Clinical Utility of Capnography in the PACU( Post-anaesthesia Care Unit)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-06-15

Brief Summary

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Multi-center observational trial with study device blinded in order to assess in parallel standard monitoring and intervention practices related to management of respiratory compromise in the post-anaesthesia care unit (PACU)

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Detailed Description

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All Study device information is blinded to medical staff but the Study Coordinator will have full access to device measurements, alarms, notification and events via a local Wi-Fi hub sent to a portable tablet. The tablet Case Report Form (CRF) will allow all observation be inserted with a time stamp on the electronic device data. In addition, all electronic data will be collected from the bedside monitor.

Conditions

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Respiratory Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AZ PACU

Observation of standard of care with capnography blinded

No interventions assigned to this group

TWH PACU

Observation of standard of care with capnography blinded

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Adult ≥ 18 years of age
2. ASA Score II - IV (American Society of Anaesthesiologists Score)
3. Patients booked for a surgical procedure requiring general anesthesia care
4. Expected duration of general anesthesia to be \> 1.5 hours
5. Expected to receive intraoperative opioids
6. Expected to be transferred to the PACU from the operating room
7. Patients with an expected duration in the PACU ≥ 45 minutes
8. Expected to be transferred from the PACU to an in-patient setting

Exclusion Criteria

1. Patients expected to be discharged from the hospital when discharged from the PACU
2. Subjects who will have oral/nasal surgery that may prevent wearing an oral/nasal capnography sampling filterline.
3. Subjects with a history of severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors.
4. Patients with skin lesions or physical deformities that would prevent the application of finger sensors for optimal performance.
5. A female known to be pregnant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No