HypoventilationNCT02848118
Capnography Monitoring in the Bronchoscopic Sedation
A study testing A nasal-oral cannula of capnography and Observer Assessment of Alertness and Sedation scale in people with Hypoventilation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoventilation
- What is being tested?
- A nasal-oral cannula of capnography and Observer Assessment of Alertness and Sedation scale
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective bronchoscopy and sedation
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capnography Monitoring the Hypoventilation During Bronchoscopic Sedation
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.
Read the 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.
- Conditions
- Hypoventilation
- Being tested
- A nasal-oral cannula of capnography, Observer Assessment of Alertness and Sedation scale
- Keywords
- Hypoventilation, capnography, bronchoscopy
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A nasal-oral cannula of capnographyDevice
Also called End-tidal CO2
After propofol infusion, the complete induction is defined when capnography shows hypoventilation and bronchoscope is then introduced to patients.
Observer Assessment of Alertness and Sedation scaleOther
Also called OAAS
After propofol infusion, the complete induction is defined when OAAS is 3 to 2 (conscious sedation) and bronchoscope is then introduced to patients.
| Study group | Role | What they receive |
|---|---|---|
| A nasal-oral cannula of capnography | Experimental | Start bronchoscopy when the nasal-oral capnography shows hypoventilation during bronchoscopic sedation. Receives: Device: A nasal-oral cannula of capnography |
| Sedation scale | Active comparator | Start bronchoscopy when Observer Assessment of Alertness and Sedation scale (OAAS)=3~2 during bronchoscopic sedation. Receives: Other: Observer Assessment of Alertness and Sedation scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Oxyhemoglobin saturation less than 90% with any duration after induction to patient recovery.
Measured: 60 minutes
Secondary outcomes (5)
Patient satisfaction
A 10cm visual analogue scale about how the patients fell about the bronchoscopy
Measured: 60 minutes
Patient cooperation accessed by bronchoscopists
A 10cm visual analogue scale about how the bronchoscopists fell the cooperation of patients during bronchoscopy.
Measured: 60 minutes
Induction time
The length of time for achieving adequate sedative depth to start bronchoscopy
Measured: 10 minutes
Procedure time
The length of time for complete bronchoscopy
Measured: 30 minutes
Propofol dosage
the dose of propofol for induction and whole bronchoscopy
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypoventilationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Lun Lo, Chang Gung Memorial Hospital
- Investigators
- Yu-Lun Lo, MD, Principal investigator, Chang Gung Medical fundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848118
- Sponsor's protocol ID
- 104-0872C
- Status last verified
- Mar 2017
- First submitted
- 18 Mar 2015
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 23638141Soto 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.
PubMed 15271710
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capnography Monitoring the Hypoventilation During Bronchoscopic Sedation
- ClinicalTrials.gov ID
- NCT02848118
- Acronym / sponsor ID
- 104-0872C
- Conditions
- Hypoventilation
- Keywords
- Hypoventilation, capnography, bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A nasal-oral cannula of capnography | Experimental | Device: A nasal-oral cannula of capnographyStart bronchoscopy when the nasal-oral capnography shows hypoventilation during bronchoscopic sedation. |
| Sedation scale | Active comparator | Other: Observer Assessment of Alertness and Sedation scaleStart bronchoscopy when Observer Assessment of Alertness and Sedation scale (OAAS)=3~2 during bronchoscopic sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective bronchoscopy and sedation
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A nasal-oral cannula of capnographyAlso: End-tidal CO2After propofol infusion, the complete induction is defined when capnography shows hypoventilation and bronchoscope is then introduced to patients. | Device | A nasal-oral cannula of capnography |
| Observer Assessment of Alertness and Sedation scaleAlso: OAASAfter propofol infusion, the complete induction is defined when OAAS is 3 to 2 (conscious sedation) and bronchoscope is then introduced to patients. | Other | Sedation scale |
Primary outcome
Hypoxemia
Time frame: 60 minutes
Oxyhemoglobin saturation less than 90% with any duration after induction to patient recovery.
5 secondary outcomes
Patient satisfaction
Time frame: 60 minutes
Patient cooperation accessed by bronchoscopists
Time frame: 60 minutes
Induction time
Time frame: 10 minutes
Procedure time
Time frame: 30 minutes
Propofol dosage
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Background: PubMed 23638141Lin 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.
- Background: PubMed 15271710Soto 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Lun Lo, MD principal investigator
Chang Gung Medical fundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A nasal-oral cannula of capnography and Observer Assessment of Alertness and Sedation scale in people with Hypoventilation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848118, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.