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PEEP Influence on Gas Exchange During Early Weaning (MHOPEEP)

Primary Purpose

Respiratory Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PEEP adjusment during the Weaning process
Sponsored by
Marienhospital Osnabrück
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marienhospital Osnabrück

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in the Oxygen Partial Pressure and CO2 Partial Pressure in the arterial blood gas analysis

Secondary Outcome Measures

Full Information

First Posted
October 29, 2014
Last Updated
August 29, 2022
Sponsor
Marienhospital Osnabrück
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1. Study Identification

Unique Protocol Identification Number
NCT02281695
Brief Title
PEEP Influence on Gas Exchange During Early Weaning
Acronym
MHOPEEP
Official Title
The Influence of Different PEEP Values on Gas Exchange in Spontaneously Breathing Patients During Early Weaning
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawal of Primary investigators
Study Start Date
October 2014 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marienhospital Osnabrück

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PEEP adjusment during the Weaning process
Intervention Description
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 Measure Information:
Title
Changes in the Oxygen Partial Pressure and CO2 Partial Pressure in the arterial blood gas analysis
Time Frame
30, 60, 90, 120, 360 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Beiderlinden, P.D. dr. - med.
Organizational Affiliation
Marienhospital Osnabrück
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marienhospital Osnabrück
City
Osnabrück
State/Province
Niedersachsen
ZIP/Postal Code
49074
Country
Germany

12. IPD Sharing Statement

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PEEP Influence on Gas Exchange During Early Weaning

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