An interventional study of PEEP guided by Esophageal pressure + Recruitment maneuver in ARDS, sponsored by Wolfson Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-29.
Sponsored by Wolfson Medical Center · Not applicable, Interventional, and Treatment
The aim of the study is to examine the effects of two different levels of PEEP on subsequent standard recruitment maneuver.
In this study we will examine the effects of two levels of PEEP on subsequent recruitment maneuver. In the first group a recruitment maneuver will be performed in patients who are ventilated with PEEP level set according to the ARDS network algorithm.
Patients will then be crossed over to a study arm where another recruitment maneuver will be performed while PEEP is adjusted according to esophageal pressure measurements.
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.
20 Man and women older than 18 years will be recruited.
Patients with acute respiratory failure of any cause who are mechanically ventilated according to the ARDS network recommendations will be considered for inclusion to the study.
To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of 25 to 30 cmH2O) has to be present, and at least one of the following four severity inclusion criteria has to be met.
1 - 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.
Exclusion Criteria:
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.
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
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.
oxygenation
the primary end point in both groups will be oxygenation improvement after each intervention in each arm.
Time frame: 4 hours
lung compliance
after each intervention lung compliance will be assessed.
Time frame: 4 hours
This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wolfson Medical Center