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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03326830
Other study ID # CHRO-2017-09
Secondary ID 2017-A01922-51CH
Status Completed
Phase N/A
First received
Last updated
Start date December 21, 2017
Est. completion date August 10, 2022

Study information

Verified date February 2023
Source Centre Hospitalier Régional d'Orléans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Patients with respiratory distress and an SpO2 below 90% in the prehospital setting will be randomized to receive either high-flow nasal oxygen therapy through a dedicated device or standard oxygen therapy through standard devices such as nasal cannula or face mask. Need of mechanical ventilation either invasive or noninvasive from enrollment to day 28 and time course of oxygenation between first SpO2 measured on scene and arrival to the hospital will be the main outcome measures.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
High-flow nasal oxygen
oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher&Paykel, New-Zealand).
Standard oxygen therapy
Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag

Locations

Country Name City State
France CHR d'ORLEANS Orléans
France Brigade des Sapeurs Pompiers de Paris Paris

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (7)

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

Outcome

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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