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Capnography Monitoring in the Bronchoscopic Sedation

Capnography Monitoring the Hypoventilation During Bronchoscopic Sedation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02848118
Enrollment
124
Registered
2016-07-28
Start date
2015-01-31
Completion date
2016-12-31
Last updated
2017-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoventilation

Keywords

Hypoventilation, capnography, bronchoscopy

Brief summary

Procedure sedation of flexible bronchoscopy (FB) comforts patients undergoing FB. Hypoventilation during FB is a concern. The investigators investigate the feasibility of monitoring capnography in FB sedation.

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.

Interventions

DEVICEA nasal-oral cannula of capnography

After propofol infusion, the complete induction is defined when capnography shows hypoventilation and bronchoscope is then introduced to patients.

OTHERObserver Assessment of Alertness and Sedation scale

After propofol infusion, the complete induction is defined when OAAS is 3 to 2 (conscious sedation) and bronchoscope is then introduced to patients.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hypoxemia60 minutesOxyhemoglobin saturation less than 90% with any duration after induction to patient recovery.

Secondary

MeasureTime frameDescription
Patient satisfaction60 minutesA 10cm visual analogue scale about how the patients fell about the bronchoscopy
Patient cooperation accessed by bronchoscopists60 minutesA 10cm visual analogue scale about how the bronchoscopists fell the cooperation of patients during bronchoscopy.
Induction time10 minutesThe length of time for achieving adequate sedative depth to start bronchoscopy
Procedure time30 minutesThe length of time for complete bronchoscopy
Propofol dosage60 minutesthe dose of propofol for induction and whole bronchoscopy

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026