Acute Respiratory Failure With Hypoxia Clinical Trial
— PRHOXY-1Official title:
Prehospital High-Flow Nasal Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: A Randomized, Open-label, Bi-center, Pilot Study
Verified date | February 2023 |
Source | Centre Hospitalier Régional d'Orléans |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the present project is to compare High-Flow Nasal Oxygen therapy with Standard Oxygen therapy, initiated in the prehospital setting in patients with acute hypoxemia respiratory failure, in terms of oxygenation at arrival to the hospital and need of mechanical ventilation during the subsequent 28 days
Status | Completed |
Enrollment | 58 |
Est. completion date | August 10, 2022 |
Est. primary completion date | August 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - First SpO2 on scene <90% - At least one other sign of respiratory distress defined by (a) respiratory distress with a respiratory rate = 25/min; (b) laboured breathing - No advance directives or known decisions of Do Not intubate or Do Not Ventilate order. Exclusion Criteria: - Known COPD or other hypercapnic chronic respiratory failure - age <18 years - Pregnancy or breastfeeding - Anatomical factors precluding the use of a nasal cannula - Emergency intubation required - Patients with tracheostomy - Patient transported to a hospital not involved in the study |
Country | Name | City | State |
---|---|---|---|
France | CHR d'ORLEANS | Orléans | |
France | Brigade des Sapeurs Pompiers de Paris | Paris |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional d'Orléans |
France,
Fontanari P, Burnet H, Zattara-Hartmann MC, Jammes Y. Changes in airway resistance induced by nasal inhalation of cold dry, dry, or moist air in normal individuals. J Appl Physiol (1985). 1996 Oct;81(4):1739-43. doi: 10.1152/jappl.1996.81.4.1739. — View Citation
Kelly AM, Holdgate A, Keijzers G, Klim S, Graham CA, Craig S, Kuan WS, Jones P, Lawoko C, Laribi S; AANZDEM study group. Epidemiology, prehospital care and outcomes of patients arriving by ambulance with dyspnoea: an observational study. Scand J Trauma Resusc Emerg Med. 2016 Sep 22;24(1):113. doi: 10.1186/s13049-016-0305-5. — View Citation
Leonard S, Strasser W, Whittle JS, Volakis LI, DeBellis RJ, Prichard R, Atwood CW Jr, Dungan GC 2nd. Reducing aerosol dispersion by high flow therapy in COVID-19: High resolution computational fluid dynamics simulations of particle behavior during high velocity nasal insufflation with a simple surgical mask. J Am Coll Emerg Physicians Open. 2020 Jun 11;1(4):578-591. doi: 10.1002/emp2.12158. eCollection 2020 Aug. — View Citation
Li J, Fink JB, Ehrmann S. High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion. Eur Respir J. 2020 May 14;55(5):2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May. — View Citation
Prekker ME, Feemster LC, Hough CL, Carlbom D, Crothers K, Au DH, Rea TD, Seymour CW. The epidemiology and outcome of prehospital respiratory distress. Acad Emerg Med. 2014 May;21(5):543-50. doi: 10.1111/acem.12380. — View Citation
Sim MA, Dean P, Kinsella J, Black R, Carter R, Hughes M. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia. 2008 Sep;63(9):938-40. doi: 10.1111/j.1365-2044.2008.05536.x. Epub 2008 Jun 6. — View Citation
Stiell IG, Spaite DW, Field B, Nesbitt LP, Munkley D, Maloney J, Dreyer J, Toohey LL, Campeau T, Dagnone E, Lyver M, Wells GA; OPALS Study Group. Advanced life support for out-of-hospital respiratory distress. N Engl J Med. 2007 May 24;356(21):2156-64. doi: 10.1056/NEJMoa060334. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | need of mechanical ventilation | cumulative incidence of the use of tracheal intubation or noninvasive ventilation (whichever comes first) from enrolment to day 28 | 28 days | |
Secondary | Hypoxemia | Frequency of hypoxemia, defined as sustained (at least 5 min) SpO2 below 90% (SpO2 will be continuously recorded throughout the prehospital medical care period) from the beginning of the intervention period until arrival at Emergency Department or other hospital ward. | 1 hour | |
Secondary | Severe hypoxemia | Frequency of severe hypoxemia, defined as sustained (at least 5 min) SpO2 below 85% from the beginning of the intervention period until arrival at Emergency Department or other hospital ward. | 1 hour | |
Secondary | Survival | Probability of survival from inclusion to day 28 | 28 days | |
Secondary | SpO2 | Time course of SpO2 | 1 hour | |
Secondary | Respiratory rate | Time course of respiratory rate | 1 hour | |
Secondary | Heart rate | Time course of heart rate | 1 hour | |
Secondary | Tracheal intubation | Cumulative incidence of tracheal intubation from inclusion to day 28. | 28 days | |
Secondary | Noninvasive ventilation | Cumulative incidence of noninvasive ventilation use for acute respiratory failure from inclusion to day 28 | 28 days | |
Secondary | arterial pH | arterial pH (units) measured at hospital arrival | 1 hour | |
Secondary | arterial PaCO2 | arterial PaCO2 (mmHg) measured at hospital arrival | 1 hour | |
Secondary | arterial PaO2 | arterial PaO2 (mmHg) measured at hospital arrival | 1 hour | |
Secondary | Dyspnea | Dyspnea intensity as assessed by the patient him/herself at hospital arrival using the following dyspnea score: frank improvement: +2; mild improvement: +1; No change: 0; slight worsening: -1; frank worsening:-2. | 1 hour | |
Secondary | Serious Adverse Events | The number of serious adverse events during the intervention phase of the study | Day 28 |
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