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Capnography Monitoring in the Bronchoscopic Sedation

Primary Purpose

Hypoventilation

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
A nasal-oral cannula of capnography
Observer Assessment of Alertness and Sedation scale
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoventilation focused on measuring Hypoventilation, capnography, bronchoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung Gung Medical Fundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A nasal-oral cannula of capnography

Sedation scale

Arm Description

Start bronchoscopy when the nasal-oral capnography shows hypoventilation during bronchoscopic sedation.

Start bronchoscopy when Observer Assessment of Alertness and Sedation scale (OAAS)=3~2 during bronchoscopic sedation.

Outcomes

Primary Outcome Measures

Hypoxemia
Oxyhemoglobin saturation less than 90% with any duration after induction to patient recovery.

Secondary Outcome Measures

Patient satisfaction
A 10cm visual analogue scale about how the patients fell about the bronchoscopy
Patient cooperation accessed by bronchoscopists
A 10cm visual analogue scale about how the bronchoscopists fell the cooperation of patients during bronchoscopy.
Induction time
The length of time for achieving adequate sedative depth to start bronchoscopy
Procedure time
The length of time for complete bronchoscopy
Propofol dosage
the dose of propofol for induction and whole bronchoscopy

Full Information

First Posted
March 18, 2015
Last Updated
March 8, 2017
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02848118
Brief Title
Capnography Monitoring in the Bronchoscopic Sedation
Official Title
Capnography Monitoring the Hypoventilation During Bronchoscopic Sedation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoventilation
Keywords
Hypoventilation, capnography, bronchoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A nasal-oral cannula of capnography
Arm Type
Experimental
Arm Description
Start bronchoscopy when the nasal-oral capnography shows hypoventilation during bronchoscopic sedation.
Arm Title
Sedation scale
Arm Type
Active Comparator
Arm Description
Start bronchoscopy when Observer Assessment of Alertness and Sedation scale (OAAS)=3~2 during bronchoscopic sedation.
Intervention Type
Device
Intervention Name(s)
A nasal-oral cannula of capnography
Other Intervention Name(s)
End-tidal CO2
Intervention Description
After propofol infusion, the complete induction is defined when capnography shows hypoventilation and bronchoscope is then introduced to patients.
Intervention Type
Other
Intervention Name(s)
Observer Assessment of Alertness and Sedation scale
Other Intervention Name(s)
OAAS
Intervention Description
After propofol infusion, the complete induction is defined when OAAS is 3 to 2 (conscious sedation) and bronchoscope is then introduced to patients.
Primary Outcome Measure Information:
Title
Hypoxemia
Description
Oxyhemoglobin saturation less than 90% with any duration after induction to patient recovery.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
A 10cm visual analogue scale about how the patients fell about the bronchoscopy
Time Frame
60 minutes
Title
Patient cooperation accessed by bronchoscopists
Description
A 10cm visual analogue scale about how the bronchoscopists fell the cooperation of patients during bronchoscopy.
Time Frame
60 minutes
Title
Induction time
Description
The length of time for achieving adequate sedative depth to start bronchoscopy
Time Frame
10 minutes
Title
Procedure time
Description
The length of time for complete bronchoscopy
Time Frame
30 minutes
Title
Propofol dosage
Description
the dose of propofol for induction and whole bronchoscopy
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Lun Lo, MD
Organizational Affiliation
Chang Gung Medical fundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Gung Medical Fundation
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23638141
Citation
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.
Results Reference
background
PubMed Identifier
15271710
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. doi: 10.1213/01.ANE.0000131964.67524.E7.
Results Reference
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Capnography Monitoring in the Bronchoscopic Sedation

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