CClinicalTrials.gg
Status unknownNCT01668368Updated Aug 20, 2012

Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance

An interventional study of esophageal balloon in Acute Respiratory Failure and ARDS, sponsored by Wolfson Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-20.

Sponsored by Wolfson Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Identifying the dominant factor affecting respiratory system compliance by measuring transpulmonary pressure may better direct and optimize mechanical ventilation. Thus, instead of limiting mechanical ventilation by plateau pressure, PEEP and Inspiratory pressure adjustment would be individualized specifically for each patient's lung compliance as indicated by transpulmonary pressure.

The main goal of this approach is to specifically target transpulmonary pressure instead of plateau pressure, and therefore achieve the best Lung compliance with the least transpulmonary pressure possible.

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Conditions studied

  • Acute Respiratory Failure
  • ARDS

Keywords

  • ARDS
  • Esophageal pressure
  • pleural pressure
  • pulmonary compliance
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 50 is close to the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Wolfson Medical Center is the lead sponsor of 113 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of up to 30 cmH2O) had to be present, and at least one of the following four inclusion criteria had to be met.

    1 - 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Esophageal balloon group

    Esophageal 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.

    Other: esophageal balloon

Interventions

  • Otheresophageal balloon

    esophageal pressure as a surrogate for pleural pressure

    Also known as: pleural pressure

06

What researchers measure

Primary outcomes

  1. Oxygenation

    Time frame: 1 year

Secondary outcomes

  1. lung compliance, expressed as ml/cmH2O.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 19001507 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01668368
Lead sponsor
Wolfson Medical Center
Responsible party
Soroksky Arie (M.D., Wolfson Medical Center) — Principal investigator
First posted
Aug 20, 2012
Start date
Sep 2012
Primary completion
Sep 2013 (estimated)
Completion
Sep 2013 (estimated)
Last update
Aug 20, 2012

Study contacts

Arie Soroksky, M.D.
Contact
soroksky@gmail.com
972-50-4056787
Arie Soroksky, MD
principal investigator · Wolfson MC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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