NCT04435535

Brief Summary

Positive expiratory pressure (PEP) breathing is common for treatment of different lung diseases and can increase lung volume and increase elimination of secretion from the airways. Today there is no evidence whether the treatment is effective or not for patients in the intensive care unit. The purpose of this study is to evaluate if PEP breathing can increase oxygenation for patients in the intensive care unit during weaning from the ventilator after acute respiratory distress syndrome. PEP breathing will be applied on the tracheal cannula for 15 minutes. Measure of the PEP effect will be done before, during and for 20 minutes after PEP breathing.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

5.2 years

First QC Date

June 2, 2020

Last Update Submit

June 14, 2020

Conditions

Acute Respiratory Distress Syndrome

Keywords

Breathing exercisesIntensive carePhysical therapy modalitiesPhysiotherapyRespiratory distress syndrome, adultVentilator weaning

Outcome Measures

Primary Outcomes (1)

  • Change in PaO2

    Change from baseline arterial partial pressure of oxygen

    Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.

Secondary Outcomes (6)

  • Change in PaCO2

    Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.

  • Change in peripheral oxygen saturation (SpO2)

    Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.

  • Change in respiratory frequency

    Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.

  • Change in mean arterial pressure (MAP)

    Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.

  • Change in heart rate

    Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.

  • +1 more secondary outcomes

Study Arms (1)

Positive expiratory pressure (PEP)

OTHER

PEP 10 cmH2O 15 min

Procedure: PEP

Interventions

PEPPROCEDURE

Positive expiratory pressure 10 cmH2O 15 min

Positive expiratory pressure (PEP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tracheostomized participants
  • ≥18 years old
  • Moderate or severe ARDS during the ICU period, according to the Berlin definition.
  • Ability to maintain PaO2 ≥ 67.5mmHg, with supplementary oxygen if needed, during spontaneous breathing for at least three consecutive hours.
  • Normal curvature of the spine.

You may not qualify if:

  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 17, 2020

Study Start

February 1, 2012

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

June 17, 2020

Record last verified: 2020-06