PEEP Guided by Esophageal Balloon Measurement and Its Effect on Recruitment Maneuver

NCT01737190 | Unknown

• 1 other identifier: 0161-12-WOMC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to examine the effects of two different levels of PEEP on subsequent standard recruitment maneuver.

Conditions

ARDS

Keywords

esophageal pressure; ARDSnet protocol

Outcome Measures

Primary Outcomes (1)

• oxygenation

  the primary end point in both groups will be oxygenation improvement after each intervention in each arm.

  4 hours

Secondary Outcomes (1)

• lung compliance

  4 hours

Study Arms (1)

PEEP guided by Esophageal pressure + Recruitment maneuver.

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 expiarory pressure of not more than 5 cm H2O. A recruitment maneuver with application of 40 cm H2O for up to 40 seconds will be performed.

Other: PEEP guided by Esophageal pressure + Recruitment maneuver

Interventions

PEEP guided by Esophageal pressure + Recruitment maneuver 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 expiarory pressure of not more than 5 cm H2O. A recruitment maneuver with application of 40 cm H2O for up to 40 seconds will be performed.

PEEP guided by Esophageal pressure + Recruitment maneuver.

Eligibility Criteria

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

You may qualify if:

• Man and women older than 18 years will be recruited.
• 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 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 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 kyphoskoliosis.

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

IL (1)