Gas Kinetics and Metabolism in Anesthesia During Non Steady State

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00225381
First received: September 21, 2005
Last updated: February 10, 2011
Last verified: February 2011
  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 1

Study Type: Observational
Study Design: Observational Model: 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 ]

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.
Other Name: V&F Instruments, Airsense (www.vandf.com)
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.
Patients requiring tourniquet during surgery
Patients undergoing orthopaedic surgeries requiring tourniquet intervention. Oxygen consumption and CO2 production were measured before, during and after tourniquet release.
Patients prone to metabolic acidosis
Oxygen consumption and CO2 measurements taken during long surgeries prone to metabolic acidosis.

  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 infarction 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:

Responsible Party: Peter H Breen, MD, FRCPC, UCI Medical Center
ClinicalTrials.gov Identifier: NCT00225381     History of Changes
Other Study ID Numbers: R01 HL 42637, (UCI IRB ID)2005-4256
Study First Received: September 21, 2005
Last Updated: February 10, 2011
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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014