NCT02889770

Brief Summary

This studies´ objective is to describe how different PEEP levels affect dead space measured by Bohr´s formula.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

August 31, 2016

Last Update Submit

September 6, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dead space variation

    How dead space, measured by Bohr´s formula, varies with different PEEP levels during a recruitment manouver

    60 min

Interventions

Exposure to different PEEP levels

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ARDS patients

You may qualify if:

  • age older than 18 years
  • requirement of invasive mechanical ventilation for more than 4 hours and less than 12 hours
  • severe hypoxemia (PAFI \< 200) secondary to ARDS or post-operatory atelectasis

You may not qualify if:

  • requirement of invasive mechanical ventilation prior to enrollment in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Emiliano Gogniat, PT

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 7, 2016

Study Start

September 1, 2013

Primary Completion

October 1, 2015

Study Completion

June 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09