CO2 Monitoring Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Cantonal Hosptal, Baselland
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier:
NCT02068274
First received: February 14, 2014
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

Opioids are an effective instrument for patients with acute and chronic pain. Their route of administration ranges from transdermal to subcutaneous application through to Intravenous Patient-Controlled Analgesia (IV-PCA).

The use of IV-PCA-pumps has considerable advantages including decreased delay in the administration of opioids from the time requested, individual dose intervals, self -control of their therapy, rapidity and ease of dose titration . These potential benefits, however are balanced by the need for careful assessment of adverse effects, including decreased quality of life because of the patient's sedation, constipation and possible episodes of bradypnoea and desaturation, eventually leading to respiratory depression (RD) requiring treatment. Often described safety features that help prevent overdosing are PCA bolus dose, delay, and lockout interval.

Even though the risk of serious, potentially life threatening complications by using IV-PCA without a background infusion was described to be very low (0.24%) compared to other methods of opioid delivery , adverse effects like worrying degrees of hypoxemia and bradypnoea do occur and often remain undetected due to the lack of continuous monitoring. One of the possible causes of patient harm are medication errors associated with PCA administration, a common form of PCA errors, which is a significant source of preventable patient morbidity and hospital resource utilization.

The individual patient response to a particular dose of opioids depends on diagnosed or unrecognized comorbidities. Clinical experience has shown that it is not possible to prospectively identify all patients who may be at increased risk.

Conventional opioid monitoring protocol may fail to detect frequent episodes of bradypnoea and desaturation measured by the respiratory rate (RR) and Saturation of Peripheral Oxygen (SpO2) because even at a low respiratory rate SpO2 is usually maintained, so that pulse oxymetry might fail to detect respiratory deterioration, particularly if a patient is receiving supplemental oxygen.

Therefore, continuous monitoring could be considered more sensitive, especially if it contains the measurement of Partial Pressure of Carbon dioxide (PCO2), which is a good parameter for monitoring ventilatory function.

The 'gold standard' method to measure the arterial partial pressure of carbon dioxide (PaCO2) is still the arterial blood gas analysis. But arterial sampling including catheterization or intermittent arterial puncture is invasive and expensive and associated with pain and discomfort for the patient. Therefore cutaneous carbon dioxide tension (PcCO2) measurement was suggested to be used as a non-invasive surrogate measure of PaCO2.

SpO2, and tcPCO2, are important clinical parameters that should be used in conjunction with each other. SpO2 reflects oxygenation, while tcPCO2 reflects ventilation; the first can still be normal while the second may herald early changes in respiratory status. Capnography may provide the earliest indication of opioid-induced respiratory depression. It is important to monitor changes from a baseline tcPCO2 level. As the tcPCO2 level starts to increase, early intervention and changes in medication can be made.

The present study aims to examine combined oxymetry and transcutaneous capnography using a single earlobe sensor (V-Sign™, Sentec AG, Therwil, Switzerland) in chronic pain patients treated with opioids where non-invasive monitoring of ventilation is needed because ventilatory disturbances are suspected. This may, potentially, improve patient's quality of life.


Condition
Chronic Pain
Hypercapnia
Quality of Life

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Monitoring of Patients Treated With Opioids for Chronic Pain and Its Impact on Patient Safety. A Feasibility Trial.

Resource links provided by NLM:


Further study details as provided by Cantonal Hosptal, Baselland:

Primary Outcome Measures:
  • Number of events of respiratory depression and/or respiratory Depression [ Time Frame: 48 h ] [ Designated as safety issue: No ]
    -Number of events of respiratory depression (PtcCO2 ≥ 6.0 kPa (≥45mmHg) and/or a decrease of respiratory rate on less than 8 breaths per minute) after 48 h of measuring by Sentec Monitoring System


Secondary Outcome Measures:
  • Quantity and quality of pain [ Time Frame: 48 h ] [ Designated as safety issue: No ]
    quality of pain measured using VAS

  • Work quality For Nursing staff [ Time Frame: 48 h ] [ Designated as safety issue: No ]
    • Nurses' additional time expense by using the SenTec Monitoring System
    • Nurses' contentment with the additional Monitoring using SenTec Monitoring System

  • Amount of delivered/demanded doses of consumed opioids [ Time Frame: 48 h ] [ Designated as safety issue: No ]
  • Incidence of adverse effects [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
    sedation, pruritus, nausea, dryness of the mouth, dizziness, myoclonus, constipation, fatigue, sweating, confusion and hallucinations


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
chronic pain
CO2 monitoring in chronic pain patients who treated with opioids.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pain patients treated with opioids

Criteria

Inclusion Criteria:

  • Older than 18 years
  • Capable of giving informed consent
  • Needing opioids (oral, transdermal, subcutaneous, IV-PCA) for pain control (opioid naïve or patients on chronic opioid therapy )

Exclusion Criteria:

  • No consent for participation
  • Absence of power of judgment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068274

Locations
Switzerland
University clinic of internal medicine, Cantonal Hospital Baselland Recruiting
Liestal, Baselland, Switzerland, 4410
Contact: Joerg D Leuppi, Prof. MD, PhD    0041619252180    joerg.leuppi@ksbl.ch   
Principal Investigator: Jörg D Leuppi, Prof. MD. PhD         
Sponsors and Collaborators
Cantonal Hosptal, Baselland
  More Information

No publications provided

Responsible Party: Prof. Dr. Jörg Leuppi, Chief of University Internal medicine Clinic, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier: NCT02068274     History of Changes
Other Study ID Numbers: 194/12
Study First Received: February 14, 2014
Last Updated: February 19, 2014
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014