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

Primary Purpose

Respiratory Failure

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standing
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Mechanically Ventilated, Critical Care

Eligibility Criteria

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

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

Sites / Locations

  • University of Chicago Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mechanically Ventilated

Arm Description

Outcomes

Primary Outcome Measures

PaO2 to FiO2 ratio

Secondary Outcome Measures

Oxygen Saturation
change in blood PCO2
Change in blood pH

Full Information

First Posted
October 8, 2012
Last Updated
May 11, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01705119
Brief Title
The Effects of Vertical Position on Gas Exchange in Patients With Respiratory Failure
Official Title
The Effects of Vertical Position on Gas Exchange in Patients With Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Mechanically Ventilated, Critical Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mechanically Ventilated
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Standing
Primary Outcome Measure Information:
Title
PaO2 to FiO2 ratio
Time Frame
change from baseline to 1 hr
Secondary Outcome Measure Information:
Title
Oxygen Saturation
Time Frame
change from baseline to 1 hr
Title
change in blood PCO2
Time Frame
change from baseline to 1 hr
Title
Change in blood pH
Time Frame
change from baseline to 1hr
Other Pre-specified Outcome Measures:
Title
Tidal Volume
Time Frame
change from baseline to 1 hr
Title
Vital Signs
Time Frame
change from baseline to 1hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Kress, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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

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