NCT04067154

Brief Summary

The study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

August 21, 2019

Last Update Submit

August 22, 2019

Conditions

ARDS

Outcome Measures

Primary Outcomes (1)

  • Gas Exchange and lung recruitability at diferent PEEP levels

    Gas exchange (At PEEP 5 and 20 cm H2O), CT scan (At PEEP 5, 20 and 45 cm H2O)

    Approximately two hours

Secondary Outcomes (2)

  • Physiologic Parameter 1

    Approximately two hours

  • Physiologic Parameter 2

    Approximately two hours

Study Arms (1)

ALPE-TAC

EXPERIMENTAL

ARDS patients on mechanical ventilation. Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O to evaluate potential for recruitment and measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O

Diagnostic Test: ALPE

Interventions

ALPEDIAGNOSTIC_TEST

Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O Measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O

ALPE-TAC

Eligibility Criteria

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

You may qualify if:

  • \- ARDS patients requiring mechanical ventilation

You may not qualify if:

  • \<18 years old
  • Requirement of extracorporal life support
  • Hemodynamic instability
  • Barotrauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

Related Publications (1)

  • Karbing DS, Panigada M, Bottino N, Spinelli E, Protti A, Rees SE, Gattinoni L. Changes in shunt, ventilation/perfusion mismatch, and lung aeration with PEEP in patients with ARDS: a prospective single-arm interventional study. Crit Care. 2020 Mar 23;24(1):111. doi: 10.1186/s13054-020-2834-6.

    PMID: 32293506DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Does a bedside method for describing functional gas exchange compare well with anatomical description via CT scans, and could it predict the effects of recruitment and ventilation/perfusion mismatch improvement.

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 26, 2019

Record last verified: 2019-08

Locations

IT(1)