Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Effects of supplemental oxygen on systemic and cerebral hemodynamics in experimental hypovolemia: A randomized, phase IV, crossover study to study the effect of supplemental oxygen vs. room air on cerebral and systemic hemodynamics in healthy volunteers > 18 years during experimental hypovolemia in the lower body negative pressure model of hypovolemia.

    Summary
    EudraCT number
    		 2021-003238-35
    Trial protocol
    		 NO  
    Global end of trial date
    14 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2023
    First version publication date
    13 Jul 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    4_141221
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05150418
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Regional Committees for Medical Research Ethics - : 285164
    Sponsors
    Sponsor organisation name
    Oslo University Hospital
    Sponsor organisation address
    Kirkeveien 166, Oslo, Norway, 0450
    Public contact
    Department of Anesthesiology, Oslo University Hospital, 47 22119690, lars.oivind.hoiseth@hotmail.com
    Scientific contact
    Department of Anesthesiology, Oslo University Hospital, 90749409 22119690, lars.oivind.hoiseth@hotmail.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Supplemental oxygen is frequently administered in acutely and critically ill patients, specifically, it is often administered in trauma patients to avoid arterial hypoxemia and tissue hypoxia. There is also an increasing focus on potentially deleterious effects of hyperoxia. Further, the hemodynamic response to hyperoxia in hypovolemia is poorly understood. The present study aims to investigate the effects of supplemental oxygen on systemic and cerebral hemodynamics in simulated hypovolemia in healthy volunteers.
    Protection of trial subjects
    The trial was carried out in accordance with the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Fifteen helathy volunteers were included in this single-centre study performed at Oslo University Hospital, Aker. First visit of first subject was December 2021, and last visit of last subject was June 2022.

    Pre-assignment
    Screening details
    		 Sixteen subjects were screened for participation. Fifteen subjects entered and completed all visits.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    The trial was blinded with a crossover design. Two treatments were administered; medical air and 100% oxygen. Subjects, investigators present during the visits were blinded. Analysis of primary outcome was performed before unblinding.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Medical air
    Arm description
    		 Inhalation of medical air, 21% oxygen, 79% nitrogen.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Medisinsk luft (Air Liquide (medicin.dkAir Liquide Gas AB))
    Investigational medicinal product code
    V03A N05
    Other name
    Pharmaceutical forms
    Medicinal gas, liquefied
    Routes of administration
    Inhalation use
    Dosage and administration details
    Inhalation om mask with rebreather, 15 litres/minute.

    Arm title
    		 Oxygen
    Arm description
    		 Inhalation 100% oxygen.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxygen, Conoxia
    Investigational medicinal product code
    V03A N01
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    Inhalation om mask with rebreather, 15 litres/minute.

    Number of subjects in period 1
    		Medical air Oxygen
    Started
    15
    15
    Completed
    15
    15

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 8 8

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Medical air
    Reporting group description
    		 Inhalation of medical air, 21% oxygen, 79% nitrogen.

    Reporting group title
    Oxygen
    Reporting group description
    		 Inhalation 100% oxygen.

    Primary: Cardiac output

    		 Close Top of page
    End point title
    		 Cardiac output
    End point description
    Effect of treatment on cardiac output during lower body negative pressure.
    End point type
    Primary
    End point timeframe
    During experimental intervention, approximately 30 min.
    End point values
    		 Medical air Oxygen
    Number of subjects analysed
    15
    15
    Units: litres/minute
        arithmetic mean (confidence interval 95%)
    -0.22 (-0.26 to -0.19)
    0.031 (-0.0152 to 0.077)
    Statistical analysis title
    		 Oxygen vs. medical air.
    Statistical analysis description
    Effect of oxygen compared to medical air on change in cardiac output during lower body negative pressure.
    Comparison groups
    Medical air v Oxygen
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.188 [1]
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.031
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.015
         upper limit
    		 0.077
    Notes
    [1] - There was no statistically significant effect of oxygen compared to air on the changes in cardiac output during LBNP (0.031 L/min/LBNP level, 95% CI: - 0.015 to 0.077, P = 0.188).

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All AEs and SAEs were collected from the start of intervention until end of the last visit at the time points specified in the Protocol/ SoA.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Medical air
    Reporting group description
    		 Inhalation of medical air, 21% oxygen, 79% nitrogen.

    Reporting group title
    Oxygen
    Reporting group description
    		 Inhalation 100% oxygen.

    Serious adverse events
    		 Medical air Oxygen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Medical air Oxygen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 15 (0.00%)
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Pharyngitis
    Additional description: "Sore throat". No treatment needed (common cold).
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 18:02:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA