Respiration, ArtificialNCT00357929
Weaning From Mechanical Ventilation Using Permissive Hypercarbia
A study testing Permissive hypercarbia in people with Respiration, Artificial and Respiratory Distress Syndrome, Adult, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial, Respiratory Distress Syndrome, Adult
- What is being tested?
- Permissive hypercarbia
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to 14 Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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.
- Being tested
- Permissive hypercarbia
- Keywords
- permissive hypercarbia, weaning from mechanical ventilation
- Medical subject headings
- Respiratory Aspiration, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permissive hypercarbiaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for weaning from positive pressure support mechanical ventilation
Secondary outcomes (1)
Percentage of subjects/group successfully weaned within seven days of trial participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startAug 2006
- Primary completion14 Jun 2007
- Study completion14 Jun 2007
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kane High, Milton S. Hershey Medical Center
- Investigators
- Kane M High, MD, Principal investigator, Penn State University, College of Medicine, Penn State Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357929
- Sponsor's protocol ID
- 23214
- Status last verified
- Oct 2017
- First submitted
- 27 Jul 2006
- Last updated
- 20 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Mechanical Ventilation Using Permissive Hypercarbia
- ClinicalTrials.gov ID
- NCT00357929
- Acronym / sponsor ID
- 23214
- Keywords
- permissive hypercarbia, weaning from mechanical ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- 14 Jun 2007 (actual)
- Study completion
- 14 Jun 2007 (actual)
- First posted
- 28 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permissive hypercarbia | Procedure or surgery | – |
Primary outcome
Time for weaning from positive pressure support mechanical ventilation
1 secondary outcome
Percentage of subjects/group successfully weaned within seven days of trial participation
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kane M High, MD principal investigator
Penn State University, College of Medicine, Penn State Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permissive hypercarbia in people with Respiration, Artificial and Respiratory Distress Syndrome, Adult, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for weaning from positive pressure support mechanical ventilation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.