Respiratory FailureMHOPEEPNCT02281695
PEEP Influence on Gas Exchange During Early Weaning
A study testing PEEP adjusment during the Weaning process in people with Respiratory Failure, run by Marienhospital Osnabrück at 1 site in Germany.
Trial summary
The purpose of this study is to determine the differences in oxygenation and decarboxylation between two weaning processes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- PEEP adjusment during the Weaning process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Dec 2018
- 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
- All Patients that are mechanical ventilated on the intensive care unit.
Who cannot join
- Patients under 18 years of age
- Patients that where in an other study in the last 30 days
- Patients that are enrolled in other studies
- Pregnant woman
- Nursing mothers
- Existing severe Lung disease
- Existing COPD Gold IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Different PEEP Values on Gas Exchange in Spontaneously Breathing Patients During Early Weaning
The purpose of this study is to determine the differences in oxygenation and decarboxylation between two weaning processes.
Read the detailed description
First, during controlled mechanical ventilation all patients will be ventilated for 5 minutes with 100% oxygen. After 5 minutes an PaO2/FiO2 will be calculated and compared with a PaO2/FiO2 during ventilation with FiO2 - 30%.
The patients will be divided in two sections: Section A are the patients with less than 24 hours mechanical ventilation until weaning start. Section B are the patients with more than 24 hours until weaning start.
The patients in every section will be further divided in two groups. Group 1 will be weaned starting with a PEEP equal with P mean during BiPAP, Group 2 will be weaned starting with a PEEP equal with PEEP during BiPAP.
Further, the weaning will be conducted after an known algorithm. The differences in the oxygenation and decarboxylation will be measured after 30 and 120 Minutes for Group A and after 30, 120, 240, 360 Minutes for Group B.
- Conditions
- Respiratory Failure
- Being tested
- PEEP adjusment during the Weaning process
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP adjusment during the Weaning processOther
The PEEP will be adjusted after an previously established algorithm and the differences in the arterial blood oxygen partial pressure will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Patients that are mechanically ventilated for less than 24 hours until the weaning process can be started.
At the beginning of the weaning process the PEEP will be adjusted at a value equal with the PEEP during BiPAP (Group 1) and Pmean during BiPAP (Group 2) During controlled mechanical ventilation all patients will be for 5 minutes with FiO2 - 100% ventilated. The PaO2/FiO2 after 5 minutes ventilation with 100% oxygen will be compared with the PaO2/FiO2 during ventilation with 30% oxygen. Receives: Other: PEEP adjusment during the Weaning process |
| Arm B | Active comparator | Patients that are mechanically ventilated for more than 24 hours until the weaning process can be started. At the beginning of the weaning process the PEEP will be adjusted at a value equal with the PEEP during BiPAP (Group 1) and Pmean during BiPAP (Group 2) During controlled mechanical ventilation all patients will be for 5 minutes with FiO2 - 100% ventilated. The PaO2/FiO2 after 5 minutes ventilation with 100% oxygen will be compared with the PaO2/FiO2 during ventilation with 30% oxygen. Receives: Other: PEEP adjusment during the Weaning process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Oxygen Partial Pressure and CO2 Partial Pressure in the arterial blood gas analysis
Measured: 30, 60, 90, 120, 360 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2018
- Study completionDec 2018
Why it stopped: Withdrawal of Primary investigators
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marienhospital Osnabrück
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Studienarzt K2A, Marienhospital Osnabrück
- Investigators
- Martin Beiderlinden, P.D. dr. - med., Principal investigator, Marienhospital Osnabrück
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281695
- Sponsor's protocol ID
- MHO 001
- Acronym
- MHOPEEP
- Status last verified
- Aug 2022
- First submitted
- 29 Oct 2014
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different PEEP Values on Gas Exchange in Spontaneously Breathing Patients During Early Weaning
- ClinicalTrials.gov ID
- NCT02281695
- Acronym / sponsor ID
- MHOPEEP / MHO 001
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of Primary investigators
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marienhospital OsnabrückUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Nov 2014 (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 differences in oxygenation and decarboxylation between two weaning processes.
Detailed description
First, during controlled mechanical ventilation all patients will be ventilated for 5 minutes with 100% oxygen. After 5 minutes an PaO2/FiO2 will be calculated and compared with a PaO2/FiO2 during ventilation with FiO2 - 30%.
The patients will be divided in two sections: Section A are the patients with less than 24 hours mechanical ventilation until weaning start. Section B are the patients with more than 24 hours until weaning start.
The patients in every section will be further divided in two groups. Group 1 will be weaned starting with a PEEP equal with P mean during BiPAP, Group 2 will be weaned starting with a PEEP equal with PEEP during BiPAP.
Further, the weaning will be conducted after an known algorithm. The differences in the oxygenation and decarboxylation will be measured after 30 and 120 Minutes for Group A and after 30, 120, 240, 360 Minutes for Group B.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Other: PEEP adjusment during the Weaning processPatients that are mechanically ventilated for less than 24 hours until the weaning process can be started. At the beginning of the weaning process the PEEP will be adjusted at a value equal with the PEEP during BiPAP (Group 1) and Pmean during BiPAP (Group 2) During controlled mechanical ventilation all patients will be for 5 minutes with FiO2 - 100% ventilated. The PaO2/FiO2 after 5 minutes ventilation with 100% oxygen will be compared with the PaO2/FiO2 during ventilation with 30% oxygen. |
| Arm B | Active comparator | Other: PEEP adjusment during the Weaning processPatients that are mechanically ventilated for more than 24 hours until the weaning process can be started. At the beginning of the weaning process the PEEP will be adjusted at a value equal with the PEEP during BiPAP (Group 1) and Pmean during BiPAP (Group 2) During controlled mechanical ventilation all patients will be for 5 minutes with FiO2 - 100% ventilated. The PaO2/FiO2 after 5 minutes ventilation with 100% oxygen will be compared with the PaO2/FiO2 during ventilation with 30% oxygen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All Patients that are mechanical ventilated on the intensive care unit.
Key exclusion criteria (7 listed)
- Patients under 18 years of age
- Patients that where in an other study in the last 30 days
- Patients that are enrolled in other studies
- Pregnant woman
- Nursing mothers
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 |
|---|---|---|
| PEEP adjusment during the Weaning processThe PEEP will be adjusted after an previously established algorithm and the differences in the arterial blood oxygen partial pressure will be compared. | Other | Arm A, Arm B |
Primary outcome
Changes in the Oxygen Partial Pressure and CO2 Partial Pressure in the arterial blood gas analysis
Time frame: 30, 60, 90, 120, 360 Minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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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.
Martin Beiderlinden, P.D. dr. - med. principal investigator
Marienhospital Osnabrück
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP adjusment during the Weaning process in people with Respiratory Failure, run by Marienhospital Osnabrück 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 7 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: withdrawn, as of the sponsor's last update on 1 Sep 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in the Oxygen Partial Pressure and CO2 Partial Pressure in the arterial blood gas analysis (time frame: 30, 60, 90, 120, 360 Minutes). 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 1 Sep 2022.