search
Back to results

Comparison of Gas Consumption From Two Different Anesthesia Machines

Primary Purpose

Male Urogenital Diseases, Female Urogenital Diseases

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Aisys with Et control
Aisys conventional
Flow-i with ACG
Flow-i conventional
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Urogenital Diseases focused on measuring Anesthesia, Inhalation, Laparoscopy, Prostatectomy, Cystectomy, Gynecologic Surgical Procedures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesia, St.Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Aisys with Et control

Aisys conventional ventilation

Flow-i with ACG

Flow-I conventional ventilation

Arm Description

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%.

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'

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).

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'

Outcomes

Primary Outcome Measures

gas consumption in ml/hr

Secondary Outcome Measures

Full Information

First Posted
May 12, 2016
Last Updated
November 8, 2017
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT02774031
Brief Title
Comparison of Gas Consumption From Two Different Anesthesia Machines
Official Title
Comparing Gas Consumption With Conventional Low Flow Ventilation and Gas Control Systems From Two Different Anesthesia Machines: Flow-i and Aisys
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 20, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Urogenital Diseases, Female Urogenital Diseases
Keywords
Anesthesia, Inhalation, Laparoscopy, Prostatectomy, Cystectomy, Gynecologic Surgical Procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aisys with Et control
Arm Type
Experimental
Arm Description
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%.
Arm Title
Aisys conventional ventilation
Arm Type
Active Comparator
Arm Description
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'
Arm Title
Flow-i with ACG
Arm Type
Experimental
Arm Description
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).
Arm Title
Flow-I conventional ventilation
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Aisys with Et control
Intervention Type
Device
Intervention Name(s)
Aisys conventional
Intervention Type
Device
Intervention Name(s)
Flow-i with ACG
Intervention Type
Device
Intervention Name(s)
Flow-i conventional
Primary Outcome Measure Information:
Title
gas consumption in ml/hr
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pål Klepstad, PhD MD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesia, St.Olavs University Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison of Gas Consumption From Two Different Anesthesia Machines

We'll reach out to this number within 24 hrs