Clinical Trial Results:
A phase IV randomized, controlled clinical trial to compare the high flow oxygen therapy (group of intervention) opposite to the conventional oxygen therapy (group control) in patients with severe acute respiratory failure.
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Summary
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EudraCT number |
2012-001671-36 |
Trial protocol |
ES |
Global end of trial date |
01 Oct 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Feb 2022
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First version publication date |
16 Feb 2022
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Other versions |
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Summary report(s) |
Paper Optiflow |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EC11-103
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Fundación de Investigación Biomédica (FIB) del Hospital Universitario de La Princesa
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Sponsor organisation address |
Calle Diego de León, 62, Madrid, Spain, 28006
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Public contact |
Dpto.EECC, Fundación para la Investigación Biomédica, 34 915202476, eecc.fib.hlpr@salud.madrid.org
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Scientific contact |
Dpto.EECC, Fundación para la Investigación Biomédica, 34 915202476, eecc.fib.hlpr@salud.madrid.org
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Dec 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Oct 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Oct 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
1. To Evaluate if the high flow oxigen therapy with warm system of humidificación by means of nasal glasses (optiflow) opposite to the conventional oxygen therapy like treatment of the severe acute respiratory failure of any etiology determines a minor need of intubation orotraqueal
2. To evaluate if the system optiflow provides a better tolerance and comfort of the patient with severe acute respiratory failure that needs oxygen therapy to high concentrations of oxygen.
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Protection of trial subjects |
The information disseminated and obtained through the implementation of this study is considered confidential and should be treated as such at all times. Study subjects will be identified by the initial letter of their name followed by the subject number in the study. Both the investigators responsible of the clinical trial, as well as a representative of the sponsor or of the Health Authorities, will have access to the information the information recorded throughout the study. In case of publication of the results of the study, the identity of the patients will not be revealed.
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Background therapy |
- | ||
Evidence for comparator |
Conventional oxygen therapy: venturi mask with FiO2 between 60 and 100% | ||
Actual start date of recruitment |
15 Jan 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 46
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Worldwide total number of subjects |
46
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EEA total number of subjects |
46
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
46
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted in the Intensive Care Unit (ICU), University Hospital La Princesa in Madrid (Spain) between January 2013 and December 2015. | ||||||||||||
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Pre-assignment
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Screening details |
Patients older than 18 years, of both sexes, with AHRF of any etiology after signing informed consent. AHRF was defined as: a PaO2/FIO2 ratio ⩽ 200 or SpO2/FIO2 ratio ⩽ 160 (SpO2 = peripheral oxygen saturation by pulse oximetry); and respiratory rate > 30 r/min for at least 30 min. | ||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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High-flow nasal cannula (HFNC) | ||||||||||||
Arm description |
It provides high flow, matching the patient’s inspiratory flow demands, at an ideal temperature and humidity, which improves oxygenation, produces a certain continuous positive pressure effect on airways, reduces proximal airway dead space, and increases respiratory volumes. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Optiflow
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Medicinal gas, compressed
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Routes of administration |
External use
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Dosage and administration details |
Oxygen 50l/min
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Arm title
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Conventional oxygen therapy (COT) | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Ventimask
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Medicinal gas, compressed
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Routes of administration |
External use
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Dosage and administration details |
Oxygen FiO2 60-100%
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Baseline characteristics reporting groups
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Reporting group title |
High-flow nasal cannula (HFNC)
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Reporting group description |
It provides high flow, matching the patient’s inspiratory flow demands, at an ideal temperature and humidity, which improves oxygenation, produces a certain continuous positive pressure effect on airways, reduces proximal airway dead space, and increases respiratory volumes. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Conventional oxygen therapy (COT)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
High-flow nasal cannula (HFNC)
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Reporting group description |
It provides high flow, matching the patient’s inspiratory flow demands, at an ideal temperature and humidity, which improves oxygenation, produces a certain continuous positive pressure effect on airways, reduces proximal airway dead space, and increases respiratory volumes. | ||
Reporting group title |
Conventional oxygen therapy (COT)
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Reporting group description |
- | ||
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End point title |
Intubation | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Overall
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Statistical analysis title |
Statistical analysis Intubation | |||||||||
Statistical analysis description |
A descriptive analysis was carried out, analyzing the comparability of the groups and comparing by intention to treat: bivariate (parametric or nonparametric)
and multivariate (linear regression for repeated measures or Cox proportional risk regression).
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Comparison groups |
High-flow nasal cannula (HFNC) v Conventional oxygen therapy (COT)
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Number of subjects included in analysis |
46
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Regression, Cox | |||||||||
Parameter type |
Cox proportional hazard | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
- | |||||||||
upper limit |
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Variability estimate |
Standard deviation
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End point title |
Discomfort | |||||||||
End point description |
Of the 24 HFNC group patients, 3 subjects did not tolerate the device because of the displeasing heat.
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End point type |
Primary
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End point timeframe |
Overall
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Statistical analysis title |
Statistical analysis Discomfort | |||||||||
Statistical analysis description |
A descriptive analysis was carried out, analyzing the comparability of the groups and comparing by intention to treat: bivariate (parametric or nonparametric)
and multivariate (linear regression for repeated measures or Cox proportional risk regression).
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Comparison groups |
High-flow nasal cannula (HFNC) v Conventional oxygen therapy (COT)
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Number of subjects included in analysis |
46
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Regression, Cox | |||||||||
Parameter type |
Cox proportional hazard | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
- | |||||||||
upper limit |
- | |||||||||
Variability estimate |
Standard deviation
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Adverse events information
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Timeframe for reporting adverse events |
Prospective follow-up will be carried out until hospital discharge or exitus, or if orotracheal intubation is necessary without orotracheal intubation unrelated to respiratory failure (coma of other etiology, surgery, cerebral arteriography, etc.)
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Assessment type |
Systematic | ||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
20
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Reporting groups
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Reporting group title |
HFNC
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Reporting group description |
- | ||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The principal limitation was that participation was offered to one-third of eligible patiens | |||
