In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated.Phase 3PEGNCT01242358
Capnography During Percutaneous Endoscopic Gastrostomy (PEG)
A Phase 3 study testing Capnography and Standard monitoring in people with In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated., run by Ruhr University of Bochum at 3 sites in Germany.
Trial summary
In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated.
- What is being tested?
- Capnography and Standard monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 3 sitesGermany
- Study dates
- Jun 2010to Mar 2012
- Phase
- Phase 3
- 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
- 18 Years and older
- Scheduled for PEG with propofol sedation
Who cannot join
- No informed consent
- ASA V
- Emergency endoscopy
- Preexisting hypotension, bradycardia or hypoxemia
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Ruhr Universität Bochum
Bochum, 44892
Andrea Riphaus, MD, +49-234-299 ext. 80200, ariphaus@web.de
Andrea Riphaus, MD
- Recruiting
Technische Universität München
München, 81675
Stefan von Delius,, MD
Stefan von Delius, MD
- Recruiting
Deutsche Klinik für Diagnostik
Wiesbaden, 65191
Till Wehrmann, Prof.
Till Wehrmann, Prof.
About this study
Official title: Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.
In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.
- Being tested
- Capnography, Standard monitoring
- Keywords
- hypoxaemia - capnography - integrated pulmonary index - PEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapnographyDevice
Capnographic monitoring
Standard monitoringDevice
Standard monitoring
| Study group | Role | What they receive |
|---|---|---|
| Capnography | Experimental | Arm with capnographic monitoring Receives: Device: Capnography |
| Standard monitoring | Placebo comparator | Standard monitoring Receives: Device: Standard monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Measured: From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h
Secondary outcomes (1)
Further complications
Measured: From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
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 In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated.Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Riphaus, Ruhr University of Bochum
- Investigators
- Andrea Riphaus, MD, Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242358
- Sponsor's protocol ID
- Capno-PEG 2010
- Acronym
- PEG
- Status last verified
- Nov 2011
- First submitted
- 16 Nov 2010
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Vargo 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 12024135
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.
- ClinicalTrials.gov ID
- NCT01242358
- Acronym / sponsor ID
- PEG / Capno-PEG 2010
- Keywords
- hypoxaemia - capnography - integrated pulmonary index - PEG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 17 Nov 2010 (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.
In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capnography | Experimental | Device: CapnographyArm with capnographic monitoring |
| Standard monitoring | Placebo comparator | Device: Standard monitoringStandard monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 Years and older
- Scheduled for PEG with propofol sedation
Key exclusion criteria (4 listed)
- No informed consent
- ASA V
- Emergency endoscopy
- Preexisting hypotension, bradycardia or hypoxemia
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 |
|---|---|---|
| CapnographyCapnographic monitoring | Device | Capnography |
| Standard monitoringStandard monitoring | Device | Standard monitoring |
Primary outcome
Hypoxemia
Time frame: From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h
1 secondary outcome
Further complications
Time frame: From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Results publication: 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.
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.
Andrea Riphaus, MD principal investigator
Ruhr University of Bochum
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capnography and Standard monitoring in people with In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated., run by Ruhr University of Bochum at 3 sites 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 2 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: status not confirmed, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Riphaus, MD (+49-234-299 ext. 80200, ariphaus@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h). 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 NCT01242358, 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 22 Nov 2011.