Clinical trial NCT04760561: Awake Prone Positioning for Non-intubated COVID-19 Patients
Official title: Effects of Awake Prone Positioning on Oxygenation and Physiological Outcomes in Non-intubated COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prone Position
Coronavirus Disease 2019
Oxygenation
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental research design
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: A randomised controlled trial design will be adopted to achieve the aim of the current study. In this study 82 adult patients of either sex with a confirmed diagnosis of COVID-19 will be recruited from general intensive care unit of the chest hospital (affiliated to the Ministry of Health) in Damanhour city, El Beheira Governorate, Egypt. Patients will be enrolled in the current study if they meet study inclusion criteria.

The eligible patients will be randomly assigned into two groups (control and intervention group) 41 patients in each. The control group will receive the standard management of COVID-19 patients according to the Egyptian Ministry of health guidelines. The standard management includes supplemental oxygen or non-invasive continuous positive airway pressure (CPAP), antivirals, antibiotics, anticoagulants and glucocorticoids, as necessary, based on the patients' clinical condition. Patients in the control group will be subjected to the conventional positioning interventions provided by the critical care nurses, which will not include self-prone positioning.

Patients in the intervention group will receive self-prone positioning and standard management of COVID-19 patients. All patients in both groups (control and intervention) will be monitored continuously by cardiac monitoring with oxygen saturation (SpO2) during the study period. The demographic and baseline clinical data of all eligible patients will collected and recorded using the study tool.

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.

The effect of patients' positioning on oxygenation and physiological parameters will be collected and recorded. These parameters include vital signs (respiratory rate, systolic blood pressure, diastolic blood pressure and heart rate), SpO2, oxygenation index (PaO2/FiO2 ratio), ROX index (combination of the ratio of oxygen saturation measured by pulse oximetry to fraction of inspired oxygen and respiratory rate \[SpO2/FiO2\]/respiratory rate) and arterial blood gases parameters (pH, PaO2mmHg, PaCO2mmHg and SaO2). These parameters will be recorded before and after positioning (immediately before, after 10 minutes and after 1hour). Data of secondary outcomes of self-prone positioning will also be collected and recorded.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-75 years old
2. Awake non-intubated spontaneously breathing patients
3. 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.
4. 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.
5. Requiring supplemental oxygen (nasal cannula, non-invasive CPAP, non-rebreathing face mask)
6. Capable of adopting a prone posture independently.

Exclusion Criteria:

The presence of any of the following will mean patients are ineligible:

1. life-threatening arrhythmias
2. Hemodynamic instability (defined as mean arterial pressure \[MAP\] \< 65mm Hg and use of vasopressors to achieve MAP \> 65 mm Hg)
3. Altered mental status, intracranial hypertension
4. Facial injuries
5. Spine or pelvic fractures
6. Recent abdominal surgery
7. Pregnancy
8. Altered mental status and patients needing invasive ventilation.

Primary outcomes:
measure: Oxygenation index
timeFrame: Change in the value immediately before, after 10 minutes and after 1hour of patient positioning
measure: SpO2
timeFrame: Change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
measure: ROX index
timeFrame: Change in the value immediately before and after 1hour of patient positioning.
measure: PaO2mmHg
timeFrame: change in the value immediately before and after 1hour of patient positioning.
measure: PCO2mmHg
timeFrame: change in the value immediately before and after 1hour of patient positioning.
measure: SaO2
timeFrame: change in the value immediately before and after 1hour of patient positioning.
measure: pH
timeFrame: change in the value immediately before and after 1hour of patient positioning.
measure: Respiratory Rate (RR) (bpm)
timeFrame: change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
measure: Heart Rate (HR) (bpm)
timeFrame: change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
measure: Blood Pressure (BP) mmHg
timeFrame: change in the value immediately before, after 10 minutes and after 1hour of patient positioning.
measure: Positive response to prone positioning
timeFrame: Time Frame: change in the value of PaO2/FiO2 ratio or respiratory rate after 1hour of patient positioning
Secondary outcomes:
measure: Prone position adverse events
timeFrame: appearance of events from 10 minutes after patient positioning up to 3hours after patient positioning..
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of nursing
Study officials:
affiliation: Faculty of Nursing, Damanhour University
name: Sahar Y Othman, A/P.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Nursing, Damanhour University
name: Alaa M Mohamed, Lect.
role: STUDY_DIRECTOR
affiliation: University of Alexandria
name: Ahmed M El-Menshawy, Lect.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.