Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Patients with acute respiratory failure exhibiting decreased respiratory system compliance with hypoxemia or carbon dioxide retention are often difficult to ventilate with current guidelines that limit applied plateau pressure Yet, these guidelines do not take into consideration chest wall mechanics. The investigators sought to determine whether partition of the respiratory system into its components by measuring esophageal pressure and thus assessment of pleural pressure, would help in patients with acute respiratory failure to identify the factors contributing to low respiratory system compliance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
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
First Submitted
Initial submission to the registry
July 23, 2012
CompletedFirst Posted
Study publicly available on registry
August 20, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedAugust 20, 2012
August 1, 2012
1 year
July 23, 2012
August 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxygenation
1 year
Secondary Outcomes (1)
lung compliance, expressed as ml/cmH2O.
1 year
Study Arms (1)
Esophageal balloon group
OTHEREsophageal balloon will be inserted, and esophageal pressure will be measured in patients with acute respiratory failure. Intervention - PEEP and Inspiratory pressure will be adjusted according to the measured esophageal pressure.
Interventions
esophageal pressure as a surrogate for pleural pressure
Eligibility Criteria
You may qualify if:
- Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - P/F ratio of less than 300. 3 - Need for a PEEP greater than 10 cmH2O to maintain SaO2 of \> 90%. 4 - PCO2 over 60 mmHg, or PH less than 7.2 that is attributed to respiratory acidosis.
You may not qualify if:
- Patients with any of the following were excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PMID: 19001507RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arie Soroksky, MD
Wolfson MC
Central Study Contacts
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
- M.D.
Study Record Dates
First Submitted
July 23, 2012
First Posted
August 20, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
August 20, 2012
Record last verified: 2012-08