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Weaning From Mechanical Ventilation Using Permissive Hypercarbia

Primary Purpose

Respiration, Artificial, Respiratory Distress Syndrome, Adult

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Permissive hypercarbia
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiration, Artificial focused on measuring permissive hypercarbia, weaning from mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult (> 18 yo) patients in the intensive care units at the Hershey Medical Center who are on mechanical ventilation and whose clinical course permits weaning from mechanical ventilation and are felt to have risk factors for difficult weaning. (Risk factors will include patients with rib fractures, pulmonary contusions, obesity (BMI >30), or history of COPD or other significant lung disease.) all patients will have failed (rapid shallow breathing index >105) a 30 minute spontaneous breathing test. Exclusion Criteria: Overt signs of sepsis including: a temperature > 38.5F, white blood cell count > 14000, systolic blood pressure < 100 mmHg, intracranial hypertension (ICP > 18 or based upon clinical exam and/or history), or pulmonary hypertension (by history or PAsys > 40 mmHg). or history of recent(past 6 mos)MI

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Outcomes

Primary Outcome Measures

Time for weaning from positive pressure support mechanical ventilation

Secondary Outcome Measures

Percentage of subjects/group successfully weaned within seven days of trial participation

Full Information

First Posted
July 27, 2006
Last Updated
October 18, 2017
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00357929
Brief Title
Weaning From Mechanical Ventilation Using Permissive Hypercarbia
Official Title
Weaning From Mechanical Ventilation Using Permissive Hypercarbia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 14, 2007 (Actual)
Study Completion Date
June 14, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration, Artificial, Respiratory Distress Syndrome, Adult
Keywords
permissive hypercarbia, weaning from mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Permissive hypercarbia
Primary Outcome Measure Information:
Title
Time for weaning from positive pressure support mechanical ventilation
Secondary Outcome Measure Information:
Title
Percentage of subjects/group successfully weaned within seven days of trial participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (> 18 yo) patients in the intensive care units at the Hershey Medical Center who are on mechanical ventilation and whose clinical course permits weaning from mechanical ventilation and are felt to have risk factors for difficult weaning. (Risk factors will include patients with rib fractures, pulmonary contusions, obesity (BMI >30), or history of COPD or other significant lung disease.) all patients will have failed (rapid shallow breathing index >105) a 30 minute spontaneous breathing test. Exclusion Criteria: Overt signs of sepsis including: a temperature > 38.5F, white blood cell count > 14000, systolic blood pressure < 100 mmHg, intracranial hypertension (ICP > 18 or based upon clinical exam and/or history), or pulmonary hypertension (by history or PAsys > 40 mmHg). or history of recent(past 6 mos)MI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kane M High, MD
Organizational Affiliation
Penn State University, College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Weaning From Mechanical Ventilation Using Permissive Hypercarbia

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