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CompletedNCT02258100Updated Sep 11, 2019

Anesthesia Information System vs Paper Anesthesia Records for Care Congruency

An observational study in Paper Versus EMR Generated Anesthesia Records, sponsored by Endeavor Health. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-09-11.

Sponsored by Endeavor Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
189
Sex
All
01

Study summary

To date the effect of AIMS on medical interventions has not been studied. We seek to retrospectively evaluate paper and electronic anesthesia records among a single surgical population (esophageal surgery) to ascertain any differences that may exist between cohorts with regards to chart completion, anesthetic management and medical care.

Read the detailed description

Anesthesia information systems (AIMS) are increasingly used to electronically capture physiologic and management data during anesthesia. Proponents tout an improved accuracy of data yet this has not been formally evaluated. Furthermore, whether AIMS is associated with changes in medical care is unknown. Studies with newer technologies have demonstrated increased medical interventions as a result of implementation. The pulmonary artery catheter was shown to increase medical interventions when used yet no improvement in outcomes are observed and some suggest a deleterious effect. 1 Several studies suggest improved patient care with electronic anesthesia records. 2,3 These all center around clinical decision support that reminds clinicians to give certain medications or ensure chart completion. Despite these advantages there are no studies evaluating the 'hawthorne effect' of AIMS. Physiologic data is now recorded at each data point using AIMS. This differs significantly from paper anesthesia records in which clinicians often chart physiologic trends choosing to omit spurious values. It is possible that a Hawthorne effect may occur in this scenario with increased data collection and an increased ability to scrutinize the medical record. Given the litigious nature of medical practice today, there is concern about the impact of AIMS on medicolegal liability. 4 Yet, to date the effect of AIMS on medical interventions has not been studied. We seek to retrospectively evaluate paper and electronic anesthesia records among a single surgical population (esophageal surgery) to ascertain any differences that may exist between cohorts with regards to chart completion, anesthetic management and medical care.

02

Conditions studied

  • Paper Versus EMR Generated Anesthesia Records
03

In context

Lead sponsor

Endeavor Health is the lead sponsor of 110 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who underwent esophageal surgery with one surgeon from 2009-2014

Inclusion criteria

  • Underwent esophageal surgery and had anesthetic documented in medical record

Exclusion criteria

Exclusion Criteria:

  • Cases less than one hour
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
189 participants (actual)
Patient registry
No

Groups and cohorts

  • Paper

    Patients receiving care documented via paper anesthesia record.

  • AIMS

    Patients receiving care documented via electronic anesthesia record.

    Other: Electronic Medical Record

Interventions

  • OtherElectronic Medical Record

    Advent of EMR use for documentation of anesthetic care

06

What researchers measure

Primary outcomes

  1. Anesthetic Care; Drugs delivered

    Intraoperative anesthetic medications; Total dose and number of interventions for all drugs; Fentanyl, ephedrine, phenylephrine, norepinephrine, labetalol, nicardidipine, esmolol, hydrazine

    Time frame: Anesthesia start to Anesthesia Stop

  2. documented hypotension

    Intraoperative hypotension; Each occurrence less then 20% of patient's baseline, calculated from preoperative systolic BP; Duration of hypotension; associated medical treatment

    Time frame: Anesthesia start to Anesthesia End (Intraoperative)

07

Study locations

1 site
  • Evanston Hospital
    Evanston, Illinois 60201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02258100
Lead sponsor
Endeavor Health
Responsible party
Sponsor
First posted
Oct 7, 2014
Start date
Sep 2014
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Sep 11, 2019

Study contacts

Torin D Shear, MD
principal investigator · Endeavor Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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