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Feasibility of Upright Bed Position in ARDS Patients

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ClinicalTrials.gov Identifier: NCT02160561
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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 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).


Condition or disease Intervention/treatment Phase
Critical Illness Acute Respiratory Failure Adult Syndrome Other: Intervention Arm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of Upright Bed Position in ARDS Patients
Study Start Date : April 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm
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
Other: Intervention Arm
Placing patients who are in critical illness with acute respiratory failure and are mechanically ventilated in an upright reverse trendelenburg position




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of participants with change in Oxyhemoglobin Saturation from baseline when placed in upright position [ Time Frame: Three hours ]
    Oxyhemoglobin saturation levels will be monitored when participant is placed in upright position. Change from baseline level will be recorded.

  2. Number of participants with Change in Tidal Volume from baseline when placed in upright position [ Time Frame: Three hours ]
    Tidal volume will be monitored when participant is placed in upright position. Change from baseline level will be recorded.

  3. Number of participants with change from baseline in Respiratory Rate when placed in upright position [ Time Frame: Three hours ]
    Respiratory stability will be determined by changes from baseline in respiratory rate when participants are placed in an upright position.


Other Outcome Measures:
  1. Number of participants with change from baseline in respiratory system compliance when placed in upright position [ Time Frame: Three hours ]
    Respiratory System Compliance will be determined by changes from baseline in anxiety level and ventilation requirements when participants are placed in an upright position. Participants will be continually monitored and observed to note changes in anxiety on a comfort scale as well as any mechanical ventilator changes to mode, rate, and delivered oxygen percents required for comfort.



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

Inclusion Criteria:

  • Mechanically ventilated
  • Chest radiograph must show parenchymal lung infiltrates.
  • Acute Lung Injury
  • Study shall occur 96 hours after consent has been obtained

Exclusion Criteria:

  • Hemodynamic instability and/or use of a vasopressor within the last 6 hours prior to enrollment.
  • Pregnant patients.

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): NCT02160561


Locations
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United States, North Carolina
Wake Forest Baptist Health, Medical Intensive Care Unit
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Peter E Morris, MD Wake Forest University Health Sciences
Publications:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02160561    
Other Study ID Numbers: IRB00023156
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
mechanical
ventilation
acute
respiratory
failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Critical Illness
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes