Sedation ProblemsPACSONCT02001792
Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome
A study testing Position the patient during colonoscopy and pulse oximeter in people with Sedation Problems and Breathing Complications, run by Technical University of Munich at 2 sites in Germany.
Trial summary
The purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sedation Problems, Breathing Complications
- What is being tested?
- Position the patient during colonoscopy and pulse oximeter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 412 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2012to Nov 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colonoscopy indicated
Who cannot join
- patient denies sedation
- prior saturation < 90%
- prior heart rate < 50 bpm
- prior blood pressure < 90 mmHg
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Endoscopy Section, Department for Internal Medicine and Gastroenterology, Technical University Munich
Munich, Bavaria, 81675
Krankenhaus Prien
Prien am Chiemsee, Bavaria
About this study
The purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome.
Read the detailed description
Sedative drugs are widely-used during endoscopic procedures. The administration of these drugs contain the potential hazard of breathing and cardiac complications. Moreover it is well-known that the dorsal position is in some ways associated to breathing problems while patients are asleep. We assume this also to be true related to short anesthesia during colonoscopy. Patient positioning may therefore have a positive effect on the safety during colonoscopy by reducing the absolute time that sedated patients spend in a supine position. We compiled a randomized trial which compares the appearance of breathing and cardiovascular complications by performing colonoscopy either in a dorsal or in a left lateral position.
- Conditions
- Sedation Problems, Breathing Complications
- Being tested
- Position the patient during colonoscopy, pulse oximeter
- Keywords
- sedation, endoscopy, patient positioning, hypoxemia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position the patient during colonoscopyProcedure or surgery
Position the patient either in a left lateral position during colonoscopy
pulse oximeterDevice
| Study group | Role | What they receive |
|---|---|---|
| Controll group | Sham comparator | Patients lying in a supine position during colonoscopy Receives: Device: pulse oximeter |
| Intervention | Active comparator | Patients lying in a left lateral position during colonoscopy Receives: Procedure: Position the patient during colonoscopy; Device: pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy
saturation and heart rate will be measured continuously, blood pressure will be measures all 3 minutes
Measured: participants will be followed for the duration of colonoscopy during hospital stay an expected average of 1 hour
Secondary outcomes (1)
Adenoma detection rate
Adenoma detection rate between the two arms will be compared at the end of the investigation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startApr 2012
- Primary completionFeb 2014
- Study completionNov 2014
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 Sedation ProblemsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Klare, MD, Principal investigator, Departmet for Internal Medicine and Gastroenterology, Technical University Munich, GermanyStefan von Delius, PD MD, Study director, Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001792
- Sponsor's protocol ID
- PatPo2012
- Acronym
- PACSO
- Status last verified
- Nov 2014
- First submitted
- 14 Apr 2012
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Klare P, Huth R, Haller B, Huth M, Weber A, Schlag C, Reindl W, Schmid RM, von Delius S. Patient position and hypoxemia during propofol sedation for colonoscopy: a randomized trial. Endoscopy. 2015 Dec;47(12):1159-66. doi: 10.1055/s-0034-1392329. Epub 2015 Jun 30.
PubMed 26126161
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome
- ClinicalTrials.gov ID
- NCT02001792
- Acronym / sponsor ID
- PACSO / PatPo2012
- Conditions
- Sedation Problems, Breathing Complications
- Keywords
- sedation, endoscopy, patient positioning, hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Dec 2013 (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.
The purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome.
Detailed description
Sedative drugs are widely-used during endoscopic procedures. The administration of these drugs contain the potential hazard of breathing and cardiac complications. Moreover it is well-known that the dorsal position is in some ways associated to breathing problems while patients are asleep. We assume this also to be true related to short anesthesia during colonoscopy. Patient positioning may therefore have a positive effect on the safety during colonoscopy by reducing the absolute time that sedated patients spend in a supine position. We compiled a randomized trial which compares the appearance of breathing and cardiovascular complications by performing colonoscopy either in a dorsal or in a left lateral position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controll group | Sham comparator | Device: pulse oximeterPatients lying in a supine position during colonoscopy |
| Intervention | Active comparator | Procedure: Position the patient during colonoscopy, Device: pulse oximeterPatients lying in a left lateral position during colonoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- colonoscopy indicated
Key exclusion criteria (4 listed)
- patient denies sedation
- prior saturation < 90%
- prior heart rate < 50 bpm
- prior blood pressure < 90 mmHg
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 |
|---|---|---|
| Position the patient during colonoscopyPosition the patient either in a left lateral position during colonoscopy | Procedure or surgery | Intervention |
| pulse oximeter | Device | Controll group, Intervention |
Primary outcome
frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy
Time frame: participants will be followed for the duration of colonoscopy during hospital stay an expected average of 1 hour
saturation and heart rate will be measured continuously, blood pressure will be measures all 3 minutes
1 secondary outcome
Adenoma detection rate
Time frame: 1 day
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 14 Nov 2014.
- Derived from this study: PubMed 26126161Klare P, Huth R, Haller B, Huth M, Weber A, Schlag C, Reindl W, Schmid RM, von Delius S. Patient position and hypoxemia during propofol sedation for colonoscopy: a randomized trial. Endoscopy. 2015 Dec;47(12):1159-66. doi: 10.1055/s-0034-1392329. Epub 2015 Jun 30.
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.
Peter Klare, MD principal investigator
Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany
Stefan von Delius, PD MD study director
Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position the patient during colonoscopy and pulse oximeter in people with Sedation Problems and Breathing Complications, run by Technical University of Munich at 2 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 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 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy (time frame: participants will be followed for the duration of colonoscopy during hospital stay an expected average of 1 hour). 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 NCT02001792, 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 14 Nov 2014.