Capnography Monitoring in the Bronchoscopic Sedation

Hypoventilation Clinical Trial

Official title:

Capnography Monitoring the Hypoventilation During Bronchoscopic Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848118
• Other study ID #: 104-0872C
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: March 8, 2017
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation

Intervention

Device:
• A nasal-oral cannula of capnography
After propofol infusion, the complete induction is defined when capnography shows hypoventilation and bronchoscope is then introduced to patients.

Other:
• Observer 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.

Locations

Country	Name	City	State
Taiwan	Chung Gung Medical Fundation	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	Oxyhemoglobin saturation less than 90% with any duration after induction to patient recovery.	60 minutes
Secondary	Patient satisfaction	A 10cm visual analogue scale about how the patients fell about the bronchoscopy	60 minutes
Secondary	Patient cooperation accessed by bronchoscopists	A 10cm visual analogue scale about how the bronchoscopists fell the cooperation of patients during bronchoscopy.	60 minutes
Secondary	Induction time	The length of time for achieving adequate sedative depth to start bronchoscopy	10 minutes
Secondary	Procedure time	The length of time for complete bronchoscopy	30 minutes
Secondary	Propofol dosage	the dose of propofol for induction and whole bronchoscopy	60 minutes