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Respiratory DepressionNCT02707003

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

An observational study of Respiratory Depression, run by Medtronic - MITG at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Depression
How many people
250 participants
Where
2 sitesin 2 countries
Study dates
Feb 2016to 15 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults booked for a surgical procedure that meet the I/E criteria and willing to provide consent for observation in the PACU and chart review 24 hours post PACU discharge.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Banner University Medical Center

    Tucson, Arizona, 85724-5114

Other trials in United States

Canada1 site

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: A Multi-Center Pilot Observational Trial to Quantify the Potential Clinical Utility of Capnography in the PACU

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)

Read the detailed description

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.

Keywords
Post-operative respiratory distress
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02707003
Study groupRoleWhat they receive
AZ PACUObservation of standard of care with capnography blinded
TWH PACUObservation of standard of care with capnography blinded

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of Respiratory Adverse Events in the PACU identified by capnography

    Identification by blinded capnography to understand the ventilation challenges of patient in the PACU during standard of care that does not include capnography. First tier is RN (Registered Nurse) level of notification for early intervention and second tier is level at which covering MD (Medical Doctor) might request notification:

    1. High Respiration Rate >25 bpm for > 15 seconds (tier one) and >30 bpm for more than 30 seconds (tier two)
    2. Low Respiration Rate < 8 bpm for more than 15 seconds and < 6 bpm for more than 30 seconds
    3. High end tidal CO2 (EtCO2) > 55 mmHg for > 15 seconds and > 60 mmHg for more than 30 seconds
    4. Low EtCO2 < 25 mmHg for > 15 seconds and < 25 mmHg for more than 30 seconds
    5. High Heart Rate > 120/min for 15 seconds and >120/min for 30 seconds
    6. Low Heart Rate < 40/min for 15 seconds and < 40/min for 30 seconds
    7. SpO2 (oxygen saturation by pulse oximetry) /Hypoxemia < 90% for more than 15 seconds and< 90% for more than 30 seconds

    Measured: Up to 2 hours in the PACU

Secondary outcomes (2)

  1. Frequency of Critical Adverse Events (CRAE)

    Critical CRAE in the PACU or in 24 hour post PACU chart review:

    1. Narcotic overdose that required an Opioid reversal
    2. Partial airway obstruction that required an NMBA (neuromuscular blocking agent) antagonist
    3. Respiratory Insufficiency that would require Non-invasive positive pressure ventilation, ambu bag mask assisted ventilation
    4. Respiratory failure that would Invasive mechanical ventilation
    5. Upper airway obstruction requiring airway support measures (oral or nasal) such as intubation, LMA (laryngeal mask airway), or airway
    6. Respiratory insufficiency/failure that would require a transfer to the ICU
    7. Cardiopulmonary arrest
    8. Death due to respiratory/pulmonary related complications Other (free text that might capture aspiration, pneumothorax)

    Measured: PACU and 24 hours post PACU

  2. Ventilation insufficiency on transfer from the PACU

    Population of patients leaving the PACU in early stage ventilation respiratory insufficiency as defined as etCO2 ≤ 25 mmHg or etCO2 ≥55 mmHg combined with low RR (respiratory rate) and hypotension within 15 minutes before transport out of the PACU.

    Measured: At PACU discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completion15 Jun 2017
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02707003
Sponsor's protocol ID
COVMOPO0526
Status last verified
Jul 2020
First submitted
7 Mar 2016
Last updated
23 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kanaparthi A, Chung F, Lichtenthal PR, Sprung J, Weingarten TN. PRODIGY score predicts respiratory depression in the post-anesthesia care unit: A post-hoc analysis. Biomol Biomed. 2024 Oct 17;24(6):1662-1668. doi: 10.17305/bb.2024.10585.

    PubMed 38843498

  • Chung F, Wong J, Mestek ML, Niebel KH, Lichtenthal P. Characterization of respiratory compromise and the potential clinical utility of capnography in the post-anesthesia care unit: a blinded observational trial. J Clin Monit Comput. 2020 Jun;34(3):541-551. doi: 10.1007/s10877-019-00333-9. Epub 2019 Jun 7.

    PubMed 31175500

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Depression, run by Medtronic - MITG at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Respiratory Adverse Events in the PACU identified by capnography (time frame: Up to 2 hours in the PACU). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02707003, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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