NCT02945917

Brief Summary

The use of esophageal balloon catheter to estimate pleural pressure has gained renewed popularity in recent years. Indeed, measurement of transpulmonary pressure may allow a more pathophysiological-based approach to ventilator strategy in acute respiratory distress syndrome (ARDS) patients. Nevertheless, it is well known that esophageal balloon catheter derived parameters can be influenced by several patient-related or technical-related factors. During a PEEP trial, the investigators will observe in-vivo the esophageal pressure and derived measurements obtained using different esophageal balloon calibration volumes.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

October 20, 2016

Last Update Submit

October 25, 2016

Conditions

ARDS

Outcome Measures

Primary Outcomes (1)

  • transpulmonary pressure measured estimating pleural pressure through the esophageal balloon

    within 10 minutes after esophageal balloon volume changing

Secondary Outcomes (1)

  • End-expiratory lung volume

    within 60 minutes after PEEP changing

Eligibility Criteria

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

ARDS patients undergoing volume control mechanical ventilation

You may qualify if:

  • Diagnosis of ARDS with a PEEP of at least 8 cmH2O
  • Fraction of inspired oxygen not higher than 80%
  • Intubated and ventilated in Volume Control Ventilation mode set by the attending physician according to clinical criteria
  • Need of continuous sedation through intravenous anesthetics and full neuromuscular blockade

You may not qualify if:

  • Been pregnant or breastfeeding
  • Hemodynamic instability
  • Presence of tracheobronchial fistula
  • Known pneumothorax
  • Leak in airway circuitry
  • Presence of any kind of inhalator therapy (e.g. Heliox, nitric oxide, anesthetic conserving device)
  • Recent history of nasal trauma or lesion of nasal cavity
  • Recent history of esophageal, gastrointestinal, ENT, thoracic or cardiac surgery (less than 2 months)
  • Known or suspected esophageal varices
  • Congenital, acquired or drug-induced hemostatic disorder
  • Thrombocytopenia (less than 50000/mm3)
  • Recent history of Traumatic Brain Injury or thoraco-abdominal trauma (less than 1 months)
  • Rib or sternal fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOC Anestesia e Rianimazione

Monza, Monza E Brianza, 20900, Italy

RECRUITING

Central Study Contacts

Federico Magni

CONTACT

+390392332127magnifederico@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
UOC Anestesia e Rianimazione ASST Monza

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 26, 2016

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

IT(1)