Awake Prone Positioning for Non-intubated COVID-19 Patients

NCT04760561 | Completed

• 1 other identifier: Proning for COVID-19 Patients
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The burden of coronavirus disease 2019 (COVID-19) pandemic is still on a rising course making a great stress on medical resources throughout the world. Although most of COVID-19 patients require non-invasive oxygenation and ventilation, rapid progression to hypoxemic respiratory failure and then acute respiratory distress syndrome (ARDS) can occur in some COVID19 patients due to prolonged or unaddressed hypoxia. Prone positioning is a common supportive ventilation strategy to improve oxygenation in critically ill patients with ARDS. Recent studies point out the potential benefits of using this strategy for non-intubated awake COVID 19 patients who are hypoxic. Despite several retrospective cohort studies have been conducted to identify impact of the prone positioning in awake non-intubated COVID-19 patients, experimental studies are very rare. This study therefore aims to evaluate the effects of self-prone positioning on oxygenation and physiological outcomes among awake-non intubated patients with COVID-19.

Conditions

Prone Position; Coronavirus Disease 2019; Oxygenation

Outcome Measures

Primary Outcomes (11)

• Oxygenation index

  arterial oxygen pressure/fractional inspired oxygen PaO2/FiO2 ratio mmHg.

  Change in the value immediately before, after 10 minutes and after 1hour of patient positioning

• SpO2

  Peripheral oxygen saturation

  Change in the value immediately before, after 10 minutes and after 1hour of patient positioning.

• ROX index

  combination of the ratio of oxygen saturation measured by pulse oximetry to fraction of inspired ox¬ygen and respiratory rate (\[SpO2/FiO2\]/respiratory rate)

  Change in the value immediately before and after 1hour of patient positioning.

• PaO2mmHg

  Partial pressure of oxygen within arterial blood

  change in the value immediately before and after 1hour of patient positioning.

• PCO2mmHg

  The partial pressure of carbon dioxide within arterial blood

  change in the value immediately before and after 1hour of patient positioning.

• SaO2

  Oxygen saturation (SaO2) is a measurement of the percentage of how much hemoglobin is saturated with oxygen.

  change in the value immediately before and after 1hour of patient positioning.

• pH

  The acidity or alkalinity of blood.

  change in the value immediately before and after 1hour of patient positioning.

• Respiratory Rate (RR) (bpm)

  the number of breaths a person takes per minute.

  change in the value immediately before, after 10 minutes and after 1hour of patient positioning.

• Heart Rate (HR) (bpm)

  is the the speed of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm)

  change in the value immediately before, after 10 minutes and after 1hour of patient positioning.

• Blood Pressure (BP) mmHg

  is the the pressure of circulating blood against the walls of blood vessels.

  change in the value immediately before, after 10 minutes and after 1hour of patient positioning.

• Positive response to prone positioning

  defined as a 10% increase in PaO2/FiO2 ratio or 10% decrease in respiratory rate

  Time Frame: change in the value of PaO2/FiO2 ratio or respiratory rate after 1hour of patient positioning

Secondary Outcomes (1)

• Prone position adverse events

  appearance of events from 10 minutes after patient positioning up to 3hours after patient positioning..

Study Arms (2)

Control group (conventional care)

NO INTERVENTION

Patients randomized to this arm will receive the conventional positioning interventions provided by the critical care nurses, which will not include self-prone positioning.

Intervention group (prone position group)

EXPERIMENTAL

Patients randomized to this arm will receive self-prone positioning.

Procedure: prone position group

Interventions

prone position group PROCEDURE

Patients randomized to this arm will receive self-prone positioning. Each patient in the intervention group will be helped into the prone position and encouraged to stay in the prone position as long as tolerated (at least 1 hour). The prone positioning consists of placing the patient on his or her stomach with the head on the side. Self-prone position will be performed 45 minutes up to 1 hour after meals to avoid gastrointestinal side effects. The patient will be maintained in prone position until the patient becomes too tired and uncomfortable to keep that position. If patients will asked to regain the supine position before the 1 hour period was complete, patient's prone position will be considered unfeasible and the reason will be reported. Patients who required invasive mechanical ventilation at any time point will be intubated and excluded from the study.

Intervention group (prone position group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years old
• Awake non-intubated spontaneously breathing patients
• Confirmed diagnosis of severe COVID-19; manifesting as dyspnea with respiratory rate ≥ 30 breaths/min, pulse rate ≥ 100 beats/min, oxygen saturation ≤93%, or partial pressure of arterial oxygen (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 150 mmHg.
• Positive RT-PCR for SARS-CoV-2 from analysis of nasopharyngeal, oropharyngeal swab, or tracheal secretion specimens and with chest X-ray showing bilateral infiltrations or chest computerized tomographic (CT) images showing exudation or consolidation.
• Requiring supplemental oxygen (nasal cannula, non-invasive CPAP, non-rebreathing face mask)
• Capable of adopting a prone posture independently.

You may not qualify if:

• The presence of any of the following will mean patients are ineligible:
• life-threatening arrhythmias
• Hemodynamic instability (defined as mean arterial pressure \[MAP\] \< 65mm Hg and use of vasopressors to achieve MAP \> 65 mm Hg)
• Altered mental status, intracranial hypertension
• Facial injuries
• Spine or pelvic fractures
• Recent abdominal surgery
• Pregnancy
• Altered mental status and patients needing invasive ventilation.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Faculty of nursing

Alexandria, 02225585888, Egypt

Location

Related Publications (6)

• Binda F, Marelli F, Galazzi A, Pascuzzo R, Adamini I, Laquintana D. Nursing Management of Prone Positioning in Patients With COVID-19. Crit Care Nurse. 2021 Apr 1;41(2):27-35. doi: 10.4037/ccn2020222.

  PMID: 33341885 BACKGROUND

• Dubosh NM, Wong ML, Grossestreuer AV, Loo YK, Sanchez LD, Chiu D, Leventhal EL, Ilg A, Donnino MW. Early, awake proning in emergency department patients with COVID-19. Am J Emerg Med. 2021 Aug;46:640-645. doi: 10.1016/j.ajem.2020.11.074. Epub 2020 Dec 3.

  PMID: 33309507 BACKGROUND

• Flynn Makic MB. Prone Position of Patients With COVID-19 and Acute Respiratory Distress Syndrome. J Perianesth Nurs. 2020 Aug;35(4):437-438. doi: 10.1016/j.jopan.2020.05.008. Epub 2020 May 30. No abstract available.

  PMID: 32741521 BACKGROUND

• Solverson K, Weatherald J, Parhar KKS. Tolerability and safety of awake prone positioning COVID-19 patients with severe hypoxemic respiratory failure. Can J Anaesth. 2021 Jan;68(1):64-70. doi: 10.1007/s12630-020-01787-1. Epub 2020 Aug 14.

  PMID: 32803468 BACKGROUND

• Sztajnbok J, Maselli-Schoueri JH, Cunha de Resende Brasil LM, Farias de Sousa L, Cordeiro CM, Sansao Borges LM, Malaque CMSA. Prone positioning to improve oxygenation and relieve respiratory symptoms in awake, spontaneously breathing non-intubated patients with COVID-19 pneumonia. Respir Med Case Rep. 2020;30:101096. doi: 10.1016/j.rmcr.2020.101096. Epub 2020 May 19.

  PMID: 32455107 BACKGROUND

• Cotton S, Zawaydeh Q, LeBlanc S, Husain A, Malhotra A. Proning during covid-19: Challenges and solutions. Heart Lung. 2020 Nov-Dec;49(6):686-687. doi: 10.1016/j.hrtlng.2020.08.006. Epub 2020 Aug 19.

  PMID: 32861885 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sahar Y Othman, A/P.

  Faculty of Nursing, Damanhour University

  PRINCIPAL INVESTIGATOR

• Alaa M Mohamed, Lect.

  Faculty of Nursing, Damanhour University

  STUDY DIRECTOR

• Ahmed M El-Menshawy, Lect.

  University of Alexandria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Experimental research design

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: February 20, 2021
• Primary Completion: March 20, 2021
• Study Completion: April 20, 2021
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

EG (1)