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Comparison of Gas Consumption From Two Different Anesthesia Machines

S

St. Olavs Hospital

Status

Completed

Conditions

Female Urogenital Diseases
Male Urogenital Diseases

Treatments

Device: Aisys with Et control
Device: Aisys conventional
Device: Flow-i conventional
Device: Flow-i with ACG

Study type

Interventional

Funder types

Other

Identifiers

NCT02774031
2015/2132

Details and patient eligibility

About

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

.

Enrollment

147 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

147 participants in 4 patient groups

Aisys with Et control
Experimental group
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%.
Treatment:
Device: Aisys with Et control
Aisys conventional ventilation
Active Comparator group
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'
Treatment:
Device: Aisys conventional
Flow-i with ACG
Experimental group
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).
Treatment:
Device: Flow-i with ACG
Flow-I conventional ventilation
Active Comparator group
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'
Treatment:
Device: Flow-i conventional

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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