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Comparison of Gas Consumption From Two Different Anesthesia Machines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02774031
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Tracking Information
First Submitted Date  ICMJE May 12, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date November 13, 2017
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date October 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
gas consumption in ml/hr [ Time Frame: 1 hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Gas Consumption From Two Different Anesthesia Machines
Official Title  ICMJE Comparing Gas Consumption With Conventional Low Flow Ventilation and Gas Control Systems From Two Different Anesthesia Machines: Flow-i and Aisys
Brief Summary

Low flow anesthesia (LFA) is used less than desirable, partly because one has considered that there might be danger of underdosing of anesthesia gas and thus risk of awareness under anesthesia.LFA has several advantages such as reducing loss of moisture and heat in the inhaled air under anesthesia and to reduce the consumption of anesthetic gas. A few anesthesia machines include an automatic gas control system: the Aisys machine, by GE Healthcare (Madison, WI, USA), and the Flow-i machine, by Maquet (Sweden).

Since these machines were introduced, only a few studies have reported their functionality and effect on gas consumption. 20 to 55% reduction of gas consumption was found. The potential reduction may have been underestimated because in the majority of cases a FGF higher than 1 l/min was still used.

In this study the consumption of anesthetic gas (desflurane) delivered by two different anesthesia machines (Aisys and Flow-i) will be compared, with and without gas control delivery systems. Gas consumption and the time needed to reach the target level of anesthetic gas concentration will be assessed. Data needed will be collected directly from the anesthesia machine, PICIS ( Electronic anesthesia record) and EPJ (Electronic patient journal). The results of this study are of interest for intraoperative ventilation and of economic and ecological interest

.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Male Urogenital Diseases
  • Female Urogenital Diseases
Intervention  ICMJE
  • Device: Aisys with Et control
  • Device: Aisys conventional
  • Device: Flow-i with ACG
  • Device: Flow-i conventional
Study Arms  ICMJE
  • Experimental: Aisys with Et control
    the ventilation modus will be pressure control ventilation with volume guarantee (PCV-VG). Settings: tidal volume (TV) 7-9 ml/kg BW, respiratory rate (RR) 12 -14/min, and 8-10 cmH2O positive end expiratory pressure (PEEP). Target for end expired desflurane concentration (F A des) is set to 4.2%, and target for end expired oxygen (F AO2) is set to 35%.
    Intervention: Device: Aisys with Et control
  • Active Comparator: Aisys conventional ventilation
    50% oxygen and 50% air in 1 liter FGF will be administered. To be started with a FGF of 5l/min and vaporizer setting at 6 Vol% for 5 min. Then the FGF will be reduced to 1 l/min. 25 min later the vaporizer setting will be reduced to 5.5 Vol % for the rest of the study period. Ventilation modus for this group will be the same as for 'Aisys with PCV-VG'
    Intervention: Device: Aisys conventional
  • Experimental: Flow-i with ACG
    the following parameters will be preset: FIO2= 40%; end expired gas concentration (FA des) to 4.2%; speed 6; and ventilation modus = pressure regulated volume control (PRVC) with tidal volume (TV) 7-9 ml/kg BW, respiratory rate (RR)12-14/min, and 8-10 cmH2O positive end expiratory pressure (PEEP).
    Intervention: Device: Flow-i with ACG
  • Active Comparator: Flow-I conventional ventilation
    50% oxygen and 50% air in 1 liter FGF will be administered. To be started with a FGF of 5l/min and vaporizer setting at 6 Vol% for 5 min. Then the FGF will be reduced to 1 l/min. 25 min later the vaporizer setting will be reduced to 5.5 Vol % for the rest of the study period. Ventilation modus for this group will be the same as for 'Flow-i with ACG'
    Intervention: Device: Flow-i conventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2017)
147
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2016)
160
Actual Study Completion Date  ICMJE October 20, 2017
Actual Primary Completion Date October 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing robot assisted laparoscopic prostatectomy, robot assisted laparoscopic cystectomy or robot assisted laparoscopic gynecological surgery

Exclusion Criteria:

  • Cognitive failure, which compromises the ability for an informed consent.
  • Pregnancy
  • American Society of Anesthesiologists physical status classification system (ASA) IV-VI

Patients who are included in the study can be excluded for the following reasons:

  • surgical technical problems (for example surgically impossible to complete the operation with robot assisted surgery)
  • technical problems with the anesthesia machine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02774031
Other Study ID Numbers  ICMJE 2015/2132
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party St. Olavs Hospital
Study Sponsor  ICMJE St. Olavs Hospital
Collaborators  ICMJE Norwegian University of Science and Technology
Investigators  ICMJE
Study Director: Pål Klepstad, PhD MD St. Olavs Hospital
PRS Account St. Olavs Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP