assistant professor of Anesthesia and Intensive Care, Aswan University Hospital) — Sponsor-investigator
First posted
Apr 22, 2022
Start date
Nov 1, 2021
Primary completion
Jan 19, 2023
Completion
Jan 19, 2023
Last update
Jan 20, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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