Anesthesia Charting Fidelity Study

NCT01179932 | Withdrawn

• 1 other identifier: Charting Pilot
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: Conduct a prospective, observational pilot study that assesses the frequency and severity of anesthesia charting fidelity weaknesses in three separate clinical environments (Cardiac surgical operating room, cardiac surgical intensive care unit, and electrophysiology laboratory) as assessed by a customized error scoring system that focuses on the magnitude of errors among multiple continuous, categorical and dichotomous variables. The errors are being assessed in order to identify the most common charting inaccuracies so that target areas appropriate for testing of improvement strategies may be isolated.

Conditions

Anesthesia

Keywords

Pilot; Charting; Anesthesia Record; Cardiac surgical operating room; Cardiac surgical intensive care unit; Electrophysiology lab

Outcome Measures

Primary Outcomes (1)

• Frequency/severity of anesthesia charting fidelity weaknesses in cardiac care based clinical environments as assessed by an error scoring system.

  A single dedicated observer with focused clinical education will continually scribe observations made with close attention to detail (e.g., time of event, drug administered, dose of drug, route of administration of drug) using a prospectively designed data collection tool. This record of events will then be compared to the clinician charted anesthesia record in order to assess the frequency and severity of errors ocurring within the anesthesia record. A customized scoring system will be employed to grade the observed errors noted in the anesthesia record.

  A total of thirty separate anesthesia records will be inidividually assessed and compared to the data prospectively collected during each corresponding anesthetic (lasting an average of 5 hours in the OR and 45 min in the EP lab.

Study Arms (1)

Anesthesia Record

The nursing and anesthesia records will be examined for accuracy and completeness

Other: No Intervention Used

Interventions

No Intervention Used OTHER

Our study is observational; therefore, there is no type of intervention being used.

Anesthesia Record

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

Deidentified patients undergoing a cardiac surgical procedure or undergoing select electrophysiologic procedures as well as the corresponding clinical staff caring for them.

You may qualify if:

• Male or female patients ≥ 18 years of age
• Patients and the hospital staff that are caring for them, scheduled to undergo any cardiac surgical procedure that involves the use of both general anesthesia (with planned computer assisted charting using the PISCES system) and cardiopulmonary bypass, including postoperative intensive care unit monitoring -or- Patients and the hospital staff caring for them scheduled to undergo select electrophysiologic procedures (detailed below 1 - 3) involving the administration of general anesthesia in the electrophysiology laboratory with planned manual paper charting
• Defibrillation threshold testing using non-invasive programmed stimulation of an implantable cardiovertor defibrillator (ICD)
• Transesophageal echocardiography guided electrical cardioversion of patients with supraventricular arrhythmias
• Electrical cardioversion of patients with supraventricular arrhythmias

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (5)

• Chamisa I, Zulu BM. Setting the records straight--a prospective audit of the quality of case notes in a surgical department. S Afr J Surg. 2007 Aug;45(3):92, 94-5.

  PMID: 17892187 RESULT

• Ho MY, Anderson AR, Nijjar A, Thomas C, Goenka A, Hossain J, Curley PJ. Use of the CRABEL Score for improving surgical case-note quality. Ann R Coll Surg Engl. 2005 Nov;87(6):454-7. doi: 10.1308/003588405X60687.

  PMID: 16263017 RESULT

• Devitt JH, Rapanos T, Kurrek M, Cohen MM, Shaw M. The anesthetic record: accuracy and completeness. Can J Anaesth. 1999 Feb;46(2):122-8. doi: 10.1007/BF03012545.

  PMID: 10083991 RESULT

• Byrne AJ, Sellen AJ, Jones JG. Errors on anaesthetic record charts as a measure of anaesthetic performance during simulated critical incidents. Br J Anaesth. 1998 Jan;80(1):58-62. doi: 10.1093/bja/80.1.58.

  PMID: 9505779 RESULT

• Byrne AJ, Jones JG. Inaccurate reporting of simulated critical anaesthetic incidents. Br J Anaesth. 1997 Jun;78(6):637-41. doi: 10.1093/bja/78.6.637.

  PMID: 9215012 RESULT

Study Officials

• Edwin G Avery, MD

  UH Case Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: August 11, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2011
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

US (1)