PEEP Influence on Gas Exchange During Early Weaning

NCT02281695 | Withdrawn

• 1 other identifier: MHO 001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

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

  30, 60, 90, 120, 360 Minutes

Study Arms (2)

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.

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.

Other: PEEP adjusment during the Weaning process

Interventions

PEEP adjusment during the Weaning process 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 A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marienhospital Osnabrück: lead

Study Sites (1)

Marienhospital Osnabrück

Osnabrück, Lower Saxony, 49074, Germany

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

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

  Marienhospital Osnabrück

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.D. dr. med. Martin Beiderlinden

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 3, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

DE (1)