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The Effects of Vertical Position on Gas Exchange in Patients With Respiratory Failure

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ClinicalTrials.gov Identifier: NCT01705119
Recruitment Status : Recruiting
First Posted : October 12, 2012
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to investigate how changing from a supine to upright position affects gas exchange for patients with hypoxemic respiratory failure.

The research question is: will oxygen saturation and/or partial pressure of oxygen in the blood change when a patient with hypoxemic respiratory failure moves from a supine to upright position?


Condition or disease Intervention/treatment
Respiratory Failure Other: Standing

Detailed Description:

Our hypothesis is that blood oxygen tension will not decrease and may even increase when a patient with respiratory failure stands up. Supine positioning often causes partial lung collapse, which results in a decreased amount of lung being available for gas exchange. In patients with Acute Respiratory Distress Syndrome (ARDS), tilting the patient up in bed has been shown to increase oxygen tension and improve lung compliance. Positional changes are sometimes used as a "rescue" intervention in patients with severe hypoxemia from ARDS. The investigators hope to conclude that severe hypoxemia should not be viewed as a contraindication to physical therapy, but rather physical therapy may be a potential intervention for patients with marginal gas exchange.

After sedative interruption, physical therapists and nursing staff will assist mechanically ventilated patients in moving to the side of the bed. They will assess the extremity strength using the MRC scale. If lower extremity strength is at least 4/5, the patient will be assisted to assume the upright position. The investigators will monitor the patient continuously and the session will be stopped at any point for

A. Mean arterial pressure <65 B. Heart rate <40, >130 beats/min C. Respiratory rate <5, >40 breaths/ min D. Pulse oximetry <88% E. Marked ventilator dyssynchrony F. Patient distress G. New arrhythmia H. Concern for myocardial ischemia I. Concern for airway device integrity J. Endotracheal tube removal

At this point, the patient's vital signs, pulse oximetry, and measures of lung compliance will be obtained. If an arterial line is in place and there have been ventilator adjustments since the morning arterial blood gas, the investigators will draw an arterial blood gas.

The physical therapists and nursing staff will then help the patient stand up. After one minute, the investigators will record another set of vital signs, pulse oximetry, and measures of lung compliance from the mechanical ventilator. If an arterial line is in place, the investigators will draw another arterial blood gas.

The patient will then be assisted back into bed. One hour later, the investigators will record the patient's vital signs, pulse oximetry, and measures of lung compliance from the mechanical ventilator.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Vertical Position on Gas Exchange in Patients With Respiratory Failure
Study Start Date : October 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mechanically Ventilated Other: Standing


Outcome Measures

Primary Outcome Measures :
  1. PaO2 to FiO2 ratio [ Time Frame: change from baseline to 1 hr ]

Secondary Outcome Measures :
  1. Oxygen Saturation [ Time Frame: change from baseline to 1 hr ]
  2. change in blood PCO2 [ Time Frame: change from baseline to 1 hr ]
  3. Change in blood pH [ Time Frame: change from baseline to 1hr ]

Other Outcome Measures:
  1. Tidal Volume [ Time Frame: change from baseline to 1 hr ]
  2. Vital Signs [ Time Frame: change from baseline to 1hr ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged ≥18 years who are mechanically ventilated
  • An oxygen saturation of 88-94% or an arterial line

Exclusion Criteria:

  • Mean arterial pressure <65
  • Heart rate < 40 or > 130 beats/min
  • Respiratory rate < 5 or > 40 breaths/min
  • Pulse oximetry < 88%
  • Evidence of elevated intracranial pressure
  • Active gastrointestinal blood loss
  • Active myocardial ischemia
  • Pregnancy
  • Actively undergoing a procedure
  • Patient agitation requiring increased sedative administration in the last 30 mins
  • Insecure airway (device)
  • The patient was not ambulatory prior to hospitalization
  • The patient's body habitus and/or mental status make it unsafe to stand up
  • The patient has been placed on strict bed rest by the treating physicians
Contacts and Locations

Information from the National Library of Medicine

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): NCT01705119


Contacts
Contact: Anne Pohlman, RN 773-702-3804 apohlman@medicine.bsd.uchicago.edu
Contact: John P Kress, MD 773-702-6404 jkress@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Anne Pohlman, RN    773-702-3804    apohlman@medicine.bsd.uchicago.edu   
Principal Investigator: John P Kress, MD         
Sub-Investigator: Jared A Greenberg, MD         
Sub-Investigator: Bhakti Patel, MD         
Sub-Investigator: Maggie Davis-Hovda, MD         
Sub-Investigator: Anne Pohlman         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: John P Kress, MD University of Chicago
More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01705119     History of Changes
Other Study ID Numbers: 12-1773
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by University of Chicago:
Mechanically Ventilated
Critical Care

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases