NCT02388282

Brief Summary

Dinamic intrinsic PEEP is

Trial Health

87
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 Apr 2015

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

March 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 29, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

March 9, 2015

Last Update Submit

December 28, 2015

Conditions

PEEP, IntrinsicPEEP, OccultRespiratory Insufficiency

Keywords

dynamic intrinsic PEEPdiaphragm echographyrespiratory mechanics

Outcome Measures

Primary Outcomes (1)

  • Correlation and agreement between AutoPEEP recorded with the transdiaphragmatic pressure (Pdi) vs ecography measurements.

    20 minutes

Secondary Outcomes (2)

  • Correlation and agreement between neural inspiratory time and ecographic inspiratory time

    10 minutes

  • Inter-rater agreement to assest method reliability

    10 minutes

Interventions

diaphragm ecographyDEVICE

recording of diaphragm ecography

Eligibility Criteria

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

Patients with both acute or chronic respiratory insufficiency, who required respiratory mechanics measurements for clinical purpose.

You may qualify if:

  • Acute or chronic respiratory failure
  • Age \>=18 y

You may not qualify if:

  • Lack of informed consent
  • Controindication to the placement of oesophageal and gastric catheter:
  • esophageal varices, gastric or oesophageal bleeding in the previous 30 days, gastric or oesophageal surgery in the preceding year.
  • Cardiac arrest
  • Severe emodinamic instability (\> 1 vasoacttive drug)
  • Acute coronary syndrome (AMI/UA)
  • Inability to protect airway
  • Respiratory arrest
  • Pregnancy suspected or confirmed
  • Diaphragm palsy
  • Curarization in the preceding five hours
  • Mechanical ventilation in controlled mode.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sant'Orsola Malpighi

Bologna, 40185, Italy

Location

Related Publications (1)

  • Bernardi E, Pisani L, Fasano L, Lauria G, Comellini V, Appendini L, Conti G, Tosello F, Pizzolato E, Nava S. A New Ultrasound Method for Estimating Dynamic Intrinsic Positive Airway Pressure: A Prospective Clinical Trial. Am J Respir Crit Care Med. 2018 Aug 1;198(3):392-396. doi: 10.1164/rccm.201706-1292LE. No abstract available.

    PMID: 29558160DERIVED

MeSH Terms

Conditions

Positive-Pressure Respiration, IntrinsicRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 17, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 29, 2015

Record last verified: 2015-08

Locations

IT(1)