Incline Positioning in COVID-19 Patients for Improvement in Oxygen Saturation

NCT04344561 | Terminated DMC

• 1 other identifier: IRB00246834
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. A portion of individuals with COVID-19 experience life-threatening hypoxia requiring supplemental oxygen and mechanical ventilation. Management of hypoxia in this population is complicated by contraindication of non-invasive ventilation and limitations in access to mechanical ventilation and critical care staff given the clinical burden of disease. Positional therapy is readily deployable and may ultimately be used to treat COVID-19 related respiratory failure in resources limited settings; and, it has been demonstrated to improve oxygenation and is easy to implement in the clinical setting. The overall goal of this randomized controlled trial is to establish the feasibility of performing a randomized trial using a simple, minimally invasive positional therapy approach to improve hypoxia and reduce progression to mechanical ventilation. The objectives are to examine the effectiveness and feasibility of maintaining an inclined position in patients with confirmed or suspected COVID-19 associated hypoxemic respiratory failure. The investigators hypothesize that (1) oxyhemoglobin saturation will improve with therapy, (2) participants will tolerate and adhere to the intervention, and that (3) participants who adhere to positional therapy will have reduced rates of mechanical ventilation at 72 hours. If successful, this feasibility trial will demonstrate that a simple, readily deployed nocturnal postural maneuver is well tolerated and reverses underlying defects in ventilation and oxygenation due to COVID-19. It will also inform the design of a pivotal Phase III trial with estimates of sample sizes for clinically relevant outcomes.

Conditions

COVID; Hypoxic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Incidence of Mechanical Ventilation

  Number of participants needing mechanical ventilation over total number of participants per arm.

  72 hours

Secondary Outcomes (6)

• Number of participants with supplemental oxygen requirements

  72 hours

• Mean oxyhemoglobin saturation

  At 24, 48 and 72 hours

• Mean Nocturnal Oxyhemoglobin Saturation

  Measured between 10pm and 6am daily, up to 72 hours

• Heart Rate

  At 10, 24, 48 and 72 hours

• Respiratory Rate

  At 10, 24, 48 and 72 hours

Other Outcomes (1)

• Acute change in oxyhemoglobin saturation

  During the final 7 minutes at each position, up to 72 hours

Study Arms (2)

Postural Positioning

EXPERIMENTAL

Participants in the group will have hospital beds placed in 15 degree (reverse Trendelenburg).

Other: Postural Positioning

Standard Care

NO INTERVENTION

Participants in this group will have beds managed per standard nursing protocol.

Interventions

Postural Positioning OTHER

Investigators will adjust the positioning of hospital beds to assess improvements in oxygenation and respiratory status.

Postural Positioning

Eligibility Criteria

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

You may qualify if:

• COVID-19 positive
• Pneumonia defined as hospitalization for acute (\< 7 days) onset of symptoms (cough, sputum production, or dyspnea).
• Hypoxemia defined as ≥ 2 L/min oxygen

You may not qualify if:

• Intubation
• Inability to lie supine

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Bayview Hospital

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (15)

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Study Officials

• Luu Pham, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: May 25, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)