Respiratory FailureNCT01705119
The Effects of Vertical Position on Gas Exchange in Patients With Respiratory Failure
A study testing Standing in people with Respiratory Failure, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Standing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2012to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged ≥18 years who are mechanically ventilated
- An oxygen saturation of 88-94% or an arterial line
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
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?
Read the 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
- 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.
- Conditions
- Respiratory Failure
- Being tested
- Standing
- Keywords
- Mechanically Ventilated, Critical Care
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandingOther
| Study group | Role | What they receive |
|---|---|---|
| Mechanically Ventilated | Experimental | Not described Receives: Other: Standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2 to FiO2 ratio
Measured: change from baseline to 1 hr
Secondary outcomes (3)
Oxygen Saturation
Measured: change from baseline to 1 hr
change in blood PCO2
Measured: change from baseline to 1 hr
Change in blood pH
Measured: change from baseline to 1hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study start1 Oct 2012
- Primary completion10 Jun 2021
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Kress, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705119
- Sponsor's protocol ID
- 12-1773
- Status last verified
- Jan 2026
- First submitted
- 8 Oct 2012
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vertical Position on Gas Exchange in Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT01705119
- Acronym / sponsor ID
- 12-1773
- Conditions
- Respiratory Failure
- Keywords
- Mechanically Ventilated, Critical Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Oct 2012 (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.
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
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically Ventilated | Experimental | Other: Standing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥18 years who are mechanically ventilated
- An oxygen saturation of 88-94% or an arterial line
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Standing | Other | Mechanically Ventilated |
Primary outcome
PaO2 to FiO2 ratio
Time frame: change from baseline to 1 hr
3 secondary outcomes
Oxygen Saturation
Time frame: change from baseline to 1 hr
change in blood PCO2
Time frame: change from baseline to 1 hr
Change in blood pH
Time frame: change from baseline to 1hr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
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Mechanical Ventilator Adjustments and Patient Dyspnea
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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.
John P Kress, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standing in people with Respiratory Failure, run by University of Chicago 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 2 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
PaO2 to FiO2 ratio (time frame: change from baseline to 1 hr). 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 13 Jan 2026.