Acute Respiratory FailureNCT02598492
Imputation of PaO2 From SaO2
An observational study of Acute Respiratory Failure, run by Brigham and Women's Hospital at 3 sites in 2 countries.
Trial summary
The aims of this study are (1) to find out the relationship between PaO2 and SaO2 among mechanically ventilated patients and (2) to create a reliable system to utilize SF ratios to impute the PF ratios in assessing the respiratory parameter of the SOFA score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- arterial blood gas
- How many people
- 646 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Sep 2015to 31 Dec 2020
- How long will I take part?
- 1 Year
- 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: Adults > 18 years old who are invasively mechanically ventilated in an ED or ICU
Who may be able to join
- Mechanically ventilated patient in a participating ICU or ED.
- Arterial blood gas ordered and obtained for clinical reasons.
Who cannot join
- Age < 18 years
- Pregnancy
- Prisoners
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
PLA General Hospital
Beijing
Guangzhou Red Cross Hospital
Guangzhou, Guangdong
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Imputation of PaO2 From SaO2 in the Respiratory Component of the Sequential Organ Failure Assessment (SOFA) Score
The aims of this study are (1) to find out the relationship between PaO2 and SaO2 among mechanically ventilated patients and (2) to create a reliable system to utilize SF ratios to impute the PF ratios in assessing the respiratory parameter of the SOFA score.
Read the detailed description
The Sequential Organ Failure Assessment (SOFA) score is validated as a measure of severity of illness over time in intensive care unit (ICU) patients and can be used to follow the course of organ dysfunction and response to treatment1. SOFA has become a frequently used scoring system of patients in multi-organ failure, given its high sensitivity and specificity as a predictor of morbidity and mortality in critically ill patients2. The severity of respiratory dysfunction is measured in the SOFA score by PaO2/FiO2 (PF) ratio, which is also used as a measure of severity of hypoxemia in patients with acute respiratory distress syndrome (ARDS).
An invasive sampling of arterial blood gas (ABG) is required to measure the PaO2 for the PF. Often, patients with less severe hypoxemia may not clinically undergo ABG testing on a routine basis; hence the clinical and research utility of the SOFA scoring system is reduced. Furthermore, previous studies revealed concerns about anemia following repeated blood sampling; hence, the tendency to implement less invasive approaches have led to less frequent ABG measurements in critically ill patients3. However, almost all ICU patients are monitored with pulse oximeters, which measure the percent saturation of hemoglobin with oxygen (SpO2). Whether SpO2 can be used to impute PaO2 for determining the PF ratio has not been robustly evaluated in a prospective study of critically ill patients.
Prior work investigating the association between PaO2 and SpO2 includes a post hoc study of ARDS Network patients4. This study excluded patients at altitude, used a linear model for a highly non-linear relationship, and could not determine whether SpO2 and PaO2 were simultaneously measured. A similar approach was applied to ARDS Network patients to derive an SpO2-based respiratory subscore of the SOFA score5. Several similar, retrospective studies have been performed in mechanically ventilated children, consistently using linear models of correlation between SF and PF ratios, with similar limitations6-9.
The Ellis inversion10 of the Severinghaus equation11 provides a useful non-linear method for imputing PaO2 from SaO2. This technique has been used in multiple cohorts of patients with pneumonia12-14. This simple calculation can be improved by incorporating PaCO2 and pH values, which could be available from venous blood gases that may be obtained in patients without arterial catheters. Because Severinghaus/Ellis estimates SaO2, a method for estimating SaO2 from SpO2 is necessary. There is no current validated and reliable method for calculating SaO2 on the basis of a measured SpO2. Skin pigmentation affects accuracy of SpO2, as do sex and oximeter type15,16.
The aims of this study are (1) to find out the relationship between PaO2 and SaO2 among mechanically ventilated patients and (2) to create a reliable system to utilize SF ratios to impute the PF ratios in assessing the respiratory parameter of the SOFA score.
- Conditions
- Acute Respiratory Failure
- Being tested
- arterial blood gas
- Keywords
- Mechanical Ventilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial blood gasOther
Also called oxygena saturation
Just record clinical lab data
| Study group | Role | What they receive |
|---|---|---|
| Imputation of SF to PF | Patients required invasive mechanical ventilation within 6 hours after intubation Receives: Other: arterial blood gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the relationship between PaO2 and SaO2 among mechanically ventilated patients
Measured: one year
Secondary outcomes (1)
To utilize SF ratios to impute the PF ratios in assessing the respiratory parameter of the SOFA score
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start1 Sep 2015
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 646 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Guangzhou Red Cross Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Peter Chuanyi Hou, Brigham and Women's Hospital
- Investigators
- Peter C Hou, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598492
- Sponsor's protocol ID
- 2015P001945
- Status last verified
- Mar 2022
- First submitted
- 4 Nov 2015
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
PubMed 9824069Vincent JL, Ferreira F, Moreno R. Scoring systems for assessing organ dysfunction and survival. Crit Care Clin. 2000 Apr;16(2):353-66. doi: 10.1016/s0749-0704(05)70114-7.
PubMed 10768086Ferguson ND, Frutos-Vivar F, Esteban A, Fernandez-Segoviano P, Aramburu JA, Najera L, Stewart TE. Acute respiratory distress syndrome: underrecognition by clinicians and diagnostic accuracy of three clinical definitions. Crit Care Med. 2005 Oct;33(10):2228-34. doi: 10.1097/01.ccm.0000181529.08630.49.
PubMed 16215375Rice TW, Wheeler AP, Bernard GR, Hayden DL, Schoenfeld DA, Ware LB; National Institutes of Health, National Heart, Lung, and Blood Institute ARDS Network. Comparison of the SpO2/FIO2 ratio and the PaO2/FIO2 ratio in patients with acute lung injury or ARDS. Chest. 2007 Aug;132(2):410-7. doi: 10.1378/chest.07-0617. Epub 2007 Jun 15.
PubMed 17573487Pandharipande PP, Shintani AK, Hagerman HE, St Jacques PJ, Rice TW, Sanders NW, Ware LB, Bernard GR, Ely EW. Derivation and validation of Spo2/Fio2 ratio to impute for Pao2/Fio2 ratio in the respiratory component of the Sequential Organ Failure Assessment score. Crit Care Med. 2009 Apr;37(4):1317-21. doi: 10.1097/CCM.0b013e31819cefa9.
PubMed 19242333Khemani RG, Patel NR, Bart RD 3rd, Newth CJL. Comparison of the pulse oximetric saturation/fraction of inspired oxygen ratio and the PaO2/fraction of inspired oxygen ratio in children. Chest. 2009 Mar;135(3):662-668. doi: 10.1378/chest.08-2239. Epub 2008 Nov 24.
PubMed 19029434Khemani RG, Thomas NJ, Venkatachalam V, Scimeme JP, Berutti T, Schneider JB, Ross PA, Willson DF, Hall MW, Newth CJ; Pediatric Acute Lung Injury and Sepsis Network Investigators (PALISI). Comparison of SpO2 to PaO2 based markers of lung disease severity for children with acute lung injury. Crit Care Med. 2012 Apr;40(4):1309-16. doi: 10.1097/CCM.0b013e31823bc61b.
PubMed 22202709Thomas NJ, Shaffer ML, Willson DF, Shih MC, Curley MA. Defining acute lung disease in children with the oxygenation saturation index. Pediatr Crit Care Med. 2010 Jan;11(1):12-7. doi: 10.1097/PCC.0b013e3181b0653d.
PubMed 19561556Lobete C, Medina A, Rey C, Mayordomo-Colunga J, Concha A, Menendez S. Correlation of oxygen saturation as measured by pulse oximetry/fraction of inspired oxygen ratio with Pao2/fraction of inspired oxygen ratio in a heterogeneous sample of critically ill children. J Crit Care. 2013 Aug;28(4):538.e1-7. doi: 10.1016/j.jcrc.2012.12.006. Epub 2013 Feb 8.
PubMed 23395312Ellis RK. Determination of PO2 from saturation. J Appl Physiol (1985). 1989 Aug;67(2):902. doi: 10.1152/jappl.1989.67.2.902. No abstract available.
PubMed 2793692Severinghaus JW. Simple, accurate equations for human blood O2 dissociation computations. J Appl Physiol Respir Environ Exerc Physiol. 1979 Mar;46(3):599-602. doi: 10.1152/jappl.1979.46.3.599.
PubMed 35496Lanspa MJ, Jones BE, Brown SM, Dean NC. Mortality, morbidity, and disease severity of patients with aspiration pneumonia. J Hosp Med. 2013 Feb;8(2):83-90. doi: 10.1002/jhm.1996. Epub 2012 Nov 26.
PubMed 23184866Dean NC, Jones JP, Aronsky D, Brown S, Vines CG, Jones BE, Allen T. Hospital admission decision for patients with community-acquired pneumonia: variability among physicians in an emergency department. Ann Emerg Med. 2012 Jan;59(1):35-41. doi: 10.1016/j.annemergmed.2011.07.032. Epub 2011 Sep 9.
PubMed 21907451Brown SM, Jones BE, Jephson AR, Dean NC; Infectious Disease Society of America/American Thoracic Society 2007. Validation of the Infectious Disease Society of America/American Thoracic Society 2007 guidelines for severe community-acquired pneumonia. Crit Care Med. 2009 Dec;37(12):3010-6. doi: 10.1097/CCM.0b013e3181b030d9.
PubMed 19789456Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004.
PubMed 15791098
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imputation of PaO2 From SaO2 in the Respiratory Component of the Sequential Organ Failure Assessment (SOFA) Score
- ClinicalTrials.gov ID
- NCT02598492
- Acronym / sponsor ID
- 2015P001945
- Conditions
- Acute Respiratory Failure
- Keywords
- Mechanical Ventilator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Guangzhou Red Cross Hospital, Guangdong Provincial People's Hospital
- Study start
- 1 Sep 2015
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Nov 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.
The aims of this study are (1) to find out the relationship between PaO2 and SaO2 among mechanically ventilated patients and (2) to create a reliable system to utilize SF ratios to impute the PF ratios in assessing the respiratory parameter of the SOFA score.
Detailed description
The Sequential Organ Failure Assessment (SOFA) score is validated as a measure of severity of illness over time in intensive care unit (ICU) patients and can be used to follow the course of organ dysfunction and response to treatment1. SOFA has become a frequently used scoring system of patients in multi-organ failure, given its high sensitivity and specificity as a predictor of morbidity and mortality in critically ill patients2. The severity of respiratory dysfunction is measured in the SOFA score by PaO2/FiO2 (PF) ratio, which is also used as a measure of severity of hypoxemia in patients with acute respiratory distress syndrome (ARDS).
An invasive sampling of arterial blood gas (ABG) is required to measure the PaO2 for the PF. Often, patients with less severe hypoxemia may not clinically undergo ABG testing on a routine basis; hence the clinical and research utility of the SOFA scoring system is reduced. Furthermore, previous studies revealed concerns about anemia following repeated blood sampling; hence, the tendency to implement less invasive approaches have led to less frequent ABG measurements in critically ill patients3. However, almost all ICU patients are monitored with pulse oximeters, which measure the percent saturation of hemoglobin with oxygen (SpO2). Whether SpO2 can be used to impute PaO2 for determining the PF ratio has not been robustly evaluated in a prospective study of critically ill patients.
Prior work investigating the association between PaO2 and SpO2 includes a post hoc study of ARDS Network patients4. This study excluded patients at altitude, used a linear model for a highly non-linear relationship, and could not determine whether SpO2 and PaO2 were simultaneously measured. A similar approach was applied to ARDS Network patients to derive an SpO2-based respiratory subscore of the SOFA score5. Several similar, retrospective studies have been performed in mechanically ventilated children, consistently using linear models of correlation between SF and PF ratios, with similar limitations6-9.
The Ellis inversion10 of the Severinghaus equation11 provides a useful non-linear method for imputing PaO2 from SaO2. This technique has been used in multiple cohorts of patients with pneumonia12-14. This simple calculation can be improved by incorporating PaCO2 and pH values, which could be available from venous blood gases that may be obtained in patients without arterial catheters. Because Severinghaus/Ellis estimates SaO2, a method for estimating SaO2 from SpO2 is necessary. There is no current validated and reliable method for calculating SaO2 on the basis of a measured SpO2. Skin pigmentation affects accuracy of SpO2, as do sex and oximeter type15,16.
The aims of this study are (1) to find out the relationship between PaO2 and SaO2 among mechanically ventilated patients and (2) to create a reliable system to utilize SF ratios to impute the PF ratios in assessing the respiratory parameter of the SOFA score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imputation of SF to PF | – | Other: arterial blood gasPatients required invasive mechanical ventilation within 6 hours after intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults > 18 years old who are invasively mechanically ventilated in an ED or ICU
Key inclusion criteria (2 listed)
- Mechanically ventilated patient in a participating ICU or ED.
- Arterial blood gas ordered and obtained for clinical reasons.
Key exclusion criteria (3 listed)
- Age < 18 years
- Pregnancy
- Prisoners
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 |
|---|---|---|
| arterial blood gasAlso: oxygena saturationJust record clinical lab data | Other | Imputation of SF to PF |
Primary outcome
To evaluate the relationship between PaO2 and SaO2 among mechanically ventilated patients
Time frame: one year
1 secondary outcome
To utilize SF ratios to impute the PF ratios in assessing the respiratory parameter of the SOFA score
Time frame: one year
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 8 Mar 2022.
- Results publication: PubMed 9824069Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
- Results publication: PubMed 10768086Vincent JL, Ferreira F, Moreno R. Scoring systems for assessing organ dysfunction and survival. Crit Care Clin. 2000 Apr;16(2):353-66. doi: 10.1016/s0749-0704(05)70114-7.
- Results publication: PubMed 16215375Ferguson ND, Frutos-Vivar F, Esteban A, Fernandez-Segoviano P, Aramburu JA, Najera L, Stewart TE. Acute respiratory distress syndrome: underrecognition by clinicians and diagnostic accuracy of three clinical definitions. Crit Care Med. 2005 Oct;33(10):2228-34. doi: 10.1097/01.ccm.0000181529.08630.49.
- Results publication: PubMed 17573487Rice TW, Wheeler AP, Bernard GR, Hayden DL, Schoenfeld DA, Ware LB; National Institutes of Health, National Heart, Lung, and Blood Institute ARDS Network. Comparison of the SpO2/FIO2 ratio and the PaO2/FIO2 ratio in patients with acute lung injury or ARDS. Chest. 2007 Aug;132(2):410-7. doi: 10.1378/chest.07-0617. Epub 2007 Jun 15.
- Results publication: PubMed 19242333Pandharipande PP, Shintani AK, Hagerman HE, St Jacques PJ, Rice TW, Sanders NW, Ware LB, Bernard GR, Ely EW. Derivation and validation of Spo2/Fio2 ratio to impute for Pao2/Fio2 ratio in the respiratory component of the Sequential Organ Failure Assessment score. Crit Care Med. 2009 Apr;37(4):1317-21. doi: 10.1097/CCM.0b013e31819cefa9.
- Results publication: PubMed 19029434Khemani RG, Patel NR, Bart RD 3rd, Newth CJL. Comparison of the pulse oximetric saturation/fraction of inspired oxygen ratio and the PaO2/fraction of inspired oxygen ratio in children. Chest. 2009 Mar;135(3):662-668. doi: 10.1378/chest.08-2239. Epub 2008 Nov 24.
- Results publication: PubMed 22202709Khemani RG, Thomas NJ, Venkatachalam V, Scimeme JP, Berutti T, Schneider JB, Ross PA, Willson DF, Hall MW, Newth CJ; Pediatric Acute Lung Injury and Sepsis Network Investigators (PALISI). Comparison of SpO2 to PaO2 based markers of lung disease severity for children with acute lung injury. Crit Care Med. 2012 Apr;40(4):1309-16. doi: 10.1097/CCM.0b013e31823bc61b.
- Results publication: PubMed 19561556Thomas NJ, Shaffer ML, Willson DF, Shih MC, Curley MA. Defining acute lung disease in children with the oxygenation saturation index. Pediatr Crit Care Med. 2010 Jan;11(1):12-7. doi: 10.1097/PCC.0b013e3181b0653d.
- Results publication: PubMed 23395312Lobete C, Medina A, Rey C, Mayordomo-Colunga J, Concha A, Menendez S. Correlation of oxygen saturation as measured by pulse oximetry/fraction of inspired oxygen ratio with Pao2/fraction of inspired oxygen ratio in a heterogeneous sample of critically ill children. J Crit Care. 2013 Aug;28(4):538.e1-7. doi: 10.1016/j.jcrc.2012.12.006. Epub 2013 Feb 8.
- Results publication: PubMed 2793692Ellis RK. Determination of PO2 from saturation. J Appl Physiol (1985). 1989 Aug;67(2):902. doi: 10.1152/jappl.1989.67.2.902. No abstract available.
- Results publication: PubMed 35496Severinghaus JW. Simple, accurate equations for human blood O2 dissociation computations. J Appl Physiol Respir Environ Exerc Physiol. 1979 Mar;46(3):599-602. doi: 10.1152/jappl.1979.46.3.599.
- Results publication: PubMed 23184866Lanspa MJ, Jones BE, Brown SM, Dean NC. Mortality, morbidity, and disease severity of patients with aspiration pneumonia. J Hosp Med. 2013 Feb;8(2):83-90. doi: 10.1002/jhm.1996. Epub 2012 Nov 26.
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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.
Peter C Hou, MD principal investigator
Brigham and Women's Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Brigham and Women's Hospital at 3 sites in 2 countries.
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 2 inclusion and 3 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, United States. 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?
To evaluate the relationship between PaO2 and SaO2 among mechanically ventilated patients (time frame: one year). 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 NCT02598492, which also lists 18 linked publications.
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 8 Mar 2022.