Continuous Positive Airway PressureNAPTIMENCT06168682
Nasal CPAP - The Treatment IMpact on Oxygenation in High-risk Patients During Deep Sedation for Endoscopy
A study testing SuperNO2VA™ Et by Vyaire Medical, Inc. and nasal oxygen cannula in people with Continuous Positive Airway Pressure and Endoscopy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Deep sedation during gastrointestinal endoscopy in patients with cardiopulmonary risk factors such as respective co-morbidities or also morbid obesity is challenging. Those high-risk patients are at risk of upper airway obstruction and hypoxemia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Continuous Positive Airway Pressure, Endoscopy, Oxygenation
- What is being tested?
- SuperNO2VA™ Et by Vyaire Medical, Inc. and nasal oxygen cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2023to 30 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult and obese high-risk patients (ASA class ≥3 and/or BMI ≥30 kg/m², in accordance with the current WHO definition of obesity) scheduled for elective gastrointestinal endoscopy with deep sedation.
Who cannot join
- Age < 18 years
- Pregnancy
- Cognitive impairment, that makes consent to study impossible
- Known but untreated heart disease (e.g. persistent foramen ovale (PFO), recent congestive heart failure), complicating comparability within groups
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine
Hamburg, 20246
About this study
Official title: The Effect of Nasal Continuous Positive Airway Pressure on Oxygenation in High-risk Patients Having Gastrointestinal Endoscopy Under Deep Sedation
Deep sedation during gastrointestinal endoscopy in patients with cardiopulmonary risk factors such as respective co-morbidities or also morbid obesity is challenging. Those high-risk patients are at risk of upper airway obstruction and hypoxemia. Nasal continuous positive airway pressure may help to decrease the incidence of peri-interventional hypoxemia. However, data on nasal continuous positive airway pressure in high-risk patients having gastrointestinal endoscopy are scarce; only one randomized trial on gastroscopy in obese patients is available (Kang et al. J Anesth 2021). In a very high-risk group, namely patients assessed for heart or lung transplantation in our hospital, the risk was especially high (unpublished data).
Aim of this trial is the effect of nasal continuous positive airway pressure - compared to nasal oxygen insufflation - on the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation.
The investigators hypothesize that nasal continuous positive airway pressure - compared to nasal oxygen insufflation - reduces the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation.
Read the detailed description
High risk patients were defined as American Society of Anaesthesiology (ASA) class >3 and/or BMI ≥30 kg/m², in accordance with the current World Health Organization (WHO) definition of obesity scheduled for elective gastrointestinal endoscopy with deep sedation.
The main objective was investigating the incidences of hypoxemia defined as a peripheral oxygen saturation of ≤90% registered with the monitoring system of our working station (company: Masimo; type: Root) after inducing deep sedation while under endoscopy intervention. Secondary outcomes such as the duration of the whole intervention, the duration of hypoxemia or the incidence of need for airway interventions will also be investigated.
Patients will be randomized and divided into nCPAP group and nasal oxygenation insufflation group.
Depending on the type of endoscopy a positive airway pressure between 3 and 10 cmH20 can be generated with the nCPAP mask using an oxygenflow rate of 6l/min.
Deep sedation will be performed under surveillance of an anaesthesia team using only propofol bolus adjusted to predicted body weight (PBW)(1mg/kg) followed by continuous infusion of 4mg/kg/h adjusted to lean body weight (LBW), which is described by MacDonald et al. (doi: 10.1177/1751143714565059) as :
PBW (m) (kg) = 50 + [0.91 ×(Height in cm - 152.4) PBW (f) (kg) = 45,5 + [0.91 ×(Height in cm - 152.4)
Ideal body weight (IBW) (m) (kg) = 50 + [0.9 ×(Height in cm - 154) IBW (f) (kg) = 45,5 + [0.9 ×(Height in cm - 154)
Adjusted Body Weight (ABW): IBW+0,4* (Absoluteweight-IBW)
LBW (m) (kg) = (9270 x TBW) / (6680+(216 x BMI) LBW (f) (kg) = (9270 x TBW) / (8780+(244 x BMI)
The level of sedation will be evaluated using the MOAA/S Score (modified observer's assessment of alertness/sedation scale) described by Kowalski et al. (DOI:10.1097/00003643-200706001-00097).
The sample size calculation is based on the primary outcome of the incidence of hypoxemia defined as a peripheral oxygen saturation of ≤90% after inducing deep sedation while performing endoscopy.
The incidence of the primary outcome was assumed to be 30% in nasal oxygen insufflation group and 10% in the nasal continuous positive airway pressure group. A total sample size of 158, i.e., 79 patients per group, is required to achieve 90% power in the detection of a difference of 20% between the group incidences at a significance level of 0.05 using a two-sided test of proportions. The randomization and division in subgroup "nasal continuous positive airway pressure" and "nasal oxygen insufflation" will occur prior to study entry. The entire collective will be divided into 2 populations and the allocation sealed in envelopes. The envelope will only be opened directly before the study so that investigator bias can be minimized.
- Conditions
- Continuous Positive Airway Pressure, Endoscopy, Oxygenation, Obesity
- Being tested
- SuperNO2VA™ Et by Vyaire Medical, Inc., nasal oxygen cannula
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperNO2VA™ Et by Vyaire Medical, Inc.Device
SuperNO2VA™ Et provides a nCPAP between 3 to 10 cmH20 using a oxygenflowrate of 6l/O2
nasal oxygen cannulaDevice
Standard Operating Procedure (SOP) for endoscopy: Using a nasal oxygen cannula with oxygenflowrate of 6l/O2
| Study group | Role | What they receive |
|---|---|---|
| nasal continuous positive airway pressure | Experimental | nasal continuous positive airway pressure (3-10cmH20) administered with 6 l/O2 with the SuperNO2VA™ Et produced by Vyaire Medical, Inc. Receives: Device: SuperNO2VA™ Et by Vyaire Medical, Inc. |
| nasal oxygen insufflation | Active comparator | nasal oxygen insufflation with 6 l/02 will be administered as control-group/standard intervention for endoscopy Receives: Device: nasal oxygen cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
hypoxemia is defined as a peripheral oxygen saturation of ≤90% registered with the monitoring system of our working station (Phillips IntelliVue and Massimo Rad-97) after inducing deep sedation while under endoscopy intervention.
Measured: Time between Induction of deep sedation and end of procedure (endoscopy)
Secondary outcomes (7)
Duration of intervention
Total time (sec)
Measured: Time between Induction of deep sedation and end of procedure (endoscopy)
Duration of hypoxemia
Time between hypoxemia (<90% SpO2) and recovery (> 90% SpO2) (sec)
Measured: Time between Induction of deep sedation and end of procedure (endoscopy)
Hypoxemic events
Number of hypoxemic events per intervention/endoscopy
Measured: Time between Induction of deep sedation and end of procedure (endoscopy)
hypoxemia duration to procedure duration
Relative ratio of hypoxemia duration compared to procedure duration
Measured: Time between Induction of deep sedation and end of procedure (endoscopy)
Airway intervention
Incidence of airwayintervention (mask ventilation, intubation, interruption)
Measured: Time between Induction of deep sedation and end of procedure (endoscopy)
Sedation score
Modified observer's assessment of Alertness / Sedation (MOAA/S)
Measured: Time between Induction of deep sedation and end of procedure (endoscopy)
Endtidal CO2 (carbon dioxide)
Continuous measurement of endtidal CO2 via the mask
Measured: Time between Induction of deep sedation and end of procedure (endoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Nov 2023
- Primary completion30 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Continuous Positive Airway PressureStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized single centre trial
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karlo R Huenerbein, Dr. med., Principal investigator, Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168682
- Sponsor's protocol ID
- 14116209135
- Acronym
- NAPTIME
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hunerbein K, Sprenger C, Zollner C, de Heer J, von Wulffen M, Zimmermann K, Rosch T, Issleib M. Nasal Continuous Positive Airway Pressure to Reduce Hypoxia in Patients With Obesity Undergoing Sedated Upper Gastrointestinal Endoscopy: A Prospective Randomized Trial. Clin Gastroenterol Hepatol. 2026 Jan;24(1):113-120.e4. doi: 10.1016/j.cgh.2025.06.015. Epub 2025 Jul 1.
PubMed 40609816
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nasal Continuous Positive Airway Pressure on Oxygenation in High-risk Patients Having Gastrointestinal Endoscopy Under Deep Sedation
- ClinicalTrials.gov ID
- NCT06168682
- Acronym / sponsor ID
- NAPTIME / 14116209135
- Conditions
- Continuous Positive Airway Pressure, Endoscopy, Oxygenation, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Dec 2023 (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.
Deep sedation during gastrointestinal endoscopy in patients with cardiopulmonary risk factors such as respective co-morbidities or also morbid obesity is challenging. Those high-risk patients are at risk of upper airway obstruction and hypoxemia. Nasal continuous positive airway pressure may help to decrease the incidence of peri-interventional hypoxemia. However, data on nasal continuous positive airway pressure in high-risk patients having gastrointestinal endoscopy are scarce; only one randomized trial on gastroscopy in obese patients is available (Kang et al. J Anesth 2021). In a very high-risk group, namely patients assessed for heart or lung transplantation in our hospital, the risk was especially high (unpublished data).
Aim of this trial is the effect of nasal continuous positive airway pressure - compared to nasal oxygen insufflation - on the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation.
The investigators hypothesize that nasal continuous positive airway pressure - compared to nasal oxygen insufflation - reduces the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation.
Detailed description
High risk patients were defined as American Society of Anaesthesiology (ASA) class >3 and/or BMI ≥30 kg/m², in accordance with the current World Health Organization (WHO) definition of obesity scheduled for elective gastrointestinal endoscopy with deep sedation.
The main objective was investigating the incidences of hypoxemia defined as a peripheral oxygen saturation of ≤90% registered with the monitoring system of our working station (company: Masimo; type: Root) after inducing deep sedation while under endoscopy intervention. Secondary outcomes such as the duration of the whole intervention, the duration of hypoxemia or the incidence of need for airway interventions will also be investigated.
Patients will be randomized and divided into nCPAP group and nasal oxygenation insufflation group.
Depending on the type of endoscopy a positive airway pressure between 3 and 10 cmH20 can be generated with the nCPAP mask using an oxygenflow rate of 6l/min.
Deep sedation will be performed under surveillance of an anaesthesia team using only propofol bolus adjusted to predicted body weight (PBW)(1mg/kg) followed by continuous infusion of 4mg/kg/h adjusted to lean body weight (LBW), which is described by MacDonald et al. (doi: 10.1177/1751143714565059) as :
PBW (m) (kg) = 50 + [0.91 ×(Height in cm - 152.4) PBW (f) (kg) = 45,5 + [0.91 ×(Height in cm - 152.4)
Ideal body weight (IBW) (m) (kg) = 50 + [0.9 ×(Height in cm - 154) IBW (f) (kg) = 45,5 + [0.9 ×(Height in cm - 154)
Adjusted Body Weight (ABW): IBW+0,4* (Absoluteweight-IBW)
LBW (m) (kg) = (9270 x TBW) / (6680+(216 x BMI) LBW (f) (kg) = (9270 x TBW) / (8780+(244 x BMI)
The level of sedation will be evaluated using the MOAA/S Score (modified observer's assessment of alertness/sedation scale) described by Kowalski et al. (DOI:10.1097/00003643-200706001-00097).
The sample size calculation is based on the primary outcome of the incidence of hypoxemia defined as a peripheral oxygen saturation of ≤90% after inducing deep sedation while performing endoscopy.
The incidence of the primary outcome was assumed to be 30% in nasal oxygen insufflation group and 10% in the nasal continuous positive airway pressure group. A total sample size of 158, i.e., 79 patients per group, is required to achieve 90% power in the detection of a difference of 20% between the group incidences at a significance level of 0.05 using a two-sided test of proportions. The randomization and division in subgroup "nasal continuous positive airway pressure" and "nasal oxygen insufflation" will occur prior to study entry. The entire collective will be divided into 2 populations and the allocation sealed in envelopes. The envelope will only be opened directly before the study so that investigator bias can be minimized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized single centre trial
| Arm | Type | Receives |
|---|---|---|
| nasal continuous positive airway pressure | Experimental | Device: SuperNO2VA™ Et by Vyaire Medical, Inc.nasal continuous positive airway pressure (3-10cmH20) administered with 6 l/O2 with the SuperNO2VA™ Et produced by Vyaire Medical, Inc. |
| nasal oxygen insufflation | Active comparator | Device: nasal oxygen cannulanasal oxygen insufflation with 6 l/02 will be administered as control-group/standard intervention for endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult and obese high-risk patients (ASA class ≥3 and/or BMI ≥30 kg/m², in accordance with the current WHO definition of obesity) scheduled for elective gastrointestinal endoscopy with deep sedation.
Key exclusion criteria (4 listed)
- Age < 18 years
- Pregnancy
- Cognitive impairment, that makes consent to study impossible
- Known but untreated heart disease (e.g. persistent foramen ovale (PFO), recent congestive heart failure), complicating comparability within groups
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 |
|---|---|---|
| SuperNO2VA™ Et by Vyaire Medical, Inc.SuperNO2VA™ Et provides a nCPAP between 3 to 10 cmH20 using a oxygenflowrate of 6l/O2 | Device | nasal continuous positive airway pressure |
| nasal oxygen cannulaStandard Operating Procedure (SOP) for endoscopy: Using a nasal oxygen cannula with oxygenflowrate of 6l/O2 | Device | nasal oxygen insufflation |
Primary outcome
Incidence of hypoxemia
Time frame: Time between Induction of deep sedation and end of procedure (endoscopy)
hypoxemia is defined as a peripheral oxygen saturation of ≤90% registered with the monitoring system of our working station (Phillips IntelliVue and Massimo Rad-97) after inducing deep sedation while under endoscopy intervention.
7 secondary outcomes
Duration of intervention
Time frame: Time between Induction of deep sedation and end of procedure (endoscopy)
Duration of hypoxemia
Time frame: Time between Induction of deep sedation and end of procedure (endoscopy)
Hypoxemic events
Time frame: Time between Induction of deep sedation and end of procedure (endoscopy)
hypoxemia duration to procedure duration
Time frame: Time between Induction of deep sedation and end of procedure (endoscopy)
Airway intervention
Time frame: Time between Induction of deep sedation and end of procedure (endoscopy)
Sedation score
Time frame: Time between Induction of deep sedation and end of procedure (endoscopy)
Endtidal CO2 (carbon dioxide)
Time frame: Time between Induction of deep sedation and end of procedure (endoscopy)
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 Dec 2024.
- Derived from this study: PubMed 40609816Hunerbein K, Sprenger C, Zollner C, de Heer J, von Wulffen M, Zimmermann K, Rosch T, Issleib M. Nasal Continuous Positive Airway Pressure to Reduce Hypoxia in Patients With Obesity Undergoing Sedated Upper Gastrointestinal Endoscopy: A Prospective Randomized Trial. Clin Gastroenterol Hepatol. 2026 Jan;24(1):113-120.e4. doi: 10.1016/j.cgh.2025.06.015. Epub 2025 Jul 1.
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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.
Karlo R Huenerbein, Dr. med. principal investigator
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperNO2VA™ Et by Vyaire Medical, Inc. and nasal oxygen cannula in people with Continuous Positive Airway Pressure and Endoscopy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 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 Dec 2024. 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 Germany. 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?
Incidence of hypoxemia (time frame: Time between Induction of deep sedation and end of procedure (endoscopy)). 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 NCT06168682, which also lists 1 linked publication.
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 Dec 2024.