Incidence OIRD Medical and Trauma Patients

NCT03948880 | Unknown

• 1 other identifier: FresnoCHMC
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Respiratory Depression; Sedation

Outcome Measures

Primary Outcomes (3)

• Hypoventilation

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

  Change from baseline measurement observed within 60 minutes after opioid administration

• Hypoventilation

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

  Change from baseline measurement observed within 60 minutes after opioid administration

• Hypoventilation

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

  Change from baseline measurement observed within 60 minutes after opioid administration

Secondary Outcomes (3)

• Hypoxemia

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

• Hypoxemia

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

• Hypoxemia

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

Other Outcomes (9)

• Sedation

  Change from baseline assessment observed within 60 minutes after opioid administration ]

• Sedation

  Change from baseline assessment observed within 60 minutes after opioid administration ]

• Sedation

  Change from baseline assessment observed within 60 minutes after opioid administration ]

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fresno Community Hospital and Medical Center: lead
• University of California, Los Angeles: collaborator
• Medtronic: collaborator

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93621, United States

Location

Related Publications (26)

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  BACKGROUND

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  BACKGROUND

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• Weingarten TN, Herasevich V, McGlinch MC, Beatty NC, Christensen ED, Hannifan SK, Koenig AE, Klanke J, Zhu X, Gali B, Schroeder DR, Sprung J. Predictors of Delayed Postoperative Respiratory Depression Assessed from Naloxone Administration. Anesth Analg. 2015 Aug;121(2):422-9. doi: 10.1213/ANE.0000000000000792.

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MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Susan J Dempsey, PhD(c)

  UCLA and Community Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Specialist

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: July 29, 2019
• Primary Completion: October 29, 2019
• Study Completion: November 29, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)