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Three Methods for Best PEEP Determination Compared With PEEP Determination Guided by Adult Respiratory Distress Syndrome (ARDS) Network

NCT01742715 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-12-05

No results posted yet for this study

Summary

To compare the best Positive End Expiratory Pressure (PEEP) as determined by one of three commonly used clinical approaches for best PEEP determination, with PEEP guided by the ARDS network algorithm.

Conditions

  • ARDS

Interventions

OTHER

PEEP by Best oxygenation

Set PEEP at 25 cmH2O with fixed driving pressure that will result in delivery of a fixed Tidal Volume (TV) of 6ml/kg (IBW). FiO2 is set to 60%. Then decrease PEEP in steps of 4 cmH2O every 10 min until PEEP of 5 cm H2O is reached. In each step static compliance of respiratory system and lung compliance will be measured along with ABGs, and hemodynamic parameters such as cardiac output and mixed venous O2 saturation. Best or optimal PEEP will be defined as the PEEP below which PaO2 /FIO2 falls by at least 20%. If at least 20% PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected.

OTHER

PEEP by Best Compliance

In this group assessment begins with measuring intrinsic PEEP by an expiratory hold. Thereafter, plateau pressures will be recorded after a 0.5-sec inspiratory pause. Applied PEEP will be increased by steps of 4 cm H2O, after each incremental step the patient will be observed for 10 minutes to allow for lung unit recruitment and equilibration. Plateau pressure will be measured after each incremental step of PEEP. Applied PEEP will be increased sequentially by 4 cm H2O increments until peak inspiratory pressure of 50 cm H2O, or plateau pressure of 40 cm H2O reached, or hypotension or decrease of 20% in cardiac output is observed.

OTHER

PEEP by Esophageal pressure

Upon patient recruitment Esophageal balloon will be inserted and esophageal / pleural pressure will be measured. Thereafter, Inspiratory pressures and PEEP will be adjusted according to well established criteria. Inspiratory pressure and PEEP will be adjusted to achieve the best lung compliance possible while not exceeding transpulmonary end Inspiratory pressure of 25 to 30 cm H2O, and at the same time maintaining a positive transpulmonary end expiratory pressure of not more than 5 cm H2O.

Sponsors & Collaborators

  • Wolfson Medical Center

    lead OTHER_GOV

Principal Investigators

  • Arie Soroksky, M.D. · Wolfson MC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01742715 on ClinicalTrials.gov