Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02068274
Other study ID # 194/12
Secondary ID
Status Completed
Phase N/A
First received February 14, 2014
Last updated August 4, 2017
Start date September 2013
Est. completion date August 2017

Study information

Verified date August 2017
Source Cantonal Hosptal, Baselland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University clinic of internal medicine, Cantonal Hospital Baselland Liestal Baselland

Sponsors (1)

Lead Sponsor Collaborator
Cantonal Hosptal, Baselland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Quantity and quality of pain quality of pain measured using VAS 48 h
Secondary Work quality For Nursing staff Nurses' additional time expense by using the SenTec Monitoring System
Nurses' contentment with the additional Monitoring using SenTec Monitoring System
48 h
Secondary Amount of delivered/demanded doses of consumed opioids 48 h
Secondary Incidence of adverse effects sedation, pruritus, nausea, dryness of the mouth, dizziness, myoclonus, constipation, fatigue, sweating, confusion and hallucinations 48h
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A