Gas Kinetics and Metabolism in Anesthesia During Non Steady State - Full Text View

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00225381

Purpose

During clinical anesthesia, it is astonishing that CO2 monitoring consists mainly of end-tidal PCO2 to confirm endotracheal intubation and to estimate ventilation, and O2 monitoring consists of a single PO2 measurement to detect a hypoxic gas mixture. Better understanding of how O2 and CO2 kinetics monitoring can define systems pathophysiology will greatly enhance safety in anesthesia by detecting critical events such as abrupt decrease in cardiac output (Q.T) by vena-caval compression during abdominal surgery, occurrence of CO2 pulmonary embolism during laparoscopy, rising tissue O2 consumption (V.O2) during light anesthesia, and onset of anaerobic metabolism (V.CO2 is disproportionately higher than V.O2).

Condition	Intervention	Phase
Anesthetized Healthy Patients(ASA 1 or 2) in the Supine Position, Excluding Head, Neck and Head Surgeries Anesthetized Patient With Severe Systemic Disease (ASA 3 or 4)	Device: connection of measuring device to anesthesia circuit Procedure: drawing of blood sample through an arterial line, placed according to clinical criteria by primary anesthesia team Procedure: changing operating room bed position (head down and up position) Procedure: adding PEEP during anesthesia Procedure: placement of esophageal Doppler for cardiac output measurements Device: Humidity sensor Device: A mixing chamber (bymixer) Device: Pneumotachometer cuvette Device: Mass spectrometer sampling port	Phase I

MedlinePlus related topics: Anesthesia Gas

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only
Official Title:	Gas Kinetics and Metabolism in Anesthesia During Non Steady State

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

Correlation between VO2 to type of anesthesia maintenance [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]
Correlation between acid base balance and indirect calorimetry [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Detection of volatile organic compound during anaerobic metabolism [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Influence of anesthesia induction on metabolic gas exchange [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2011

Groups/Cohorts	Assigned Interventions
metabolic gas exchange and cardiac output	Device: connection of measuring device to anesthesia circuit same as name Procedure: placement of esophageal Doppler for cardiac output measurements same Device: Humidity sensor Small conventional anesthesia T piece including tiny 2 thermometer inside Device: A mixing chamber (bymixer) 2 mixing chambers (bymixers) composed of 2 arms where one arm serves as a mixing (passive) arm for the measurement of mixed gas fraction. The bymixer is made of conventional anesthesia supplies and does not influence dead space nor circuit resistance. Device: Pneumotachometer cuvette The pneumotachometer cuvette is used by many anesthesia monitors to measure gas flow.
mass spectrometer and anaerobic metabolism	Device: connection of measuring device to anesthesia circuit same as name Procedure: drawing of blood sample through an arterial line, placed according to clinical criteria by primary anesthesia team same Device: Humidity sensor Small conventional anesthesia T piece including tiny 2 thermometer inside Device: A mixing chamber (bymixer) 2 mixing chambers (bymixers) composed of 2 arms where one arm serves as a mixing (passive) arm for the measurement of mixed gas fraction. The bymixer is made of conventional anesthesia supplies and does not influence dead space nor circuit resistance. Device: Pneumotachometer cuvette The pneumotachometer cuvette is used by many anesthesia monitors to measure gas flow. Device: Mass spectrometer sampling port Designed for the anesthesia tubing and connected at the airway opening. it has small volume (3 mL) and do not influence circuit resistance.
metaboic gas exchange and type of anesthesia induction	Device: connection of measuring device to anesthesia circuit same as name Device: Humidity sensor Small conventional anesthesia T piece including tiny 2 thermometer inside Device: A mixing chamber (bymixer) 2 mixing chambers (bymixers) composed of 2 arms where one arm serves as a mixing (passive) arm for the measurement of mixed gas fraction. The bymixer is made of conventional anesthesia supplies and does not influence dead space nor circuit resistance. Device: Pneumotachometer cuvette The pneumotachometer cuvette is used by many anesthesia monitors to measure gas flow.
metabolic gas exchange and PEEP	Device: connection of measuring device to anesthesia circuit same as name Procedure: adding PEEP during anesthesia same Device: Humidity sensor Small conventional anesthesia T piece including tiny 2 thermometer inside Device: A mixing chamber (bymixer) 2 mixing chambers (bymixers) composed of 2 arms where one arm serves as a mixing (passive) arm for the measurement of mixed gas fraction. The bymixer is made of conventional anesthesia supplies and does not influence dead space nor circuit resistance. Device: Pneumotachometer cuvette The pneumotachometer cuvette is used by many anesthesia monitors to measure gas flow.
metabolic gas exchange and trendelenburg position	Device: connection of measuring device to anesthesia circuit same as name Procedure: changing operating room bed position (head down and up position) same Device: Humidity sensor Small conventional anesthesia T piece including tiny 2 thermometer inside Device: A mixing chamber (bymixer) 2 mixing chambers (bymixers) composed of 2 arms where one arm serves as a mixing (passive) arm for the measurement of mixed gas fraction. The bymixer is made of conventional anesthesia supplies and does not influence dead space nor circuit resistance. Device: Pneumotachometer cuvette The pneumotachometer cuvette is used by many anesthesia monitors to measure gas flow.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Adult patients in the supine position excluding surgeries around the head and neck area

Criteria

Inclusion Criteria:

All adult patients at UCIMC who are undergoing anesthesia and surgery are eligible for the studies.
Patients must be American Society of Anesthesiologists (ASA) Class 1 or 2 (generally healthy patients). We plan on studying 100 patients, divided into 5 equally numbered groups. A power analysis of the sample size shows the need for minimum of 20 patients. High risk 3 subgroups (ASA 3), approximately 20 adult patients (included within the 100 planned patients), will be investigated for the 1. RQ correlation with arterial blood gas, 2. for the exercise study and 3. for the esophageal Doppler studies. These study groups include patients that are categorized as ASA 1, 2 or 3, (total of 60 patients) however; the total number of ASA 3 patients will not exceed 20. Subjects having surgeries around the head and neck, as well as surgeries that require the patient to lie face down will be excluded from the study.
Gender and minority status will not be an exclusion factor for any potential study patient

Exclusion Criteria:

Cardiovascular:

Significant vascular disease, especially cardiac and cerebral vascular disease.
Patients will be excluded if they have a history of having a myocardial infarctions or cerebral vascular attack)
Significant hypertension (>170 systolic, >90 diastolic) (except for the high risk subgroup mentioned before)

Pulmonary:

Significant asthma (mild persistent or greater according to the National Asthma Education and Prevention Program classification system) chronic obstructive pulmonary disease (COPD) (Stage II: Moderate COPD according to the Global Initiative for Chronic Obstructive Lung Disease classification - Worsening airflow limitation, (FEV1≤30% ), and usually the progression of symptoms, with shortness of breath typically developing on exertion), bullous lung disease, or raised intra-cranial pressure (except for the high risk subgroup mentioned before)

Esophageal Doppler:

If localized pathology is present, including pharyngeal tumor or significant esophageal varices, then the esophageal probe will not be used.

Emergency cases:

Excluded from the study. Only elective patients will be enrolled.

Short surgeries:

Surgeries that are expected to last 45 minutes or less will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225381

Contacts

Contact: Abraham Rosenbaum, MD

714-456-6753

arosenba@uci.edu

Locations

United States, California
University of California Irvine Medical Center	Recruiting
Orange, California, United States, 92868
Contact: Abraham Rosenbaum, MD 714-456-6753 arosenba@uci.edu
Principal Investigator: Peter H Breen, MD, FRCPC
Sub-Investigator: Abraham Rosenbaum, MD

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:	Peter H Breen, MD, FRCPC	UCI Medical Center
Study Director:	Abraham Rosenbaum, MD	UCI Medical Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

Rosenbaum A, Breen PH. Importance and interpretation of fast-response airway hygrometry during ventilation of anesthetized patients. J Clin Monit Comput. 2007 Jun;21(3):137-46. Epub 2007 Mar 16.

Rosenbaum A, Kirby C, Breen PH. New metabolic lung simulator: development, description, and validation. J Clin Monit Comput. 2007 Apr;21(2):71-82. Epub 2007 Mar 1.

Other Publications:

Rosenbaum A, Kirby C, Breen PH. Measurement of oxygen uptake and carbon dioxide elimination using the bymixer: validation in a metabolic lung simulator. Anesthesiology. 2004 Jun;100(6):1427-37.

Rosenbaum A, Breen PH. Novel, adjustable, clinical bymixer measures mixed expired gas concentrations in anesthesia circle circuit. Anesth Analg. 2003 Nov;97(5):1414-20.

Breen PH, Isserles SA, Taitelman UZ. Non-steady state monitoring by respiratory gas exchange. J Clin Monit Comput. 2000;16(5-6):351-60. Review.

Breen PH. Importance of temperature and humidity in the measurement of pulmonary oxygen uptake per breath during anesthesia. Ann Biomed Eng. 2000 Sep;28(9):1159-64.

Breen PH, Serina ER. Bymixer provides on-line calibration of measurement of CO2 volume exhaled per breath. Ann Biomed Eng. 1997 Jan-Feb;25(1):164-71.

Breen PH, Serina ER, Barker SJ. Measurement of pulmonary CO2 elimination must exclude inspired CO2 measured at the capnometer sampling site. J Clin Monit. 1996 May;12(3):231-6.

Breen PH, Mazumdar B, Skinner SC. Capnometer transport delay: measurement and clinical implications. Anesth Analg. 1994 Mar;78(3):584-6.

Breen PH, Isserles SA, Harrison BA, Roizen MF. Simple computer measurement of pulmonary VCO2 per breath. J Appl Physiol. 1992 May;72(5):2029-35.

Isserles SA, Breen PH. Can changes in end-tidal PCO2 measure changes in cardiac output? Anesth Analg. 1991 Dec;73(6):808-14.

Responsible Party:	UCI Medical Center ( Peter H Breen, MD, FRCPC )
Study ID Numbers:	R01 HL 42637, (UCI IRB ID)2005-4256
Study First Received:	September 21, 2005
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00225381
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Oxygen consumption
CO2 production
Indirect calorimetry
Non steady state

Anesthesia monitoring
Critical events during anesthesia
Acid base balance
Metabolism during anesthesia

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009