Conscious SedationNCT03886454
Incidence and Nature of Respiratory Impairment in Consecutive Patients Undergoing Bronchoscopy Under Conscious Sedation: A Pilot Study
An observational study of Conscious Sedation and Bronchoscopy, run by Tufts Medical Center at 1 site in United States.
Trial summary
This study aims to characterize airflow patterns during bronchoscopy under conscious sedation, and determine the incidence of obstructive and central respiratory events. The investigators also plan to monitor the degree and frequency of oxygen desaturation throughout the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conscious Sedation, Bronchoscopy
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 1 Jul 2019
- Phase
- Observational
- 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
Study population: All patients who have been referred to the pulmonary division at Tufts Medical Center for bronchoscopy
Who may be able to join
- Patients with respiratory pathology that require bronchoscopy for further diagnostic evaluation, as part of standard of care
- Age of 18 years or older.
- Our study does not include the recruitment of vulnerable populations such as cognitively impaired adults, pregnant women, pregnant minors, minors, wards of the state, non-viable neonates, neonates of uncertain viability and prisoners.
Who cannot join
- Oxygen requirement of more than 4 Liter prior to procedure.
- Intubation or any airway support.
- Presence of severe cardiopulmonary or neurologic disease as determined by the investigator.
- Nasal congestion/obstruction preventing proper placement and monitoring of air flow
- Inability to provide informed consent.
- All vulnerable population mentioned above.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to characterize airflow patterns during bronchoscopy under conscious sedation, and determine the incidence of obstructive and central respiratory events. The investigators also plan to monitor the degree and frequency of oxygen desaturation throughout the procedure. To achieve this, investigators use a physiologic monitoring device (NOX T3, K082113) that has been FDA approved for the screening and diagnosis of sleep disordered breathing [1]. The results from this pilot study will be used to assess the feasibility of a prospective study utilizing continuous external negative pressure (Pneuway). This negative pressure is applied through a neck mask to alleviate upper airway collapsibility and can potentially decrease the number of apneas during bronchoscopy under conscious sedation [2].
Read the detailed description
Background and Rationale:
Diagnostic bronchoscopic procedures are commonly performed in patients with various forms of pulmonary disorders associated with abnormal chest imaging. During these procedures, the vocal cords are intubated using a flexible scope. Patients need sedation and analgesia, and conscious sedation is typically administered. Hypoxemia is a potential complication during bronchoscopy. Contributing factors in addition to the underlying lung pathology, include depression of the respiratory center and decreased upper airway muscle tone that occur during conscious sedation [3]. Upper airway obstruction including obstructive apnea is often unrecognized during these procedures till hypoxemia is apparent [4]. Propofol, a common drug used for conscious sedation, is known to cause respiratory depression, and potentially central and/or obstructive apneas with a direct dose-response pattern [5]. Others, including benzodiazepines and opiates, can also cause respiratory depression leading to central or obstructive events. Respiratory depression is potentiated when any of the above medications are combined [6].
Objectives:
The objective of the study is to identify the incidence of airflow limitation during bronchoscopy under conscious sedation, and further characterize it as obstructive or central. The primary endpoint is the incidence of obstructive and central apneic events during bronchoscopic procedures. The secondary outcomes include incidence of oxygen desaturation and need for escalation of care.
Study Design:
After informed consent is obtained, the NOX-T3 monitoring system, a commonly used portable sleep device that detects obstructive and central apneas, is placed prior to starting the procedure, and remains in place up to 30 minutes following the procedure. The NOX-T3 monitoring system includes a nasal cannula that sits over the nares, an elastic band that goes around the chest, and another one that goes around the abdomen, and a finger probe that is placed on the index finger. All subjects undergo bronchoscopy with standard of care including the monitoring of blood pressure, respiratory rate and oxygen saturation. All subjects have the NOX-T3 applied in addition to standard of care monitoring. Data is assessed following the completion of the procedure. Subjects' participation in this study ends at the completion of their standard of care visit. All the NOX-T3 studies are scored and interpreted by study investigators.
Data Management:
This is an observational and descriptive study with an estimated sample size of 30. Data collected will be reviewed with a statistician and investigators will report on patients' demographics. The study investigators will also present the incidence of apneic respiratory events and characterize them as obstructive or centrals. Investigators will further differentiate obstructive respiratory events to either apneas or hypopnea. Data on oxygen desaturations unrelated to apneic events will also be recorded.
- Conditions
- Conscious Sedation, Bronchoscopy
- Keywords
- Central apnea, Obstructive apnea, Oxygen desaturation, Escalation of Care, conscious sedation, Bronchoscopy, Respiratory impairment
- Medical subject headings
- Sleep Apnea, Central, Sleep Apnea, Obstructive, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of obstructive and central apneic events.
Obstructive apnea are defined as more than 90% cessation of air-flow that lasts for at least 10 seconds, despite the presence of respiratory and abdominal muscle effort. Obstructive hypopnea is when more than 30% cessation of air-flow occurs that lasts for at least 10 seconds, and is associated with oxygen desaturation of at least 3% from baseline. Central apnea is when cessation of air-flow occurs secondary to absent respiratory and abdominal muscle effort, that lasts for at least 10 seconds.
Measured: Throughout the bronchoscopic procedure.
Secondary outcomes (2)
Oxygen desaturation
Oxygen desaturation of more than 3% from baseline which are unrelated to apneic events.
Measured: Throughout the bronchoscopic procedure.
Need for escalation of care
Need for escalation of care, including but not limited to, increasing supplemental oxygen, jaw thrust, patient stimulation or interrupting the administration of conscious sedation drug.
Measured: Throughout the bronchoscopic procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start19 Jun 2017
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Natalie V. Zucker Research Grant
- Responsible party
- Sponsor
- Investigators
- Khalid Ismail, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886454
- Sponsor's protocol ID
- IRB # 12489
- Status last verified
- Aug 2019
- First submitted
- 20 Mar 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Plan is to make IPD available to sommetrics Inc. to review once the study is complete. Data would include all the information obtained on the NOX-T3 device during conscious sedation which includes, but is not limited to, heart rate, respiratory rate, air flow through nasal cannula, oxygen saturation and chest and abdominal wall movements.
Publications
Cairns A, Wickwire E, Schaefer E, Nyanjom D. A pilot validation study for the NOX T3(TM) portable monitor for the detection of OSA. Sleep Breath. 2014 Sep;18(3):609-14. doi: 10.1007/s11325-013-0924-2. Epub 2014 Jan 19.
PubMed 24442914Kais SS, Klein KB, Rose RM, Endemann S, Coyle WJ. Continuous negative external pressure (cNEP) reduces respiratory impairment during screening colonoscopy: a pilot study. Endoscopy. 2016 Jun;48(6):584-7. doi: 10.1055/s-0042-102533. Epub 2016 Apr 25.
PubMed 27110692Hillman DR, Platt PR, Eastwood PR. The upper airway during anaesthesia. Br J Anaesth. 2003 Jul;91(1):31-9. doi: 10.1093/bja/aeg126.
PubMed 12821563Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208.
PubMed 12024135Eastwood PR, Platt PR, Shepherd K, Maddison K, Hillman DR. Collapsibility of the upper airway at different concentrations of propofol anesthesia. Anesthesiology. 2005 Sep;103(3):470-7. doi: 10.1097/00000542-200509000-00007.
PubMed 16129969Jose RJ, Shaefi S, Navani N. Sedation for flexible bronchoscopy: current and emerging evidence. Eur Respir Rev. 2013 Jun 1;22(128):106-16. doi: 10.1183/09059180.00006412.
PubMed 23728864
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Nature of Respiratory Impairment in Consecutive Patients Undergoing Bronchoscopy Under Conscious Sedation: A Pilot Study
- ClinicalTrials.gov ID
- NCT03886454
- Acronym / sponsor ID
- IRB # 12489
- Conditions
- Conscious Sedation, Bronchoscopy
- Keywords
- Central apnea, Obstructive apnea, Oxygen desaturation, Escalation of Care, conscious sedation, Bronchoscopy, Respiratory impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Natalie V. Zucker Research Grant
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 22 Mar 2019 (actual)
- 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.
This study aims to characterize airflow patterns during bronchoscopy under conscious sedation, and determine the incidence of obstructive and central respiratory events. The investigators also plan to monitor the degree and frequency of oxygen desaturation throughout the procedure. To achieve this, investigators use a physiologic monitoring device (NOX T3, K082113) that has been FDA approved for the screening and diagnosis of sleep disordered breathing [1]. The results from this pilot study will be used to assess the feasibility of a prospective study utilizing continuous external negative pressure (Pneuway). This negative pressure is applied through a neck mask to alleviate upper airway collapsibility and can potentially decrease the number of apneas during bronchoscopy under conscious sedation [2].
Detailed description
Background and Rationale:
Diagnostic bronchoscopic procedures are commonly performed in patients with various forms of pulmonary disorders associated with abnormal chest imaging. During these procedures, the vocal cords are intubated using a flexible scope. Patients need sedation and analgesia, and conscious sedation is typically administered. Hypoxemia is a potential complication during bronchoscopy. Contributing factors in addition to the underlying lung pathology, include depression of the respiratory center and decreased upper airway muscle tone that occur during conscious sedation [3]. Upper airway obstruction including obstructive apnea is often unrecognized during these procedures till hypoxemia is apparent [4]. Propofol, a common drug used for conscious sedation, is known to cause respiratory depression, and potentially central and/or obstructive apneas with a direct dose-response pattern [5]. Others, including benzodiazepines and opiates, can also cause respiratory depression leading to central or obstructive events. Respiratory depression is potentiated when any of the above medications are combined [6].
Objectives:
The objective of the study is to identify the incidence of airflow limitation during bronchoscopy under conscious sedation, and further characterize it as obstructive or central. The primary endpoint is the incidence of obstructive and central apneic events during bronchoscopic procedures. The secondary outcomes include incidence of oxygen desaturation and need for escalation of care.
Study Design:
After informed consent is obtained, the NOX-T3 monitoring system, a commonly used portable sleep device that detects obstructive and central apneas, is placed prior to starting the procedure, and remains in place up to 30 minutes following the procedure. The NOX-T3 monitoring system includes a nasal cannula that sits over the nares, an elastic band that goes around the chest, and another one that goes around the abdomen, and a finger probe that is placed on the index finger. All subjects undergo bronchoscopy with standard of care including the monitoring of blood pressure, respiratory rate and oxygen saturation. All subjects have the NOX-T3 applied in addition to standard of care monitoring. Data is assessed following the completion of the procedure. Subjects' participation in this study ends at the completion of their standard of care visit. All the NOX-T3 studies are scored and interpreted by study investigators.
Data Management:
This is an observational and descriptive study with an estimated sample size of 30. Data collected will be reviewed with a statistician and investigators will report on patients' demographics. The study investigators will also present the incidence of apneic respiratory events and characterize them as obstructive or centrals. Investigators will further differentiate obstructive respiratory events to either apneas or hypopnea. Data on oxygen desaturations unrelated to apneic events will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have been referred to the pulmonary division at Tufts Medical Center for bronchoscopy
Key inclusion criteria (3 listed)
- Patients with respiratory pathology that require bronchoscopy for further diagnostic evaluation, as part of standard of care
- Age of 18 years or older.
- Our study does not include the recruitment of vulnerable populations such as cognitively impaired adults, pregnant women, pregnant minors, minors, wards of the state, non-viable neonates, neonates of uncertain viability and prisoners.
Key exclusion criteria (6 listed)
- Oxygen requirement of more than 4 Liter prior to procedure.
- Intubation or any airway support.
- Presence of severe cardiopulmonary or neurologic disease as determined by the investigator.
- Nasal congestion/obstruction preventing proper placement and monitoring of air flow
- Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of obstructive and central apneic events.
Time frame: Throughout the bronchoscopic procedure.
Obstructive apnea are defined as more than 90% cessation of air-flow that lasts for at least 10 seconds, despite the presence of respiratory and abdominal muscle effort. Obstructive hypopnea is when more than 30% cessation of air-flow occurs that lasts for at least 10 seconds, and is associated with oxygen desaturation of at least 3% from baseline. Central apnea is when cessation of air-flow occurs secondary to absent respiratory and abdominal muscle effort, that lasts for at least 10 seconds.
2 secondary outcomes
Oxygen desaturation
Time frame: Throughout the bronchoscopic procedure.
Need for escalation of care
Time frame: Throughout the bronchoscopic procedure.
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 28 Aug 2019.
- Background: PubMed 24442914Cairns A, Wickwire E, Schaefer E, Nyanjom D. A pilot validation study for the NOX T3(TM) portable monitor for the detection of OSA. Sleep Breath. 2014 Sep;18(3):609-14. doi: 10.1007/s11325-013-0924-2. Epub 2014 Jan 19.
- Background: PubMed 27110692Kais SS, Klein KB, Rose RM, Endemann S, Coyle WJ. Continuous negative external pressure (cNEP) reduces respiratory impairment during screening colonoscopy: a pilot study. Endoscopy. 2016 Jun;48(6):584-7. doi: 10.1055/s-0042-102533. Epub 2016 Apr 25.
- Background: PubMed 12821563Hillman DR, Platt PR, Eastwood PR. The upper airway during anaesthesia. Br J Anaesth. 2003 Jul;91(1):31-9. doi: 10.1093/bja/aeg126.
- Background: PubMed 12024135Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208.
- Background: PubMed 16129969Eastwood PR, Platt PR, Shepherd K, Maddison K, Hillman DR. Collapsibility of the upper airway at different concentrations of propofol anesthesia. Anesthesiology. 2005 Sep;103(3):470-7. doi: 10.1097/00000542-200509000-00007.
- Background: PubMed 23728864Jose RJ, Shaefi S, Navani N. Sedation for flexible bronchoscopy: current and emerging evidence. Eur Respir Rev. 2013 Jun 1;22(128):106-16. doi: 10.1183/09059180.00006412.
- Individual participant dataSharing planned: Yes. Plan is to make IPD available to sommetrics Inc. to review once the study is complete. Data would include all the information obtained on the NOX-T3 device during conscious sedation which includes, but is not limited to, heart rate, respiratory rate, air flow through nasal cannula, oxygen saturation and chest and abdominal wall movements.
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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.
Khalid Ismail, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conscious Sedation and Bronchoscopy, run by Tufts Medical Center at 1 site in United States.
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 3 inclusion and 6 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 28 Aug 2019. 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 United States. 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?
The incidence of obstructive and central apneic events. (time frame: Throughout the bronchoscopic procedure.). 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 NCT03886454, which also lists 6 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 28 Aug 2019.