Imputation of PaO2 From SaO2

NCT02598492 | Completed DMC

• 1 other identifier: 2015P001945
• Study Type: observational
• Target: 646
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Acute Respiratory Failure

Keywords

Mechanical Ventilator

Outcome Measures

Primary Outcomes (1)

• To evaluate the relationship between PaO2 and SaO2 among mechanically ventilated patients

  one year

Secondary Outcomes (1)

• To utilize SF ratios to impute the PF ratios in assessing the respiratory parameter of the SOFA score

  one year

Study Arms (1)

Imputation of SF to PF

Patients required invasive mechanical ventilation within 6 hours after intubation

Other: arterial blood gas

Interventions

arterial blood gas OTHER

Just record clinical lab data

Also known as: oxygena saturation

Imputation of SF to PF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults \> 18 years old who are invasively mechanically ventilated in an ED or ICU

You may qualify if:

• Mechanically ventilated patient in a participating ICU or ED.
• Arterial blood gas ordered and obtained for clinical reasons.

You may not qualify if:

• Age \< 18 years
• Pregnancy
• Prisoners

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Chinese PLA General Hospital: collaborator
• Guangzhou Red Cross Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Guangzhou Red Cross Hospital

Guangzhou, Guangdong, China

Location

PLA General Hospital

Beijing, China

Location

Related Publications (18)

• 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.

  PMID: 9824069 RESULT

• Vincent 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.

  PMID: 10768086 RESULT

• Ferguson 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.

  PMID: 16215375 RESULT

• Rice 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.

  PMID: 17573487 RESULT

• Pandharipande 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.

  PMID: 19242333 RESULT

• Khemani 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.

  PMID: 19029434 RESULT

• Khemani 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.

  PMID: 22202709 RESULT

• Thomas 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.

  PMID: 19561556 RESULT

• Lobete 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.

  PMID: 23395312 RESULT

• Ellis 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.

  PMID: 2793692 RESULT

• Severinghaus 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.

  PMID: 35496 RESULT

• Lanspa 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.

  PMID: 23184866 RESULT

• Dean 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.

  PMID: 21907451 RESULT

• Brown 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.

  PMID: 19789456 RESULT

• Bickler 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.

  PMID: 15791098 RESULT

• Feiner JR, Severinghaus JW, Bickler PE. Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender. Anesth Analg. 2007 Dec;105(6 Suppl):S18-S23. doi: 10.1213/01.ane.0000285988.35174.d9.

  PMID: 18048893 RESULT

• Utada K, Matayoshi Y, Fujita F, Nakamura K, Matsuda N, Kondoh K, Tamura H. [Equilibration period for PaO2 following alteration of FIO2 in mechanically ventilated patients]. Masui. 2000 Mar;49(3):312-5. Japanese.

  PMID: 10752330 RESULT

• Fildissis G, Katostaras T, Moles A, Katsaros A, Myrianthefs P, Brokalaki H, Tsoumakas K, Baltopoulos G. Oxygenation equilibration time after alteration of inspired oxygen in critically ill patients. Heart Lung. 2010 Mar-Apr;39(2):147-52. doi: 10.1016/j.hrtlng.2009.06.009. Epub 2009 Aug 13.

  PMID: 20207275 RESULT

MeSH Terms

Interventions

Blood Gas Analysis

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Peter C Hou, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: September 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

CN (2); US (1)