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Respiratory DepressionNCT03647696

Incidence of Opioid-Induced Respiratory Depression in Medical and Trauma Patients

An observational study of Respiratory Depression and Sedation, run by Poudre Valley Health System.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous (IV)… Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Respiratory Depression, Sedation
How many people
0 participants
Where
No sites listed yet
Study dates
30 Aug 2018to 30 Aug 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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The target study population will be hospitalized, adult medical or trauma patients on the general care floor receiving PCA or nurse administered IV opioids for acute pain.

Who may be able to join

  • Spontaneously breathing adults 18 to 89 years of age
  • English speaking
  • Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
  • Admitted to the general care floor from the emergency department

Who cannot join

  • Less than 18 or greater than 89 years of age
  • Transfer to the general care floor from the Intensive Care Unit
  • Receiving intrathecal or epidural opioids
  • Inability or unwillingness to wear the etCO2 sampling line nasal cannula or pulse oximetry sensor
  • History or diagnosis of a sleep disordered breathing syndrome
  • Use of Continuous Positive Airway Pressure or (CPAP) or Bilevel Positive Airway Pressure (BIPAP) non-invasive ventilation as home regime
Show all 10Show fewer
  • Receiving non-invasive ventilation
  • Presence of a co-morbidity that impacts respiration or ventilation (e.g Chronic Obstructive Pulmonary Disease or Pulmonary Fibrosis)
  • Unwilling or unable to participate
  • Member of a vulnerable population such as pregnant women or prisoners.

About this study

Official title: Incidence of Opioid-induced Respiratory Depression in Medical and Trauma Patients on the General Care Floor Receiving Patient-controlled Analgesia and Nurse Administered Intravenous Opioids Monitored by Capnography and Pulse Oximetry: A Prospective, Blinded Observational Study

The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous (IV) opioids for acute pain. Nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. The secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.

Keywords
respiratory depression, opioid-induced sedation
Medical subject headings
Respiratory Insufficiency

What is being measured

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

  1. Hypoventilation

    Continuous respiratory monitoring using capnography will be performed for collecting data of end-tidal carbon dioxide (etCO2)

    Measured: Change from baseline measurement observed within 60 minutes after opioid administration

Secondary outcomes (1)

  1. Hypoxemia

    Continuous respiratory monitoring using pulse oximetry will be performed for collecting data of oxygen saturation (SpO2)

    Measured: Change from baseline measurement observed within 60 minutes after opioid administration

Timeline

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

  1. First posted27 Aug 2018
  2. Study start30 Aug 2018
  3. Primary completion30 Aug 2018
  4. Study completion30 Aug 2018

Why it stopped: Principal Investigator left institution and took the study them.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03647696
Sponsor's protocol ID
PoudreVHS
Status last verified
Jun 2021
First submitted
22 Aug 2018
Last updated
11 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It is not decided whether the data will be available for sharing

Publications

  • Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.

    PubMed 26287299

  • Stites M, Surprise J, McNiel J, Northrop D, De Ruyter M. Continuous Capnography Reduces the Incidence of Opioid-Induced Respiratory Rescue by Hospital Rapid Resuscitation Team. J Patient Saf. 2021 Sep 1;17(6):e557-e561. doi: 10.1097/PTS.0000000000000408.

    PubMed 28731933

  • Perman SM, Stanton E, Soar J, Berg RA, Donnino MW, Mikkelsen ME, Edelson DP, Churpek MM, Yang L, Merchant RM; American Heart Association's Get With the Guidelines(R)-Resuscitation (formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Location of In-Hospital Cardiac Arrest in the United States-Variability in Event Rate and Outcomes. J Am Heart Assoc. 2016 Sep 29;5(10):e003638. doi: 10.1161/JAHA.116.003638.

    PubMed 27688235

  • Churpek MM, Yuen TC, Huber MT, Park SY, Hall JB, Edelson DP. Predicting cardiac arrest on the wards: a nested case-control study. Chest. 2012 May;141(5):1170-1176. doi: 10.1378/chest.11-1301. Epub 2011 Nov 3.

    PubMed 22052772

  • Andersen LW, Berg KM, Chase M, Cocchi MN, Massaro J, Donnino MW; American Heart Association's Get With The Guidelines((R))-Resuscitation Investigators. Acute respiratory compromise on inpatient wards in the United States: Incidence, outcomes, and factors associated with in-hospital mortality. Resuscitation. 2016 Aug;105:123-9. doi: 10.1016/j.resuscitation.2016.05.014. Epub 2016 May 30.

    PubMed 27255952

  • Lee LA, Caplan RA, Stephens LS, Posner KL, Terman GW, Voepel-Lewis T, Domino KB. Postoperative opioid-induced respiratory depression: a closed claims analysis. Anesthesiology. 2015 Mar;122(3):659-65. doi: 10.1097/ALN.0000000000000564.

    PubMed 25536092

  • Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L, Dempsey SJ, Santangelo D, Polomano RC. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011 Sep;12(3):118-145.e10. doi: 10.1016/j.pmn.2011.06.008.

    PubMed 21893302

  • Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010 Feb;112(2):282-7. doi: 10.1097/ALN.0b013e3181ca7a9b.

    PubMed 20098128

  • Taenzer AH, Pyke J, Herrick MD, Dodds TM, McGrath SP. A comparison of oxygen saturation data in inpatients with low oxygen saturation using automated continuous monitoring and intermittent manual data charting. Anesth Analg. 2014 Feb;118(2):326-331. doi: 10.1213/ANE.0000000000000049.

    PubMed 24361847

  • Davis C, Geik C, Arthur K, Fuller J, Johnston E, Levitt F, Leung E, McCart G, McMichael D, Painter J, Staublin T, Walroth T. A Multisite Retrospective Study Evaluating the Implementation of the Pasero Opioid-Induced Sedation Scale (POSS) and Its Effect on Patient Safety Outcomes. Pain Manag Nurs. 2017 Aug;18(4):193-201. doi: 10.1016/j.pmn.2017.03.006. Epub 2017 Jun 9.

    PubMed 28606595

  • Morris TA, Gay PC, MacIntyre NR, Hess DR, Hanneman SK, Lamberti JP, Doherty DE, Chang L, Seckel MA. Respiratory Compromise as a New Paradigm for the Care of Vulnerable Hospitalized Patients. Respir Care. 2017 Apr;62(4):497-512. doi: 10.4187/respcare.05021.

    PubMed 28341777

  • Henneman EA, Gawlinski A, Giuliano KK. Surveillance: A strategy for improving patient safety in acute and critical care units. Crit Care Nurse. 2012 Apr;32(2):e9-18. doi: 10.4037/ccn2012166.

    PubMed 22467622

  • Moline B, Roberts M, Houser J. Validity and interrater reliability of the Moline-Roberts Pharmacologic Sedation Scale. Clin Nurse Spec. 2012 May-Jun;26(3):140-8. doi: 10.1097/NUR.0b013e3182503fd6.

    PubMed 22504472

  • Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007 Aug;105(2):412-8. doi: 10.1213/01.ane.0000269489.26048.63.

    PubMed 17646499

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Depression and Sedation, run by Poudre Valley Health System.

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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Hypoventilation (time frame: Change from baseline measurement observed within 60 minutes after opioid administration). 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 NCT03647696, which also lists 14 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 11 Jun 2021.

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