Weaning From Mechanical Ventilation Using Permissive Hypercarbia
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|ClinicalTrials.gov Identifier: NCT00357929|
Recruitment Status : Terminated (insufficient recruitment)
First Posted : July 28, 2006
Last Update Posted : October 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Respiration, Artificial Respiratory Distress Syndrome, Adult||Procedure: Permissive hypercarbia||Not Applicable|
The primary objective of this research is to assess the utility of permissive hypercarbia (PH) in the weaning of patients with risk factors for difficult weaning from mechanical ventilation. This pilot study seeks to validate the concept that PH will significantly improve the ability of patients to be weaned from mechanical ventilation and change the approach that physicians take to ventilator weaning for many patients.
Null Hypothesis: Patients with PH will not be weaned from mechanical ventilation more rapidly than those not receiving PH.
Patients with significant lung disease fail weaning from mechanical ventilation either as a result of an inability to oxygenate the blood or to adequately remove carbon dioxide. This results in longer Intensive Care Unit stays and increased morbidity and mortality as these patients have prolonged periods of mechanical ventilation. This study will focus on patients who have failure to adequately remove carbon dioxide (ventilatory failure) and endeavors to evaluate a method for enhanced carbon dioxide elimination by altering the acid-base status of the patients utilizing permissive hypercarbia (PH). PH will be used specifically during weaning from mechanical ventilation to enhance carbon dioxide elimination during this period. PH has used by some intensivists for this purpose but has not been critically evaluated in a clinical study.
Mechanical ventilation using PH maintains an increased CO2 with either partial or complete metabolic compensation. Therefore, the blood pH is either normal or slightly reduced. In patients who are adequately sedated, the reduced pH is well tolerated without respiratory distress or air hunger. However, if PH is to be used in awake patients as proposed here, full metabolic compensation would be required to avoid air hunger while being weaned from ventilator support. The metabolic compensation is produced either as a result of a renal compensation or, more typically in the ICU setting, iatrogenically. Metabolic alkalosis can be produced through the administration of alkalinizing agents or as a result of gastric suctioning or from contraction alkalosis resulting from the use of diuretics.
PH enhances CO2 elimination by increasing the concentration of CO2 in the exhaled gas. The pulmonary capillary pCO2 is elevated and therefore so is the alveolar CO2 and the exhaled or end-tidal CO2. Thus more CO2 is exhaled in an equal volume of exhaled gas. This increased CO2 concentration reduces the minute ventilation required to exhale the CO2 produced by the patient. PH will decrease the minute ventilation requirement even in patients with an increased dead space and will facilitate weaning these patients from mechanical ventilation by the same mechanism as just described.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weaning From Mechanical Ventilation Using Permissive Hypercarbia|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||June 14, 2007|
|Actual Study Completion Date :||June 14, 2007|
- Time for weaning from positive pressure support mechanical ventilation
- Percentage of subjects/group successfully weaned within seven days of trial participation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357929
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Kane M High, MD||Penn State University, College of Medicine, Penn State Milton S. Hershey Medical Center|