- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02848118
Capnography Monitoring in the Bronchoscopic Sedation
Capnography Monitoring the Hypoventilation During Bronchoscopic Sedation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing flexible bronchoscopy (FB) experience procedure-related symptoms. Current guidelines of FB recommend sedation to all patients undergoing FB, except when there are contraindications. Propofol or benzodiazepines plus an opioid are the common combination used to improve patient tolerance and satisfaction during FB. However, controversy about combining propofol and opioids persists because of the risk of over-sedation and cardiopulmonary depression.
While transition from alert into sedation during induction, like sleep, the respiratory drive and muscle tone of respiratory muscle and upper airway attenuate, which contribute hypoventilation and upper airway collapse, and further hypoxemia. Detection of cardiopulmonary depression traditionally has relied on continuous monitoring of heart rate, respiratory rate, and oxygen saturation. However, it has been shown that these monitors could not recognize hypoventilation early. Similar with other published data, around 40% of hypoxemia event occurred during FB sedation in our hospital. Further analysis of our data revealed around 15% event occurred during sedative induction.
Capnography is the noninvasive measurement of the partial pressure of carbon dioxide (CO2) from the airway during ventilation. The maximum partial pressure of CO2 obtained at the end of an exhaled breath is referred to as end-tidal CO2 (EtCO2). Studies have revealed the waveform analysis of capnography can provide early warning for prehypoxic respiratory depression in patients undergoing procedure sedation in emergency department and gastrointestinal endoscopy. Therefore, capnography can serve as a real-time measure of ventilatory status of sedative patients and the physicians could intervene before the occurrence of hypoxemia. Based on the advantage of non-invasive and real-time property of EtCO2 monitored by capnography, the investigators plan to conduct a clinical trial to evaluate if hypoxemia could be reduced by capnography of EtCO2 monitor during induction of FB sedation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taoyuan, Taiwan, 333
- Chung Gung Medical Fundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing elective bronchoscopy and sedation
Exclusion Criteria:
- Age less than 18 years
- American Society of Anaesthesiologists (ASA) physical status classification IV or V
- Mallampati score of 4
- Severe sleep apnoea syndrome (apnoea-hypopnea index more than 40)
- Body mass index more than 42 in males or 35 in females
- Neurologic disorders or other conditions contributing to difficulty in assessing response
- Forced expiratory vital capacity (FVC) less than 15 ml/kg body weight, forced expiratory volume in one second (FEV1) less than 1000 ml, or FEV1/FVC less than 35%
- Chronic use of opioid drugs
- Pregnancy
- Patients with a known history of allergy to the study drugs, or to eggs, soybeans or sulfite products
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A nasal-oral cannula of capnography
Start bronchoscopy when the nasal-oral capnography shows hypoventilation during bronchoscopic sedation.
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After propofol infusion, the complete induction is defined when capnography shows hypoventilation and bronchoscope is then introduced to patients.
Other Names:
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ACTIVE_COMPARATOR: Sedation scale
Start bronchoscopy when Observer Assessment of Alertness and Sedation scale (OAAS)=3~2 during bronchoscopic sedation.
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After propofol infusion, the complete induction is defined when OAAS is 3 to 2 (conscious sedation) and bronchoscope is then introduced to patients.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypoxemia
Time Frame: 60 minutes
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Oxyhemoglobin saturation less than 90% with any duration after induction to patient recovery.
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60 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: 60 minutes
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A 10cm visual analogue scale about how the patients fell about the bronchoscopy
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60 minutes
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Patient cooperation accessed by bronchoscopists
Time Frame: 60 minutes
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A 10cm visual analogue scale about how the bronchoscopists fell the cooperation of patients during bronchoscopy.
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60 minutes
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Induction time
Time Frame: 10 minutes
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The length of time for achieving adequate sedative depth to start bronchoscopy
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10 minutes
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Procedure time
Time Frame: 30 minutes
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The length of time for complete bronchoscopy
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30 minutes
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Propofol dosage
Time Frame: 60 minutes
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the dose of propofol for induction and whole bronchoscopy
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60 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yu-Lun Lo, MD, Chang Gung Medical fundation
Publications and helpful links
General Publications
- Lin TY, Lo YL, Hsieh CH, Ni YL, Wang TY, Lin HC, Wang CH, Yu CT, Kuo HP. The potential regimen of target-controlled infusion of propofol in flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2013 Apr 24;8(4):e62744. doi: 10.1371/journal.pone.0062744. Print 2013.
- Soto RG, Fu ES, Vila H Jr, Miguel RV. Capnography accurately detects apnea during monitored anesthesia care. Anesth Analg. 2004 Aug;99(2):379-82, table of contents. doi: 10.1213/01.ANE.0000131964.67524.E7.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 104-0872C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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