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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

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

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Condition or disease Intervention/treatment Phase
Male Urogenital Diseases Female Urogenital Diseases Device: Aisys with Et control Device: Aisys conventional Device: Flow-i with ACG Device: Flow-i conventional Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Gas Consumption With Conventional Low Flow Ventilation and Gas Control Systems From Two Different Anesthesia Machines: Flow-i and Aisys
Actual Study Start Date : May 2016
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : October 20, 2017

Arm Intervention/treatment
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%.
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'
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).
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'
Device: Flow-i conventional



Primary Outcome Measures :
  1. gas consumption in ml/hr [ Time Frame: 1 hour ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774031


Locations
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Norway
Department of Anesthesia, St.Olavs University Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Pål Klepstad, PhD MD St. Olavs Hospital

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02774031    
Other Study ID Numbers: 2015/2132
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by St. Olavs Hospital:
Anesthesia, Inhalation
Laparoscopy
Prostatectomy
Cystectomy
Gynecologic Surgical Procedures
Additional relevant MeSH terms:
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Urologic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs