CClinicalTrials.gg
Status unknownNCT02701725CRIHEMUpdated Mar 9, 2016

Compensatory Reserve Index as a Hemodynamic Status Evaluation Tool in Patients

An observational study in Hemorrhage and Sepsis, sponsored by Meir Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-09.

Sponsored by Meir Medical Center · Observational

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study summary

The investigators will use the Compensatory Reserve Index (CRI) device to monitor hemodynamic status of patients in the hospital. CRI values of patients will be monitored during their care in order to verify the compliance of the values to the physiological condition. During the protocol investigators will document patients injuries, life-saving procedures performed, response to treatment as well progress to systemic inflammatory response syndrome (SIRS) and sepsis.

The indices measured in the study will not be a consideration when handling patients. The medical team will not be exposed to metrics measured.

Read the detailed description

Assessment of patients in the emergency department, ICU or surgical department can be a challenging process. This assessment includes collecting data regarding injury mechanism, vital signs, and physical examination findings before proceeding to other ways of evaluating the patient.

These data are then integrated in an attempt to form an accurate patient status and to determine the urgency of treatment and evacuation to the next echelon of care when necessary. When caring for multiple casualties, this process takes on an even greater importance because the care of one patient can delay the care of others.

Triage and monitoring of patients consists of several vital sign measurements including blood pressure, oxygen saturation, and heart rate. These measurements show varying correlation with patient survival, Injury Severity Score, and the need for life-saving intervention. The most significant disadvantage of their use as part of patient triage is that they are all retrospective by nature, and a change in these indices occur only after substantial hemodynamic compromise and failure of compensatory mechanisms when life-saving interventions might be too late.

Because of the limitations inherent to these vital signs, several calculated indices have been suggested in an attempt to integrate a few vital signs into more sensitive metrics for prediction of patient outcomes. The most frequently described metric is shock index (SI), which is calculated as the ratio between heart rate and systolic blood pressure (normal values, 0.5 Y 0.7), and has demonstrated superiority over other indices. Heart rate variability has also been frequently suggested as a calculated vital sign, but its clinical utility in the acute blood loss setting has proven to be limited as a result of its high interpatient and intrapatient variability.

The Compensatory Reserve Index (CRI) represents a new paradigm for measuring the physiological reserve of integrated cardiopulmonary mechanisms (e.g., tachycardia, vasoconstriction, breathing) that compensate for reduced central blood volume. Advanced sensor technologies such as photoplethysmography enable noninvasive recordings of analog arterial waveforms. Using a model that induces stepwise reduction of central blood volume (lower body negative pressure [LBNP]) in volunteering young healthy human test subjects, through application of negative pressure to the lower body, feature-extraction and machine-learning techniques were used to reveal subtle changes in waveform features that are associated with a declining volume. This approach enables simultaneous abstraction and normalization of various characteristics of the arterial waveform. As such, the CRI aims to reflect the capacity of all factors contributing to physiological compensatory mechanisms, including compensatory reflexes, various muscle contractions, and respirations, among others. Compensatory Reserve Index values range from 0 (complete decompensation) to 1 (full compensatory reserve available). The device itself is compact, light, and can be placed on the patient's finger, and the test can be performed within 30 s, making the measurement of CRI theoretically feasible in almost any setting. The approach was designed to prospectively identify ongoing loss of central blood volume and thus estimate the point at which individuals will experience hemodynamic decompensation (onset of shock) well in advance compared with changes in standard or "legacy" vital signs.

The CRI has been shown to correlate with central blood volume changes in human subjects in laboratory conditions however, few published data regarding its use in other experimental models or its ability to detect actual blood loss exist. The current investigation represents the first effort to apply a small pulse oximeter unit to test the CRI on human subjects admitted to hospital.

The purpose of the study is to test the hypothesis that a novel noninvasive CRI monitoring algorithm would demonstrate greater sensitivity and specificity compared with standard vital signs for identifying patients with blood loss, SIRS, sepsis thus enabling appropriate measures to be taken.

02

Conditions studied

  • Hemorrhage
  • Sepsis

Browse trials for

03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 600 is above the median of 150 across 893 observational studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A prospective Review of all adult patients admitted to Meir Medical Center who meet criteria.

Inclusion criteria

  • All patients with blood loss (trauma or disease)
  • All patients receiving blood products of any type
  • All patients with SIRS or Sepsis
  • All patients who are anticipated to suffer for sepsis

Exclusion criteria

Exclusion Criteria:

  • Under 18 years old
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Interventions

  • DeviceCRI status

    Measurement of CRI

06

What researchers measure

Primary outcomes

  1. change in CRI

    Time frame: 6 m

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • King DR, Ogilvie MP, Pereira BM, Chang Y, Manning RJ, Conner JA, Schulman CI, McKenney MG, Proctor KG. Heart rate variability as a triage tool in patients with trauma during prehospital helicopter transport. J Trauma. 2009 Sep;67(3):436-40. doi: 10.1097/TA.0b013e3181ad67de. PubMed 19741382 ↗
  • Convertino VA, Ryan KL, Rickards CA, Salinas J, McManus JG, Cooke WH, Holcomb JB. Physiological and medical monitoring for en route care of combat casualties. J Trauma. 2008 Apr;64(4 Suppl):S342-53. doi: 10.1097/TA.0b013e31816c82f4. PubMed 18385586 ↗
  • Soller BR, Zou F, Ryan KL, Rickards CA, Ward K, Convertino VA. Lightweight noninvasive trauma monitor for early indication of central hypovolemia and tissue acidosis: a review. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S106-11. doi: 10.1097/TA.0b013e318260a928. PubMed 22847078 ↗
  • Bruijns SR, Guly HR, Bouamra O, Lecky F, Lee WA. The value of traditional vital signs, shock index, and age-based markers in predicting trauma mortality. J Trauma Acute Care Surg. 2013 Jun;74(6):1432-7. doi: 10.1097/TA.0b013e31829246c7. PubMed 23694869 ↗
  • Moulton SL, Mulligan J, Grudic GZ, Convertino VA. Running on empty? The compensatory reserve index. J Trauma Acute Care Surg. 2013 Dec;75(6):1053-9. doi: 10.1097/TA.0b013e3182aa811a. PubMed 24256681 ↗
  • Birkhahn RH, Gaeta TJ, Terry D, Bove JJ, Tloczkowski J. Shock index in diagnosing early acute hypovolemia. Am J Emerg Med. 2005 May;23(3):323-6. doi: 10.1016/j.ajem.2005.02.029. PubMed 15915406 ↗
  • Rixen D, Siegel JH, Friedman HP. "Sepsis/SIRS," physiologic classification, severity stratification, relation to cytokine elaboration and outcome prediction in posttrauma critical illness. J Trauma. 1996 Oct;41(4):581-98. doi: 10.1097/00005373-199610000-00001. PubMed 8858015 ↗
  • Convertino VA, Howard JT, Hinojosa-Laborde C, Cardin S, Batchelder P, Mulligan J, Grudic GZ, Moulton SL, MacLeod DB. Individual-Specific, Beat-to-beat Trending of Significant Human Blood Loss: The Compensatory Reserve. Shock. 2015 Aug;44 Suppl 1:27-32. doi: 10.1097/SHK.0000000000000323. PubMed 25565640 ↗
  • Nadler R, Convertino VA, Gendler S, Lending G, Lipsky AM, Cardin S, Lowenthal A, Glassberg E. The value of noninvasive measurement of the compensatory reserve index in monitoring and triage of patients experiencing minimal blood loss. Shock. 2014 Aug;42(2):93-8. doi: 10.1097/SHK.0000000000000178. PubMed 24667628 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02701725
Lead sponsor
Meir Medical Center
Responsible party
Sponsor
First posted
Mar 8, 2016
Start date
Mar 2016
Primary completion
May 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Mar 9, 2016

Study contacts

Avi Benov, M.D M.H.A
Contact
avi.benov@clalit.org.il
97297472501

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion