Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-09

Study Completion Date

2018-09-05

Brief Summary

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This is a clinical, single blind, randomized, prospective research study. The purpose of this pivotal study is to collect and analyze data on the investigational End tidal Control (Et Control) option feature. To demonstrate that End tidal Control (Et Control) performance is non-inferior to conventional anesthesia practice in an adult surgery population by comparing the performance of the Et Control Arm (investigational arm) to the Control Arm (fresh gas mode).

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Detailed Description

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The purpose of this pivotal study is to demonstrate that End tidal Control performance is non-inferior to conventional anesthesia practice in an adult surgery population, and support a marketing application in the U.S. for clearance of this feature.

Conditions

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Et Control Performance in Adult Population Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Et Control

Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.

Group Type EXPERIMENTAL

Et Control Feature

Intervention Type DEVICE

Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.

Control Arm

Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.

Group Type ACTIVE_COMPARATOR

Conventional Fresh Gas

Intervention Type DEVICE

Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.

Interventions

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Et Control Feature

Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.

Intervention Type DEVICE

Conventional Fresh Gas

Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female 18 years old or greater.
2. Scheduled to undergo general inhaled anesthesia that can be safely exposed to 100% oxygen for up to 2 minutes during general anesthesia.
3. Expected to have airway secured with laryngeal mask airway (LMA) or endotracheal tube.
4. Undergoing a surgical procedure that is anticipated by the investigator to take greater than or equal to 1 hour (operative time measured from induction to cessation of general inhalation anesthetic).
5. American Society of Anesthesiologists (ASA) status classification system I through III:

1. ASA Physical Status 1 = a normal healthy patient
2. ASA Physical Status 2 = a patient with mild systemic disease
3. ASA Physical Status 3 = a patient with severe systemic disease
6. Undergoing intravenous induction.
7. Ability to provide written informed consent.

Exclusion Criteria

1. Have emergency medical condition requiring surgery.
2. Are female subjects, who are pregnant or lactating.
3. Any subject undergoing cardiac bypass surgery.
4. Any subject undergoing open chest surgery.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No