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Respiratory DepressionNCT03948880

Incidence OIRD Medical and Trauma Patients

An observational study of Respiratory Depression and Sedation, run by Community Health System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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 opioids… 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
101 participants
Where
1 siteUnited States
Study dates
29 Jul 2019to 29 Nov 2019
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 patient-controlled analgesia or nurse administered intravenous opioids for acute pain.

Who may be able to join

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

Who cannot join

  • Age is less than 18 years or greater than 89 years
  • Transfer to the general care floor from the ICU
  • Provider order for respiratory monitoring using continuous capnography
  • Receiving intrathecal or epidural opioids
  • Trauma patient with a nerve block
  • Inability or unwillingness to wear the EtCO2 sampling line nasal cannula or pulse oximetry sensor
Show all 12Show fewer
  • History or diagnosis of a sleep disordered breathing syndrome
  • Use of CPAP or BIPAP non-invasive ventilation as home regime
  • Pre-existing co-morbidity that impacts respiration or ventilation (e.g. COPD or pulmonary fibrosis) (for the purpose of this study a trauma patient with rib fractures is not considered having a pre-existing condition)
  • Receiving non-invasive ventilation
  • Unable or unwilling to participate
  • Member of a vulnerable population such as pregnant women or prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Community Regional Medical Center

    Fresno, California, 93621

Other trials in United States

About this study

Official title: Incidence of OIRD in Medical and Trauma Patients on the General Care Floor Receiving PCA or 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 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.

Medical subject headings
Respiratory Insufficiency

What is being measured

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

  1. Hypoventilation

    The number of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.

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

  2. Hypoventilation

    The percentage of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.

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

  3. Hypoventilation

    The characteristics of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.

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

Secondary outcomes (3)

  1. Hypoxemia

    The number of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.

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

  2. Hypoxemia

    The percentage of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.

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

  3. Hypoxemia

    The characteristics of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.

    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 posted14 May 2019
  2. Study start29 Jul 2019
  3. Primary completion29 Oct 2019 (estimated)
  4. Study completion29 Nov 2019 (estimated)

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
101 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03948880
Sponsor's protocol ID
FresnoCHMC
Status last verified
Jul 2019
First submitted
10 May 2019
Last updated
31 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Arozullah AM, Khuri SF, Henderson WG, Daley J; Participants in the National Veterans Affairs Surgical Quality Improvement Program. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001 Nov 20;135(10):847-57. doi: 10.7326/0003-4819-135-10-200111200-00005.

    PubMed 11712875

  • Belcher AW, Khanna AK, Leung S, Naylor AJ, Hutcherson MT, Nguyen BM, Makarova N, Sessler DI, Devereaux PJ, Saager L. Long-Acting Patient-Controlled Opioids Are Not Associated With More Postoperative Hypoxemia Than Short-Acting Patient-Controlled Opioids After Noncardiac Surgery: A Cohort Analysis. Anesth Analg. 2016 Dec;123(6):1471-1479. doi: 10.1213/ANE.0000000000001534.

    PubMed 27607476

  • Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.

    PubMed 21045639

  • Canet J, Sabate S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.

    PubMed 26020123

  • Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004 Aug;93(2):212-23. doi: 10.1093/bja/aeh180. Epub 2004 May 28.

    PubMed 15169738

  • Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.

    PubMed 18431116

  • Dahan A, Aarts L, Smith TW. Incidence, Reversal, and Prevention of Opioid-induced Respiratory Depression. Anesthesiology. 2010 Jan;112(1):226-38. doi: 10.1097/ALN.0b013e3181c38c25.

    PubMed 20010421

  • Dempsey, SF, Khanna, AK, Buhre, W, Saager, L, DiStefano, P, Weingarten, T., Dahan, A., Brazzi, L., Overdyk, F., McIntyre, R. Incidence of Respiratory Depression and Derivation of a Novel Opioid-Induced Respriatory Depression Risk Prediction Tool. Poster presentation. UCLA School of Nursing Research Day, May 14, 2019.

  • Gupta K, Prasad A, Nagappa M, Wong J, Abrahamyan L, Chung FF. Risk factors for opioid-induced respiratory depression and failure to rescue: a review. Curr Opin Anaesthesiol. 2018 Feb;31(1):110-119. doi: 10.1097/ACO.0000000000000541.

    PubMed 29120929

  • Izrailtyan I, Qiu J, Overdyk FJ, Erslon M, Gan TJ. Risk factors for cardiopulmonary and respiratory arrest in medical and surgical hospital patients on opioid analgesics and sedatives. PLoS One. 2018 Mar 22;13(3):e0194553. doi: 10.1371/journal.pone.0194553. eCollection 2018.

    PubMed 29566020

  • 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

  • Khanna, A, Buhre, W, Saager, L, DiStefano, P, Weingarten, R, Dahan, A, Brazzi, L, & Overdyk, R. Derivation and validation of a novel opioid-induced respiratory depression risk predication tool. Critical Care Medicine 47(1):36, 2019.

  • Khanna AK, Sessler DI, Sun Z, Naylor AJ, You J, Hesler BD, Kurz A, Devereaux PJ, Saager L. Using the STOP-BANG questionnaire to predict hypoxaemia in patients recovering from noncardiac surgery: a prospective cohort analysis. Br J Anaesth. 2016 May;116(5):632-40. doi: 10.1093/bja/aew029.

    PubMed 27106966

  • Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013 Apr;33(4):383-91. doi: 10.1002/phar.1223.

    PubMed 23553809

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Depression and Sedation, run by Community Health System at 1 site in United States.

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 12 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: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Results are not available in the source record.

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). The study lists 3 primary outcomes in all. 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 NCT03948880, which also lists 26 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 31 Jul 2019.

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