PEEP Influence on Gas Exchange During Early Weaning

NCT ID: NCT02281695

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

PEEP adjusment during the Weaning process

Intervention Type OTHER

The PEEP will be adjusted after an previously established algorithm and the differences in the arterial blood oxygen partial pressure will be compared.

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.

Group Type ACTIVE_COMPARATOR

PEEP adjusment during the Weaning process

Intervention Type OTHER

The PEEP will be adjusted after an previously established algorithm and the differences in the arterial blood oxygen partial pressure will be compared.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marienhospital Osnabrück

OTHER

Sponsor Role lead

Responsible Party

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Studienarzt K2A

P.D. dr. med. Martin Beiderlinden

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Beiderlinden, P.D. dr. - med.

Role: PRINCIPAL_INVESTIGATOR

Marienhospital Osnabrück

Locations

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Marienhospital Osnabrück

Osnabrück, Lower Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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MHO 001

Identifier Type: -

Identifier Source: org_study_id

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