Feasibility of Upright Bed Position in ARDS Patients

NCT02160561 | Completed DMC

• 1 other identifier: IRB00023156
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness; Acute Respiratory Failure; Adult Syndrome

Keywords

mechanical; ventilation; acute; respiratory; failure

Outcome Measures

Primary Outcomes (1)

• 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.

  Three hours

Secondary Outcomes (3)

• Number of participants with change in Oxyhemoglobin Saturation from baseline when placed in upright position

  Three hours

• Number of participants with Change in Tidal Volume from baseline when placed in upright position

  Three hours

• Number of participants with change from baseline in Respiratory Rate when placed in upright position

  Three hours

Other Outcomes (1)

• Number of participants with change from baseline in respiratory system compliance when placed in upright position

  Three hours

Study Arms (1)

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

Other: Intervention Arm

Interventions

Intervention Arm OTHER

Placing patients who are in critical illness with acute respiratory failure and are mechanically ventilated in an upright reverse trendelenburg position

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health, Medical Intensive Care Unit

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 3825472 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Propping Zerres syndrome; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Peter E Morris, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 10, 2014
• Study Start: April 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)