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Capnography Monitoring in the Bronchoscopic Sedation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02848118
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Yu-Lun Lo, Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE March 18, 2015
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date March 9, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
Hypoxemia [ Time Frame: 60 minutes ]
Oxyhemoglobin saturation less than 90% with any duration after induction to patient recovery.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02848118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • Patient satisfaction [ Time Frame: 60 minutes ]
    A 10cm visual analogue scale about how the patients fell about the bronchoscopy
  • Patient cooperation accessed by bronchoscopists [ Time Frame: 60 minutes ]
    A 10cm visual analogue scale about how the bronchoscopists fell the cooperation of patients during bronchoscopy.
  • Induction time [ Time Frame: 10 minutes ]
    The length of time for achieving adequate sedative depth to start bronchoscopy
  • Procedure time [ Time Frame: 30 minutes ]
    The length of time for complete bronchoscopy
  • Propofol dosage [ Time Frame: 60 minutes ]
    the dose of propofol for induction and whole bronchoscopy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capnography Monitoring in the Bronchoscopic Sedation
Official Title  ICMJE Capnography Monitoring the Hypoventilation During Bronchoscopic Sedation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Hypoventilation
Intervention  ICMJE
  • 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 Name: End-tidal CO2
  • 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.
    Other Name: OAAS
Study Arms  ICMJE
  • Experimental: A nasal-oral cannula of capnography
    Start bronchoscopy when the nasal-oral capnography shows hypoventilation during bronchoscopic sedation.
    Intervention: Device: A nasal-oral cannula of capnography
  • Active Comparator: Sedation scale
    Start bronchoscopy when Observer Assessment of Alertness and Sedation scale (OAAS)=3~2 during bronchoscopic sedation.
    Intervention: Other: Observer Assessment of Alertness and Sedation scale
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2016)
124
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02848118
Other Study ID Numbers  ICMJE 104-0872C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yu-Lun Lo, Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yu-Lun Lo, MD Chang Gung Medical fundation
PRS Account Chang Gung Memorial Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP