Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357929
Status:
TERMINATED
Last Update Posted:
2017-10-20
First Post:
2006-07-27
Brief Title:
Weaning From Mechanical Ventilation Using Permissive Hypercarbia
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Weaning From Mechanical Ventilation Using Permissive Hypercarbia
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some patients receiving mechanical ventilation have difficulty weaning off the ventilator because of physiological factors such as pre-existing lung disease respiratory distress syndrome and trauma among others Allowing patients to become hypercarbic increased blood bicarbonate level may make it easier for these patients to be taken off the ventilator and resume breathing on their own
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None