CO2 Monitoring Study

NCT02068274 | Completed

• 1 other identifier: 194/12
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Hypercapnia; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Number of events of respiratory depression and/or respiratory Depression

  -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

  48 h

Secondary Outcomes (4)

• Quantity and quality of pain

  48 h

• Work quality For Nursing staff

  48 h

• Amount of delivered/demanded doses of consumed opioids

  48 h

• Incidence of adverse effects

  48h

Study Arms (1)

chronic pain

CO2 monitoring in chronic pain patients who treated with opioids.

Eligibility Criteria

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

Study Population

Pain patients treated with opioids

You may qualify if:

• 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 )

You may not qualify if:

• No consent for participation
• Absence of power of judgment

Sponsors & Collaborators

• Cantonal Hosptal, Baselland: lead

Study Sites (1)

University clinic of internal medicine, Cantonal Hospital Baselland

Liestal, Basel-Landschaft, 4410, Switzerland

Location

MeSH Terms

Conditions

Chronic Pain; Hypercapnia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of University Internal medicine Clinic

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 21, 2014
• Study Start: September 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

CH (1)