Respiratory FailureNCT02481843
Hyperoxia, Erythropoiesis and Microcirculation in Critically Ill Patient
An observational study of Respiratory Failure, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
Prospective observational study in 40 adult critically ill patients. Patients were eligible if they were mechanically ventilated with an FiO2 ≤0.5 and PaO2/FiO2 ≥200 mmHg and hemodynamically stable with a hemoglobin ≥9 g/dL, no acute bleeding or need for blood transfusions, no renal failure, no chronic obstructive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- 2 hours of hyperoxia (FiO2 = 1)
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2013to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18-year old) patients admitted to a 12-bed medical-surgical ICU
Who may be able to join
- Mechanical Ventilated Patients
Who cannot join
- PaO2/FiO2 < 200
- hemoglobin (Hb) <9 g/dL
- acute bleeding or blood transfusions during the study period
- any surgical interventions during the study period
- acute or chronic renal failure
- hemodynamic instability
Show all 9Show fewer
- chronic obstructive pulmonary disease
- pregnancy
- factors impeding the sublingual microcirculation evaluation (oral surgery or facial trauma)
Trial locations and contacts
1 site in 1 country.
Italy1 site
University ICU, AOU Ospedali Riuniti Ancona
Torrette Di Ancona, Ancona, 60126
About this study
Official title: Hyperoxia, Erythropoiesis and Tissue Oxygenation in Critically Ill Patient
Prospective observational study in 40 adult critically ill patients. Patients were eligible if they were mechanically ventilated with an FiO2 ≤0.5 and PaO2/FiO2 ≥200 mmHg and hemodynamically stable with a hemoglobin ≥9 g/dL, no acute bleeding or need for blood transfusions, no renal failure, no chronic obstructive pulmonary disease. Twenty patients (hyperoxia group) underwent a 2-hour exposure to normobaric hyperoxia (FiO2 1.0), 20 patients were evaluated as controls. Serum erythropoietin (EPO) was measured at baseline, 24h and 48h. Serum Glutathione (GSH) and reacting oxygen species (ROS) were assessed at baseline (t0), after 2 hours of hyperoxia (t1) and 2 hours after the return to baseline FiO2 (t2). Sidestream dark field videomicroscopy was applied sublingually to assess the microvascular response to hyperoxia. Near infrared spectroscopy with a vascular occlusion test was applied at t0, t1, t2.
Read the detailed description
Interventions:
Forty patients were enrolled in total. The first 20 patients (hyperoxia group) underwent a 2-hour period of normobaric hyperoxia (FiO2 1.0), according to the protocol applied in. No variation in the FiO2 was applied for the other 20 patients (control group). All patients were enrolled in the morning and hyperoxia was performed in the time range between 10am-2pm in order to minimize variability due to the circadian rhythm of EPO production. No variations to sedation or vasopressor dose were applied during the study period.
Measurements:
On the study day, measurements were taken at 2-hour intervals: baseline (t0), under 1.0 FiO2 (t1) and after returning to baseline FiO2 (t2). These included: body temperature, heart rate (HR), mean arterial pressure (MAP), arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2) and carbon dioxide (PaCO2), PaO2/FiO2, arterial pH, bicarbonate, base excess) and central venous saturation (ScvO2) blood gases, arterial lactates, evaluation of the sublingual microcirculation and tissue oxygenation. The same measurements were performed in the control group at 2-hour intervals. In 24 patients (12 patients per group), arterial blood samples (10 mL) were taken at each time point and immediately centrifuged; plasma and serum were stored at -70°C for subsequent analyses. Serum EPO, reticulocyte count, hemoglobin (Hb) and hematocrit were measured at 8am in all patients on the study day, at 24 and 48 hours.
Microcirculation measurements with sidestream dark field imaging The sublingual microcirculation was evaluated with sidestream dark field (SDF) videomicroscopy (Microscan, Microvision Medical, Amsterdam, NL). This technique has been described in details elsewhere.
Poor-quality images were discarded, and three images for each time point were selected and analyzed by using a computer software package (Automated Vascular Analysis Software; Microvision Medical BV). According to the consensus report on the performance and evaluation of microcirculation using SDF imaging, total vessel density (TVD), perfused vessel density (PVD), De Backer score, proportion of perfused vessels (PPV), microcirculatory flow index (MFI), flow heterogeneity index (FHI) and blood flow velocity (BFV) were calculated in small or medium vessels (diameter ≤ or >20 μm, respectively), as previously described. In addition to discontinuous microvascular measurements at 2-hour intervals, the investigators evaluated the early response of the microcirculation to variations in the FiO2 on one and the same site of sublingual mucosa in order to detect even minute changes in the microvascular density and flow. Directly after obtaining measurements from 5 different sites, the SDF probe was placed in a stable position and manipulated to avoid any pressure artifacts or secretions interfering with the analysis. By manually supporting the microscope, continuous video recording was performed for at least 2 minutes during the variation of the FiO2 (start or end of hyperoxia). Video clips of 10 s (2 per time point) corresponding to before (baseline or 2h FiO2 1.0) and after (2 min FiO2 1.0 or 2 min after returning to baseline FiO2) the variation of FiO2 were subsequently selected and analyzed.
Evaluation of peripheral tissue oxygenation and microvascular reactivity with near infrared spectroscopy.
Near-infrared reflectance spectrophotometry (NIRS) (InSpectra™ Model 650; Hutchinson Technology Inc., Hutchinson, USA) was used to measure peripheral tissue oxygen saturation (StO2) and tissue Hb index (THI) at baseline and during a vascular occlusion test (VOT). A 15 mm-sized probe was placed on the skin of the thenar eminence, and a sphygmomanometer cuff was placed around the (upper) arm to occlude the brachial artery. After a 3-minute period of StO2 signal stabilization, arterial inflow was arrested by inflation of the cuff to 50 mmHg above the systolic arterial pressure. The cuff was kept inflated until the StO2 decreased to 40% and then released. StO2 was continuously recorded during the reperfusion phase until stabilization. The StO2 downslope (%/minute) was calculated from the regression line of the first minute of StO2 decay after occlusion, providing an index of O2 consumption rate. The StO2 upslope (%/minute) was obtained from the regression line of StO2 increase in the reperfusion phase. The area under the curve (AUC) of the hyperemic response was also calculated. StO2 upslope and the AUC of the StO2 reflect microvascular reactivity. All the parameters were calculated by using a computer software package (version 3.03 InSpectra Analysis Program; Hutchinson Technology Inc.).
Immunoassays :
Levels of ROS and GSH were measured in accordance with the instructions of the manufacturer.
Statistical analysis:
Statistical analysis was performed by using GraphPad Prism version 6 (GraphPad Software, USA). Normality of distribution was checked by using the Kolmogorov-Smirnov test. Data were presented as mean ± standard deviation or median [1st-3rd quartile], as appropriate. One-way analysis of variance (ANOVA) for repeated measures with Bonferroni post-hoc test or Friedman test with Dunn's multiple comparison test were used to evaluate changes over time in the same group. Two-way ANOVA for repeated measures with Bonferroni post-hoc test was used to evaluate differences between the two groups, where applicable. For non-normally distributed variables, the Mann-Whitney U test was applied to evaluate difference between the two groups at the same time point. A Spearman correlation coefficient was calculated to assess correlations between variables. The alpha level of significance was set a priori at 0.05.
- Conditions
- Respiratory Failure
- Being tested
- 2 hours of hyperoxia (FiO2 = 1)
- Keywords
- Hyperoxia, Microcirculation, Erythropoietin, Normobaric Oxygen Paradox
- Medical subject headings
- Respiratory Insufficiency, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 hours of hyperoxia (FiO2 = 1)Other
Also called Hyperoxia
Patients received 2 hours of hyperoxia at FiO2 = 1
| Study group | Role | What they receive |
|---|---|---|
| Hyperoxia | 2-hours of hyperoxia (FiO2 = 1.0) Receives: Other: 2 hours of hyperoxia (FiO2 = 1) | |
| Control | 2-hours control without hyperoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients
Blood samples to detect erythropoietin
Measured: up to 2 day after FiO2=1 exposure
Secondary outcomes (7)
Effects of hyperoxia on the sublingual microcirculation
SDF technique will be used to look at sublingual microcirculation, 20 seconds movies are registered and software is used to analyze them
Measured: Before FiO2, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Effects of hyperoxia on the peripheral microcirculation
Near Infra-Red Spectroscopy is used to assess oxygen tissue saturation at thenar and vascular occlusion test is performed to assess the desaturation and resaturation curves
Measured: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Hyperoxia and variations in circulating glutathione
Blood samples
Measured: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Hyperoxia and variations in circulating nitric oxide
Blood samples
Measured: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Hyperoxia and variations in circulating ROS
Blood samples
Measured: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Reticulocyte Count
Measured: Before FiO2 = 1, at 1 day and 2 day after FiO2=1 exposure
Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients after 1 day
Measured: Before FIO2 = 1 and at 1 day after FiO2 = 1 exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startApr 2013
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abele Donati, MD, Università Politecnica delle Marche
- Investigators
- Abele Donati, MD, Principal investigator, AOU Ospedali Riuniti Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481843
- Sponsor's protocol ID
- NOP001
- Status last verified
- Jul 2015
- First submitted
- 15 Jun 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Donati A, Damiani E, Zuccari S, Domizi R, Scorcella C, Girardis M, Giulietti A, Vignini A, Adrario E, Romano R, Mazzanti L, Pelaia P, Singer M. Effects of short-term hyperoxia on erythropoietin levels and microcirculation in critically Ill patients: a prospective observational pilot study. BMC Anesthesiol. 2017 Mar 23;17(1):49. doi: 10.1186/s12871-017-0342-2.
PubMed 28335733
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperoxia, Erythropoiesis and Tissue Oxygenation in Critically Ill Patient
- ClinicalTrials.gov ID
- NCT02481843
- Acronym / sponsor ID
- NOP001
- Conditions
- Respiratory Failure
- Keywords
- Hyperoxia, Microcirculation, Erythropoietin, Normobaric Oxygen Paradox
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective observational study in 40 adult critically ill patients. Patients were eligible if they were mechanically ventilated with an FiO2 ≤0.5 and PaO2/FiO2 ≥200 mmHg and hemodynamically stable with a hemoglobin ≥9 g/dL, no acute bleeding or need for blood transfusions, no renal failure, no chronic obstructive pulmonary disease. Twenty patients (hyperoxia group) underwent a 2-hour exposure to normobaric hyperoxia (FiO2 1.0), 20 patients were evaluated as controls. Serum erythropoietin (EPO) was measured at baseline, 24h and 48h. Serum Glutathione (GSH) and reacting oxygen species (ROS) were assessed at baseline (t0), after 2 hours of hyperoxia (t1) and 2 hours after the return to baseline FiO2 (t2). Sidestream dark field videomicroscopy was applied sublingually to assess the microvascular response to hyperoxia. Near infrared spectroscopy with a vascular occlusion test was applied at t0, t1, t2.
Detailed description
Interventions:
Forty patients were enrolled in total. The first 20 patients (hyperoxia group) underwent a 2-hour period of normobaric hyperoxia (FiO2 1.0), according to the protocol applied in. No variation in the FiO2 was applied for the other 20 patients (control group). All patients were enrolled in the morning and hyperoxia was performed in the time range between 10am-2pm in order to minimize variability due to the circadian rhythm of EPO production. No variations to sedation or vasopressor dose were applied during the study period.
Measurements:
On the study day, measurements were taken at 2-hour intervals: baseline (t0), under 1.0 FiO2 (t1) and after returning to baseline FiO2 (t2). These included: body temperature, heart rate (HR), mean arterial pressure (MAP), arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2) and carbon dioxide (PaCO2), PaO2/FiO2, arterial pH, bicarbonate, base excess) and central venous saturation (ScvO2) blood gases, arterial lactates, evaluation of the sublingual microcirculation and tissue oxygenation. The same measurements were performed in the control group at 2-hour intervals. In 24 patients (12 patients per group), arterial blood samples (10 mL) were taken at each time point and immediately centrifuged; plasma and serum were stored at -70°C for subsequent analyses. Serum EPO, reticulocyte count, hemoglobin (Hb) and hematocrit were measured at 8am in all patients on the study day, at 24 and 48 hours.
Microcirculation measurements with sidestream dark field imaging The sublingual microcirculation was evaluated with sidestream dark field (SDF) videomicroscopy (Microscan, Microvision Medical, Amsterdam, NL). This technique has been described in details elsewhere.
Poor-quality images were discarded, and three images for each time point were selected and analyzed by using a computer software package (Automated Vascular Analysis Software; Microvision Medical BV). According to the consensus report on the performance and evaluation of microcirculation using SDF imaging, total vessel density (TVD), perfused vessel density (PVD), De Backer score, proportion of perfused vessels (PPV), microcirculatory flow index (MFI), flow heterogeneity index (FHI) and blood flow velocity (BFV) were calculated in small or medium vessels (diameter ≤ or >20 μm, respectively), as previously described. In addition to discontinuous microvascular measurements at 2-hour intervals, the investigators evaluated the early response of the microcirculation to variations in the FiO2 on one and the same site of sublingual mucosa in order to detect even minute changes in the microvascular density and flow. Directly after obtaining measurements from 5 different sites, the SDF probe was placed in a stable position and manipulated to avoid any pressure artifacts or secretions interfering with the analysis. By manually supporting the microscope, continuous video recording was performed for at least 2 minutes during the variation of the FiO2 (start or end of hyperoxia). Video clips of 10 s (2 per time point) corresponding to before (baseline or 2h FiO2 1.0) and after (2 min FiO2 1.0 or 2 min after returning to baseline FiO2) the variation of FiO2 were subsequently selected and analyzed.
Evaluation of peripheral tissue oxygenation and microvascular reactivity with near infrared spectroscopy.
Near-infrared reflectance spectrophotometry (NIRS) (InSpectra™ Model 650; Hutchinson Technology Inc., Hutchinson, USA) was used to measure peripheral tissue oxygen saturation (StO2) and tissue Hb index (THI) at baseline and during a vascular occlusion test (VOT). A 15 mm-sized probe was placed on the skin of the thenar eminence, and a sphygmomanometer cuff was placed around the (upper) arm to occlude the brachial artery. After a 3-minute period of StO2 signal stabilization, arterial inflow was arrested by inflation of the cuff to 50 mmHg above the systolic arterial pressure. The cuff was kept inflated until the StO2 decreased to 40% and then released. StO2 was continuously recorded during the reperfusion phase until stabilization. The StO2 downslope (%/minute) was calculated from the regression line of the first minute of StO2 decay after occlusion, providing an index of O2 consumption rate. The StO2 upslope (%/minute) was obtained from the regression line of StO2 increase in the reperfusion phase. The area under the curve (AUC) of the hyperemic response was also calculated. StO2 upslope and the AUC of the StO2 reflect microvascular reactivity. All the parameters were calculated by using a computer software package (version 3.03 InSpectra Analysis Program; Hutchinson Technology Inc.).
Immunoassays :
Levels of ROS and GSH were measured in accordance with the instructions of the manufacturer.
Statistical analysis:
Statistical analysis was performed by using GraphPad Prism version 6 (GraphPad Software, USA). Normality of distribution was checked by using the Kolmogorov-Smirnov test. Data were presented as mean ± standard deviation or median [1st-3rd quartile], as appropriate. One-way analysis of variance (ANOVA) for repeated measures with Bonferroni post-hoc test or Friedman test with Dunn's multiple comparison test were used to evaluate changes over time in the same group. Two-way ANOVA for repeated measures with Bonferroni post-hoc test was used to evaluate differences between the two groups, where applicable. For non-normally distributed variables, the Mann-Whitney U test was applied to evaluate difference between the two groups at the same time point. A Spearman correlation coefficient was calculated to assess correlations between variables. The alpha level of significance was set a priori at 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperoxia | – | Other: 2 hours of hyperoxia (FiO2 = 1)2-hours of hyperoxia (FiO2 = 1.0) |
| Control | – | –2-hours control without hyperoxia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18-year old) patients admitted to a 12-bed medical-surgical ICU
Key inclusion criteria (1 listed)
- Mechanical Ventilated Patients
Key exclusion criteria (9 listed)
- PaO2/FiO2 < 200
- hemoglobin (Hb) <9 g/dL
- acute bleeding or blood transfusions during the study period
- any surgical interventions during the study period
- acute or chronic renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 hours of hyperoxia (FiO2 = 1)Also: HyperoxiaPatients received 2 hours of hyperoxia at FiO2 = 1 | Other | Hyperoxia |
Primary outcome
Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients
Time frame: up to 2 day after FiO2=1 exposure
Blood samples to detect erythropoietin
7 secondary outcomes
Effects of hyperoxia on the sublingual microcirculation
Time frame: Before FiO2, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Effects of hyperoxia on the peripheral microcirculation
Time frame: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Hyperoxia and variations in circulating glutathione
Time frame: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Hyperoxia and variations in circulating nitric oxide
Time frame: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Hyperoxia and variations in circulating ROS
Time frame: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure
Reticulocyte Count
Time frame: Before FiO2 = 1, at 1 day and 2 day after FiO2=1 exposure
Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients after 1 day
Time frame: Before FIO2 = 1 and at 1 day after FiO2 = 1 exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- Derived from this study: PubMed 28335733Donati A, Damiani E, Zuccari S, Domizi R, Scorcella C, Girardis M, Giulietti A, Vignini A, Adrario E, Romano R, Mazzanti L, Pelaia P, Singer M. Effects of short-term hyperoxia on erythropoietin levels and microcirculation in critically Ill patients: a prospective observational pilot study. BMC Anesthesiol. 2017 Mar 23;17(1):49. doi: 10.1186/s12871-017-0342-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abele Donati, MD principal investigator
AOU Ospedali Riuniti Ancona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Università Politecnica delle Marche at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients (time frame: up to 2 day after FiO2=1 exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.