Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-10

Study Completion Date

2017-12-20

Brief Summary

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Four methods are routinely used to monitor CO2 in patients. End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. CO2 is also monitored in other healthcare settings transcutaneously (TCO2), via finger stick capillary CO2 (CapCO2), and arterial blood gas (ABG). The purpose of this study is to perform all four measurements simultaneously during general anesthesia to identify which measure provides the most accurate data with the least amount of patient risk.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CF

Cystic fibrosis patients undergoing general anesthesia.

Group Type OTHER

End tidal CO2 (EtCO2)

Intervention Type OTHER

End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.

Transcutaneous CO2 (TCO2)

Intervention Type DEVICE

Continuous and noninvasive real-time monitoring of transcutaneous CO2.

Capillary CO2 (CapCO2)

Intervention Type DIAGNOSTIC_TEST

Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.

Arterial blood gas (ABG)

Intervention Type DIAGNOSTIC_TEST

Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.

Interventions

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End tidal CO2 (EtCO2)

End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.

Intervention Type OTHER

Transcutaneous CO2 (TCO2)

Continuous and noninvasive real-time monitoring of transcutaneous CO2.

Intervention Type DEVICE

Capillary CO2 (CapCO2)

Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.

Intervention Type DIAGNOSTIC_TEST

Arterial blood gas (ABG)

Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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The SenTec Digital Monitoring System (SDMS)

Eligibility Criteria

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Inclusion Criteria

* Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype)
* Hemodynamically stable undergoing general anesthesia for a scheduled procedure