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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02774031
Other study ID # 2015/2132
Secondary ID
Status Completed
Phase N/A
First received May 12, 2016
Last updated November 8, 2017
Start date May 2016
Est. completion date October 20, 2017

Study information

Verified date November 2017
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date October 20, 2017
Est. primary completion date October 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Aisys with Et control

Aisys conventional

Flow-i with ACG

Flow-i conventional


Locations

Country Name City State
Norway Department of Anesthesia, St.Olavs University Hospital Trondheim

Sponsors (2)

Lead Sponsor Collaborator
St. Olavs Hospital Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary gas consumption in ml/hr 1 hour
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