Critical IllnessNCT02160561
Feasibility of Upright Bed Position in ARDS Patients
A study testing Intervention Arm in people with Critical Illness and Acute Respiratory Failure, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Lower lobe atelectasis of the lung is common in Acute Respiratory Distress Syndrome (ARDS) and has the potential to adversely impact lung compliance and intra-pulmonary shunt. The cephalic shift of the diaphragm and dorsal atelectasis associated with the commonly used supine position might also contribute to this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Respiratory Failure, Adult Syndrome
- What is being tested?
- Intervention Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2015
- 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
- Mechanically ventilated
- Chest radiograph must show parenchymal lung infiltrates.
- Acute Lung Injury
- Study shall occur 96 hours after consent has been obtained
Who cannot join
- Hemodynamic instability and/or use of a vasopressor within the last 6 hours prior to enrollment.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health, Medical Intensive Care Unit
Winston-Salem, North Carolina, 27157
About this study
Lower lobe atelectasis of the lung is common in Acute Respiratory Distress Syndrome (ARDS) and has the potential to adversely impact lung compliance and intra-pulmonary shunt. The cephalic shift of the diaphragm and dorsal atelectasis associated with the commonly used supine position might also contribute to this shunt. Reports indicate that obese patients may be more likely to develop dorsal atelectasis than non-obese patients.
The investigators hypothesized that opening the body position angle at the waist from a typical head of bed at 30 degrees to one similar to a more upright reverse trendelenburg position, would alter the position of the diaphragm downward, allowing for improved aeration of lung bases. Thus, the investigators examined the upright body positioning in mechanically ventilated patients with ARDS primarily by evaluating for effects on oxyhemoglobin saturation (O2sat), Tidal Volume (TV) and Respiratory Rate (RR).
Read the detailed description
Acute respiratory failure and acute respiratory distress syndrome is a life-threatening occurrence. The annual incidence of ARDS is 141,500 patients, with 59,000 deaths, and a cost of 1,642,000 hospital days/year. Within this population, special care needs of obese patients are becoming a clinically important entity within the Intensive Care Unit (ICU). ICU literature on body positioning for obese mechanically ventilated patients is limited. Currently, intubated obese patients are placed in the supine position with the head of bed elevated at 30 degrees. The 30 degree head up position has been adopted for all patients as a reflection of the Ventilator Associated Pneumonia prevention literature. In all critically ill patients on mechanical ventilation, a cephalic shift of the diaphragm along with dorsal atelectasis of the lung occurs. In obese patients this alteration may be associated with greater degree of impairment in lung compliance and gas exchange as compared to non-obese ventilated patients. It is possible that current ICU body positioning recommendations for obese mechanically ventilated patients may be detrimental due to the obese abdominal compartment hampering normal diaphragm function and position.
In supine, intubated, mechanically ventilated patients it has long been noted that lower lung lobes become atelectatic soon after intubation due to several factors such as accumulation of fluids, air closure, and a cephalic shift of the diaphragm. Obese patients develop more atelectasis during anesthesia than non-obese patients. There have been attempts to correct this iatrogenic complication in critically ill patients such as placement of patients in the prone position. Prone positioning does resolve the dorsal atelectasis and shows improvement in hypoxia. However there is no mortality benefit with prone positioning. Also, continuous lateral rotational patient positioning on mechanical ventilation has shown similar effects7. Specific literature with regards to obese patients and their unique susceptibility towards this phenomenon is limited.
As BMI increases there is an associated reduction of lung volumes, expiatory reserve volume, and functional reserve capacity. It is also known that in the reverse trendelenburg position, there is a gravitational pull allowing abdominal contents to descent toward the pelvis. This position of the abdominal contents allows for a more functional diaphragm position. One observational study 10 conducted a 12 hour intervention which examined upright position with patients' body in a straight line at 40-45 degrees (i.e., reverse trendelenburg-no bend at the waist). This study demonstrated a significant increase in the PaO2/FiO2 ratio (ie, oxygenation) during upright position.
- Conditions
- Critical Illness, Acute Respiratory Failure, Adult Syndrome
- Being tested
- Intervention Arm
- Keywords
- mechanical, ventilation, acute, respiratory, failure
- Medical subject headings
- Critical Illness, Propping Zerres syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ArmOther
Placing patients who are in critical illness with acute respiratory failure and are mechanically ventilated in an upright reverse trendelenburg position
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Experimental - Intervention Arm patients who are in critical illness with acute respiratory failure and are mechanically ventilated will be placed in an upright reverse trendelenburg position Receives: Other: Intervention Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with change in hemodynamic stability from baseline when placed in upright position
Hemodynamic stability will be determined by changes from baseline in blood pressure or heart rate when participants are placed in an upright position.
Measured: Three hours
Secondary outcomes (3)
Number of participants with change in Oxyhemoglobin Saturation from baseline when placed in upright position
Oxyhemoglobin saturation levels will be monitored when participant is placed in upright position. Change from baseline level will be recorded.
Measured: Three hours
Number of participants with Change in Tidal Volume from baseline when placed in upright position
Tidal volume will be monitored when participant is placed in upright position. Change from baseline level will be recorded.
Measured: Three hours
Number of participants with change from baseline in Respiratory Rate when placed in upright position
Respiratory stability will be determined by changes from baseline in respiratory rate when participants are placed in an upright position.
Measured: Three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter E Morris, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160561
- Sponsor's protocol ID
- IRB00023156
- Status last verified
- Aug 2018
- First submitted
- 27 May 2014
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strandberg A, Tokics L, Brismar B, Lundquist H, Hedenstierna G. Constitutional factors promoting development of atelectasis during anaesthesia. Acta Anaesthesiol Scand. 1987 Jan;31(1):21-4. doi: 10.1111/j.1399-6576.1987.tb02513.x.
PubMed 3825472
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Upright Bed Position in ARDS Patients
- ClinicalTrials.gov ID
- NCT02160561
- Acronym / sponsor ID
- IRB00023156
- Conditions
- Critical Illness, Acute Respiratory Failure, Adult Syndrome
- Keywords
- mechanical, ventilation, acute, respiratory, failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jun 2014 (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.
Lower lobe atelectasis of the lung is common in Acute Respiratory Distress Syndrome (ARDS) and has the potential to adversely impact lung compliance and intra-pulmonary shunt. The cephalic shift of the diaphragm and dorsal atelectasis associated with the commonly used supine position might also contribute to this shunt. Reports indicate that obese patients may be more likely to develop dorsal atelectasis than non-obese patients.
The investigators hypothesized that opening the body position angle at the waist from a typical head of bed at 30 degrees to one similar to a more upright reverse trendelenburg position, would alter the position of the diaphragm downward, allowing for improved aeration of lung bases. Thus, the investigators examined the upright body positioning in mechanically ventilated patients with ARDS primarily by evaluating for effects on oxyhemoglobin saturation (O2sat), Tidal Volume (TV) and Respiratory Rate (RR).
Detailed description
Acute respiratory failure and acute respiratory distress syndrome is a life-threatening occurrence. The annual incidence of ARDS is 141,500 patients, with 59,000 deaths, and a cost of 1,642,000 hospital days/year. Within this population, special care needs of obese patients are becoming a clinically important entity within the Intensive Care Unit (ICU). ICU literature on body positioning for obese mechanically ventilated patients is limited. Currently, intubated obese patients are placed in the supine position with the head of bed elevated at 30 degrees. The 30 degree head up position has been adopted for all patients as a reflection of the Ventilator Associated Pneumonia prevention literature. In all critically ill patients on mechanical ventilation, a cephalic shift of the diaphragm along with dorsal atelectasis of the lung occurs. In obese patients this alteration may be associated with greater degree of impairment in lung compliance and gas exchange as compared to non-obese ventilated patients. It is possible that current ICU body positioning recommendations for obese mechanically ventilated patients may be detrimental due to the obese abdominal compartment hampering normal diaphragm function and position.
In supine, intubated, mechanically ventilated patients it has long been noted that lower lung lobes become atelectatic soon after intubation due to several factors such as accumulation of fluids, air closure, and a cephalic shift of the diaphragm. Obese patients develop more atelectasis during anesthesia than non-obese patients. There have been attempts to correct this iatrogenic complication in critically ill patients such as placement of patients in the prone position. Prone positioning does resolve the dorsal atelectasis and shows improvement in hypoxia. However there is no mortality benefit with prone positioning. Also, continuous lateral rotational patient positioning on mechanical ventilation has shown similar effects7. Specific literature with regards to obese patients and their unique susceptibility towards this phenomenon is limited.
As BMI increases there is an associated reduction of lung volumes, expiatory reserve volume, and functional reserve capacity. It is also known that in the reverse trendelenburg position, there is a gravitational pull allowing abdominal contents to descent toward the pelvis. This position of the abdominal contents allows for a more functional diaphragm position. One observational study 10 conducted a 12 hour intervention which examined upright position with patients' body in a straight line at 40-45 degrees (i.e., reverse trendelenburg-no bend at the waist). This study demonstrated a significant increase in the PaO2/FiO2 ratio (ie, oxygenation) during upright position.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Intervention ArmExperimental - Intervention Arm patients who are in critical illness with acute respiratory failure and are mechanically ventilated will be placed in an upright reverse trendelenburg position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mechanically ventilated
- Chest radiograph must show parenchymal lung infiltrates.
- Acute Lung Injury
- Study shall occur 96 hours after consent has been obtained
Key exclusion criteria (2 listed)
- Hemodynamic instability and/or use of a vasopressor within the last 6 hours prior to enrollment.
- Pregnant patients.
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 |
|---|---|---|
| Intervention ArmPlacing patients who are in critical illness with acute respiratory failure and are mechanically ventilated in an upright reverse trendelenburg position | Other | Intervention Arm |
Primary outcome
Number of participants with change in hemodynamic stability from baseline when placed in upright position
Time frame: Three hours
Hemodynamic stability will be determined by changes from baseline in blood pressure or heart rate when participants are placed in an upright position.
3 secondary outcomes
Number of participants with change in Oxyhemoglobin Saturation from baseline when placed in upright position
Time frame: Three hours
Number of participants with Change in Tidal Volume from baseline when placed in upright position
Time frame: Three hours
Number of participants with change from baseline in Respiratory Rate when placed in upright position
Time frame: Three hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 3825472Strandberg A, Tokics L, Brismar B, Lundquist H, Hedenstierna G. Constitutional factors promoting development of atelectasis during anaesthesia. Acta Anaesthesiol Scand. 1987 Jan;31(1):21-4. doi: 10.1111/j.1399-6576.1987.tb02513.x.
- Individual participant dataSharing planned: No
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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.
Peter E Morris, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm in people with Critical Illness and Acute Respiratory Failure, run by Wake Forest University Health Sciences 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 2 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: finished, as of the sponsor's last update on 9 Aug 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with change in hemodynamic stability from baseline when placed in upright position (time frame: Three hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02160561, which also lists 1 linked publication.
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 9 Aug 2018.