HypercapniaEndo-BreathNCT05972304
Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy
A study testing Nasal positive airway System by Vyaire Medical in people with Hypercapnia and Hypoxia, run by University of Ulm at 1 site in Germany.
Trial summary
Goal of our study is to investigate whether the implication of nasal positive airway pressure (nPAP) system on patients with high periprocedural risk could significantly lower the incidence of severe hypoxia and hypercarbia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnia, Hypoxia
- What is being tested?
- Nasal positive airway System by Vyaire Medical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2022to 1 Dec 2022
- 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
- ASA III (poorly controlled Diabetes Melitus (DM) or arterial hypertension (HTN), Chronic obstructive Pulmonary Disease (COPD), morbid obesity (BMI≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, End Stage Renal Disease (ESRD), Advanced Liver Disease ( ACLD) ; history (>3 months) of Myocardial Infarction, coronary artery disease (CAD) , transient ischemic attack (TIA), or CAD/stents)
- ASA IV (recent (<3 months MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, ARD or ESRD not undergoing regularly scheduled dialysis
- Active Malignancy (ECOG Performance >2)
Who cannot join
- Patients with tracheotomy
- Pregnancy
- Intubation assisted endoscopy
- Procedure without sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopic Procedures in High Risk Patients. Endo-Breath-Study
Goal of our study is to investigate whether the implication of nasal positive airway pressure (nPAP) system on patients with high periprocedural risk could significantly lower the incidence of severe hypoxia and hypercarbia. Furthermore, we have set up goals to assess key components and factors, which lead to development of hypercarbia during endoscopy.
Read the detailed description
Sedation of high-risk patients resemble a relevant issue in interventional endoscopy.
This especially because standard oximetric monitoring displays only hypoxia and not the preceding hypercapnia. Therefore, the question arises whether the implication of a nasal positive airway pressure (nPAP) system can decrease the rate of sedation associated events.
The Null Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system, in comparison to control group with conventional oxygen supplementation canula is not significant.
Alternative Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system is significantly lower, than in a control group with conventional oxygen supplementation canula
- Conditions
- Hypercapnia, Hypoxia
- Being tested
- Nasal positive airway System by Vyaire Medical
- Medical subject headings
- Hypercapnia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal positive airway System by Vyaire MedicalDevice
Also called Superno2Va, Radiometer TCM 5
Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute). Receives: Device: Nasal positive airway System by Vyaire Medical |
| Control Group | No intervention | Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure
Measured: During endoscopic procedure
Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure
Measured: During endoscopic procedure
Secondary outcomes (4)
Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups
Delta tcpCO2 is the difference of tpCO2 values from the beginning of the intervention to the mean tpCO2 levels observed throughout the procedure, between two groups
Measured: During endoscopic procedure
Number of desaturation episodes (SpO2 < 90%)
Measured: During endoscopic procedure
Interception of the intervention due to insufficient oxygenation
Measured: During endoscopic procedure
The emmergence of serious adverse events
Measured: During endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Apr 2022
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercapniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Seufferlein, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972304
- Sponsor's protocol ID
- EndoBreath
- Acronym
- Endo-Breath
- Status last verified
- Jul 2023
- First submitted
- 29 Dec 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopic Procedures in High Risk Patients. Endo-Breath-Study
- ClinicalTrials.gov ID
- NCT05972304
- Acronym / sponsor ID
- Endo-Breath / EndoBreath
- Conditions
- Hypercapnia, Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 2 Aug 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.
Goal of our study is to investigate whether the implication of nasal positive airway pressure (nPAP) system on patients with high periprocedural risk could significantly lower the incidence of severe hypoxia and hypercarbia. Furthermore, we have set up goals to assess key components and factors, which lead to development of hypercarbia during endoscopy.
Detailed description
Sedation of high-risk patients resemble a relevant issue in interventional endoscopy.
This especially because standard oximetric monitoring displays only hypoxia and not the preceding hypercapnia. Therefore, the question arises whether the implication of a nasal positive airway pressure (nPAP) system can decrease the rate of sedation associated events.
The Null Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system, in comparison to control group with conventional oxygen supplementation canula is not significant.
Alternative Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system is significantly lower, than in a control group with conventional oxygen supplementation canula
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Nasal positive airway System by Vyaire MedicalPatients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute). |
| Control Group | No intervention | –Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA III (poorly controlled Diabetes Melitus (DM) or arterial hypertension (HTN), Chronic obstructive Pulmonary Disease (COPD), morbid obesity (BMI≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, End Stage Renal Disease (ESRD), Advanced Liver Disease ( ACLD) ; history (>3 months) of Myocardial Infarction, coronary artery disease (CAD) , transient ischemic attack (TIA), or CAD/stents)
- ASA IV (recent (<3 months MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, ARD or ESRD not undergoing regularly scheduled dialysis
- Active Malignancy (ECOG Performance >2)
Key exclusion criteria (4 listed)
- Patients with tracheotomy
- Pregnancy
- Intubation assisted endoscopy
- Procedure without sedation
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 |
|---|---|---|
| Nasal positive airway System by Vyaire MedicalAlso: Superno2Va, Radiometer TCM 5Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor | Device | Intervention Group |
Primary outcome
Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure
Time frame: During endoscopic procedure
Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure
Time frame: During endoscopic procedure
4 secondary outcomes
Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups
Time frame: During endoscopic procedure
Number of desaturation episodes (SpO2 < 90%)
Time frame: During endoscopic procedure
Interception of the intervention due to insufficient oxygenation
Time frame: During endoscopic procedure
The emmergence of serious adverse events
Time frame: During endoscopic 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 2 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal positive airway System by Vyaire Medical in people with Hypercapnia and Hypoxia, run by University of Ulm 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 3 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 2 Aug 2023. 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 Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure (time frame: During endoscopic procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2023.