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

NCT01742715 | Unknown

• 1 other identifier: 0156-12-WOMC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ARDS; Lung compliance

Outcome Measures

Primary Outcomes (1)

• Oxygenation (defined by partial O2 pressure divided by Fractional inspired Oxygen tension or P/F ratio)

  oxygenation (defined by partial O2 pressure divided by Fractional inspired Oxygen tension or P/F ratio)

  2 hours

Secondary Outcomes (1)

• Lung compliance (defined by Tidal Volume divided by Inspiratory transpulmonary pressure)

  2 hours

Study Arms (3)

PEEP by Best oxygenation

EXPERIMENTAL

Set Positive End Expiratory Pressure (PEEP) at 25 cmH2O with fixed driving pressure that will result in delivery of a fixed Tidal Volume (TV) of 6ml/kg Ideal Body Weight (IBW). fraction of inspired oxygen (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 arterial blood gas (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% Partial Oxygen tension (PaO2) PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected.

Other: PEEP by Best oxygenation; Other: PEEP by Best Compliance; Other: PEEP by Esophageal pressure

PEEP by Best Compliance

EXPERIMENTAL

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 Best oxygenation; Other: PEEP by Best Compliance; Other: PEEP by Esophageal pressure

PEEP by Esophageal pressure

EXPERIMENTAL

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.

Other: PEEP by Best oxygenation; Other: PEEP by Best Compliance; Other: PEEP by Esophageal pressure

Interventions

PEEP by Best oxygenation OTHER

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.

Also known as: PEEP determined by Best oxygenation approach.

PEEP by Best Compliance; PEEP by Best oxygenation; PEEP by Esophageal pressure

PEEP by Best Compliance OTHER

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.

PEEP by Best Compliance; PEEP by Best oxygenation; PEEP by Esophageal pressure

PEEP by Esophageal pressure OTHER

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.

PEEP by Best Compliance; PEEP by Best oxygenation; PEEP by Esophageal pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - PaO2 /FIO2 ratio of less than 300. 3 - Need for a PEEP greater than 10 cmH2O to maintain arterial oxygen saturation (SaO2) of \> 90%.
• carbon dioxide partial pressure (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 will be 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 kyphoscoliosis.

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

E. Wolfson MC

Holon, 58100, Israel

Location

Study Officials

• Arie Soroksky, M.D.

  Wolfson MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 5, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 5, 2012

Record last verified: 2012-10

Locations

IL (1)