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PEEP Influence on Gas Exchange During Early Weaning (MHOPEEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281695
Recruitment Status : Unknown
Verified March 2016 by Studienarzt K2A, Marienhospital Osnabrück.
Recruitment status was:  Recruiting
First Posted : November 2, 2014
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Studienarzt K2A, Marienhospital Osnabrück

Brief Summary:
The purpose of this study is to determine the differences in oxygenation and decarboxylation between two weaning processes.

Condition or disease Intervention/treatment Phase
Respiratory Failure Other: PEEP adjusment during the Weaning process Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Influence of Different PEEP Values on Gas Exchange in Spontaneously Breathing Patients During Early Weaning
Study Start Date : October 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: Arm A

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.

Other: PEEP adjusment during the Weaning process
The PEEP will be adjusted after an previously established algorithm and the differences in the arterial blood oxygen partial pressure will be compared.

Active Comparator: Arm B
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.
Other: PEEP adjusment during the Weaning process
The PEEP will be adjusted after an previously established algorithm and the differences in the arterial blood oxygen partial pressure will be compared.




Primary Outcome Measures :
  1. Changes in the Oxygen Partial Pressure and CO2 Partial Pressure in the arterial blood gas analysis [ Time Frame: 30, 60, 90, 120, 360 Minutes ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Patients that are mechanical ventilated on the intensive care unit.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281695


Locations
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Germany
Marienhospital Osnabrück Recruiting
Osnabrück, Niedersachsen, Germany, 49074
Contact: Martin Beiderlinden, P.D. dr. - med.    0541 / 326 4502 ext 40    anaesthesiologie@mho.de   
Contact: Thorsten Heuter, dr. - med.    0541 / 326 8358 ext 40    thorsten.heuter@mho.de   
Principal Investigator: Romulus - Ovidiu Moldovean         
Principal Investigator: Sarah Kollmeyer         
Sponsors and Collaborators
Marienhospital Osnabrück
Investigators
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Principal Investigator: Martin Beiderlinden, P.D. dr. - med. Marienhospital Osnabrück
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Responsible Party: Studienarzt K2A, P.D. dr. med. Martin Beiderlinden, Marienhospital Osnabrück
ClinicalTrials.gov Identifier: NCT02281695    
Other Study ID Numbers: MHO 001
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases