Draft

142  Ctsi Translational Research Trainee Symposium Talk

142.1 Summary

  • Improved Recognition of Inpatient Hypercapnic Respiratory Failure
  • Hypercapnic Respiratory Failure
  • E.g.: Home PAP improves mortality in ↑CO2-COPD
  • By the time patients are caught: ↑morbidity
  • OVERALL: There is an important burden of unrecognized hypercapnia among hospitalized patients.
  • Aim 1: To determine the local accuracy of non-invasive assessments of blood PaCO2
  • Aim 2: To estimate the prevalence of unrecognized hypercapnia in inpatients
  • Aim 3: To estimate the potential impact of early & reliable identification
  • Additional Design Thoughts:

142.2 Slide outline

142.2.1 Slide 1

  • Improved Recognition of Inpatient Hypercapnic Respiratory Failure
  • Brian Locke, MD
  • T32 Fellow
  • Division of Pulmonary, Critical Care, and Occupational Pulmonary Medicine
  • Department of Internal Medicine
  • University of Utah School of Medicine
  • This research was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award 5T32HL105321 from the NIH
  • and The American Thoracic Society through the Academic Sleep and Pulmonary Integrated Research/Clinical Fellowship (ASPIRE) Program ### Slide 2
  • Hypercapnic Respiratory Failure
  • Hypoxemic (Low O2) Respiratory Failure
  • Hypercapnic (High CO2) Respiratory Failure
  • Low arterial blood oxygen tension
  • High arterial blood carbon dioxide tension
  • (Relatively) Reliably Identified by Pulse Oximetry
  • No routine non-invasive testing
  • Build up here CO2 in blood rises
  • “What gets measured gets managed”
  • Patients with hypercapnia are identified unreliably and late in their illness ### Slide 3
  • E.g.: Home PAP improves mortality in ↑CO2-COPD
  • Weight loss
  • Medication Adjustment
  • Pulmonary Rehab
  • Hypercapnia is common, is probably becoming more common, and is treatable.
  • Common contributors to Hypercapnic Respiratory Failure:
  • Advanced Age
  • Opiate Use
  • Obesity
  • Advanced Lung Dz
  • Multimorbidity
  • Population-standardized prevalence PaCO2 > 45 mmHg after excluding iatrogenic causes:
  • 150 per 100,000 person/year
  • Only inpatients, only those with blood gasses checked
  • Comparison: Decompensated Cirrhosis 94.9 (US, 2017) per 100,000 person year ### Slide 4
  • By the time patients are caught: ↑morbidity
  • Inpatient ICD code for Hypercapnic Respiratory Failure
  • 23% 30d readmission rate
  • Same as CHF, more than MI
  • 66% with recurrence
  • Could we catch them earlier? Would it help?
  • Lung Adenocarcinoma, for reference ### Slide 5
  • OVERALL: There is an important burden of unrecognized hypercapnia among hospitalized patients.
  • OVERALL: There is a significant burden of unrecognized hypercapnia among hospitalized patients.
  • 3 aims
  • Aim 1: Non-invasive Validation
  • Aim 2: Prevalence Estimate
  • Aim 3: Potential Impact
  • Hypothesis
  • Less invasive methods of blood CO2 assessment (TcCO2) Risk Stratification) can identify hypercapnia with sufficient accuracy to estimate prevalence.
  • There is a sizable prevalence of unrecognized hypercapnia among hospitalized patients.
  • Inpatients who were predicted, but not confirmed, to have hypercapnic respiratory failure are at comparable risk of readmission to those identified.
  • Barrier
  • TcCO2 and bicarbonate+ are perceived as problematic for individual patient use.
  • ABGs a selectively and unreliably obtained in clinical practice, and cannot be indiscriminately obtained for research
  • Prior work showing high readmission rates only assess patients who have been identified as hypercapnic.
  • Insight
  • Scatter, without bias, can allow accurate estimation of prevalence
  • Risk modeling allows for stratified sampling better efficiency.
  • ABG PaCO2 is an imperfect reference standard
  • Approach
  • Obtain paired samples with ordered ABGs (inpatient).
  • Non-invasively sample (with TcCO2) patients by strata of predicted hypercapnia risk.
  • Among patients with an admission for hypercapnia that is identified, how many had preceding admissions likely to have hypercapnia? ### Slide 6
  • Aim 1: To determine the local accuracy of non-invasive assessments of blood PaCO2
  • Tool
  • Health Record-Based Modeling
  • Transcutaneous CO2
  • Purpose
  • Refine Estimation of Pre-test Odds of Hypercapnia
  • Allow non-invasive CO2 assessment (patients unlikely to consent for research ABGs)
  • Limitation
  • Approach only externally validated in outpatient OHS assessment
  • Prior 95% agreement +/- 6 mmHg insufficient for unstratified clinical use
  • Total
  • No ABG Obtained
  • ABG Obtained
  • N879,019
  • N675,620
  • N203,399
  • Ambulatory
  • 39% (343,699)
  • 50% (334,457)
  • 5% (9,242)
  • Emergency
  • 20% (175,792)
  • 22% (146,066)
  • 15% (29,726)
  • Inpatient
  • 41% (359,528)
  • 29% (195,097)
  • 81% (164,431) ### Slide 7
  • Aim 1: To determine the local accuracy of non-invasive assessments of blood PaCO2
  • N~65 power of 0.8 for TcCO2-PaCO2 LOA ~8mmHg
  • Expected Outcomes:
  • TcCO2 feasibility assessment
  • TcCO2 local limits of agreement
  • Predictive modeling external validation
  • Career development aim: prospective study design and execution ### Slide 8
  • Aim 2: To estimate the prevalence of unrecognized hypercapnia in inpatients
  • Statistical Insights:
  • Accuracy needed for clinical care ≠ Required accuracy for prevalence estimate
  • Pre-test probability estimate allows stratified sampling → efficiency
  • 49: Correct 93%, Wrong 7%: weight: 1.98%
  • 48: Correct 88%, Wrong 12%: weight: 2.39%
  • 47: Correct 80%, Wrong 20%: weight: 2.47%
  • 46: Correct 69%, Wrong 31%: weight: 2.92%
  • 45: Correct 57%, Wrong 43%: weight: 3.11%
  • SENSITIVITY
  • SPECIFICITY
  • 44: Correct 57%, Wrong 43% 3.56%
  • 43: Correct 69%, Wrong 31% weight 3.73
  • 42: Correct 80%, Wrong 20% weight 4.16%
  • 41: Correct 88%, Wrong 12% weight 4.25%
  • 40: Correct 93%, Wrong 7% weight 4.58%
  • ….
  • Expected test characteristics:
  • sensitivity 89%
  • specificity 92%
  • if
  • agreement ~6 mmHg
  • same distribution of CO2 ### Slide 9
  • Aim 2: To estimate the prevalence of unrecognized hypercapnia in inpatients
  • Design:
  • Within 24 hours of admit
  • Stratified sampling by decile of the predicted likelihood of hypercapnia
  • Overall prevalence estimate weighted [by overall hospital] average of decile prevalences.
  • Apply TcCO2
  • Sample Size Calculation:
  • Complex: Upper bound unstratified: n200 would give 5% 95CI width at expected prevalence of 2.5%
  • Outcomes:
  • Estimated in-hospital prevalence
  • % recognized(?) – should information be shared with teams? (or, vs historical control)
  • How will this fail?
  • Several pieces of data will update power calc
  • (distribution of predicted hypercapnia deciles, bias/agreement of TcCO2)
  • Can I access EHR data fast enough?
  • Hawthorne effect?
  • What if TcCO2 isn’t good enough? (VBG?)
  • Elevation adjustment? Due to hypoxemia, do they get identified earlier?
  • Nowbar et al. 2004: All w/ BMI ≥35 kg/m2 admitted to inpatient medicine service at the Denver VA. Everyone (n277) gets an ABG. 31% had hypercapnia. Only 1/3 of those had therapy started (teams were told) ### Slide 10
  • Aim 3: To estimate the potential impact of early & reliable identification
  • More aggressive case identification could lead to underwhelming improvements in important outcomes if:
  • Clinicians already identify the important cases
  • Or, if earlier identification doesn’t actually facilitate helpful treatment
  • Perhaps, nothing bad would have happened in the period between identifications
  • Or, nothing could be done to change that trajectory
  • Rigor of the supporting research:
  • Marik et al. 2013: patient diagnosed with OHS are repeatedly admitted and missed diagnosed prior to their ultimate recognition
  • Single center with non-representative enrollment (only obese patients)
  • Meservey et al 2020. and Vonderbank et al 2021: readmission rates are high after diagnosis (~1/3 of patients) - likely because the pipeline from identification to treatment is very unreliable.
  • This only studies patients who are identified as hypercapnic
  • Cavalot et al 2022: across etiologies (enrolled in an emergency department), patients with hypercapnia (by ABG) have worse outcomes than patients without
  • Not matched for other prognostic indicators ### Slide 11
  • Aim 3: To estimate the potential impact of early & reliable identification
  • Hypothesis: Patients predicted to have had hypercapnia that was not recognized have a similar or excess risk of subsequent readmission as those identified (by blood gas and/or ICD code)
  • Study Design:
  • Retrospective EHR-based review
  • Dataset: Longitudinal, ideal self-contained system
  • Exposures of interest:
  • Hypercapnic Respiratory Failure by ICD code
  • Hypercapnic Respiratory Failure by ABG (or by VBG) & not ICD code
  • Predicted Risk of Hypercapnic Respiratory Failure by commonly obtained data-elements
  • Effect modifier: PAP/NIV therapy
  • Outcome: Hazard of death or rehospitalization with hypercapnia
  • Those who likely had hypercapnia, but were not sampled
  • Model predicted to have hypercapnia
  • Comparison in consequences ### Slide 12
  • Additional Design Thoughts:
  • Data requirements: need to be able to accurately obtain relevant data elements for prediction model (if they were obtained by providers)
  • Musts: Demographics, labs (BMP), ABG & VBG data, Diagnostic Codes, Admissions, Deaths
  • Ideal? PAP and oxygen prescriptions
  • Possible Designs
  • Single arm
  • Case-Control
  • Matched Cohort
  • Inclusion: 1st identified hypercapnic respiratory failure admission
  • Case: 1st identified Hypercap-RF
  • Control: matched hypox RF?
  • Exposure: %Predicted likelihood of hypercapnia [including 100% when confirmed]
  • 143 and rate of preceding likely-hypercap admissions

  • OR of a prior “likely to have hypercapnia” encounter
  • HR of readmission or death, modeled with restricted cubic spline [or categories] ### Slide 13
  • Additional Design Thoughts:
  • Threats to validity:
  • Would be difficult to show it’s the predicted hypercapnia risk that raises risk, per-se (rather than things associated with it… negative control outcomes?)
  • Risk of readmission may be lower when hypercapnia is identified and proper treatment is instituted (which will be hard to determine from either ICD codes or procedure codes, I think)
  • Risk among patients with hypercapnia is not binary [ie risk PaCO290 >>> 50] ### Slide 14
  • What is expected to come from this research?
  • Validation of a method of stratification that can be used to:
  • Facilitate the identification of patients with high CO2 → improved patient care
  • Identify patients with hypercapnia (± a verification method) for study inclusion → more representative cohorts of patients.
  • Enable future studies assessing:
  • Overall burden of disease from hypercapnic respiratory failure
  • Effect of exposures (medications, environmental, policy) on risk of hypercapnia
  • Test the effect of treatment interventions on broader types of high-risk patients.
  • Career-development:
  • Development of models (statistical, ML, etc.) exploding in healthcare
  • a dearth of validated uses → investigators with experience in prospective model application and validation needed

143.1 Learning objectives

  • Improved Recognition of Inpatient Hypercapnic Respiratory Failure
  • Hypercapnic Respiratory Failure
  • E.g.: Home PAP improves mortality in ↑CO2-COPD
  • By the time patients are caught: ↑morbidity
  • OVERALL: There is an important burden of unrecognized hypercapnia among hospitalized patients.

143.2 Bottom line / summary

  • Improved Recognition of Inpatient Hypercapnic Respiratory Failure
  • Hypercapnic Respiratory Failure
  • E.g.: Home PAP improves mortality in ↑CO2-COPD
  • By the time patients are caught: ↑morbidity
  • OVERALL: There is an important burden of unrecognized hypercapnia among hospitalized patients.

143.3 Approach

  1. TODO: Outline the initial assessment or decision point.
  2. TODO: Outline the next diagnostic or management step.
  3. TODO: Outline follow-up or escalation criteria.

143.4 Red flags / when to escalate

  • TODO: List red flags that require urgent escalation.

143.5 Common pitfalls

  • TODO: Capture common errors or missed steps.

143.6 References

TODO: Add landmark references or guideline citations.

143.7 Slides and assets

143.8 Source materials