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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000045889
Receipt No. R000052387
Scientific Title Adaptive, multicenter, randomized, controlled, open trial of the use of early prone positioning in conscious patients with severe COVID-19 without invasive ventilatory support, to prevent invasive mechanical ventilation and death.
Date of disclosure of the study information 2021/10/27
Last modified on 2021/10/28

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Basic information
Public title Early awake prone positioning combined with non-invasive oxygen therapy in patients with COVID-19
Acronym APPearl
Scientific Title Adaptive, multicenter, randomized, controlled, open trial of the use of early prone positioning in conscious patients with severe COVID-19 without invasive ventilatory support, to prevent invasive mechanical ventilation and death.
Scientific Title:Acronym Adaptive, multicenter, randomized, controlled, open trial of the use of early prone positioning in conscious patients with severe COVID-19 without invasive ventilatory support, to prevent invasive mechanical ventilation and death (APPearl)
Region
North America South America

Condition
Condition COVID-19, acute hypoxemic respiratory failure
Classification by specialty
Pneumology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of early awake prone positioning in patients with acute hypoxemic respiratory failure due to coronavirus disease (COVID-19) under non-invasive oxygen therapy to prevent intubation and mortality
Basic objectives2 Others
Basic objectives -Others To evaluate safety and tolerance to awake prone positioning in patients with acute hypoxemic respiratory failure due to coronavirus disease (COVID-19) under non-invasive oxygen therapy, probability of transtition and occupation of 4 clinical states (non-invasive oxygen therapy, invasive mechanical ventilation, domiciliary discharge, and death), and improvement of oxygenation parameters.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1. Proportion of patients with orotracheal intubation and invasive mechanical ventilation performed up to 28 days after randomization.
2. Proportion of patients who die up to 28 days after randomization.
Key secondary outcomes 1. Probability of transition and occupation of 4 clinical states (non-invasive oxygen therapy, invasive mechanical ventilation, domiciliary discharge, and death) up to day 28 after randomization.
2. Proportion of patients achieving a SpO2/FiO2 greater than or equal to 236 for at least 12 hours within 28 days after randomization.
3. Proportion of patients achieving the greater than or equal to 12 hours/day in the prone position during the duration of the intervention, up to 28 days after randomization
4. SpO2/FiO2 index at different times (Baseline, 1 hour, 6 hours, 24 hours, 48 hours, and 72 hours).
5. Proportion of patients with complications potentially associated to prone position (accidental vascular access dislodgement, vomit, falls, pressure lesions, and intolerance to prone position) up to 28 days after randomization
6. Proportion of patients who develop acute respiratory distress syndrome (up to 28 days after randomization).
7. Proportion of patients with de novo organic failure during hospital stay (up to 28 days after randomization).
8. Time (days) of hospital stay (up to 28 days after randomization).
9. Time (days) of stay in the intensive care unit (up to 28 days after randomization).
10. Total time (days) of invasive mechanical ventilation (up to 28 days after randomization).
11. Total time (days) of ventilator-free days (up to 28 days after randomization).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention - Awake prone positioning.
The intervention consists of self- or assisted positioning in the decubitus recumbent prone position (bed header at 0 grades) for as much as possible, with the possibility to alternate between complete prone position for 30 min to 2 hours, followed by lateral prone position for 30 min to 2 hours, followed by supine position (bed header 30-60 grades), followed by lateral prone position for 30 min to 2 hours, ending the cycle with 30 min to 2 hours in the prone position. These cycles are intended to increase patient comfort and can be repeated as many times as possible. Time in every position will be quantified.
The intervention will be performed until the patient achieves a SpO2/FiO2 index greater than or equal to 235 with an oxygen device providing inspired oxygen fraction (FiO2) lower than 40%, for 12 continuous hours. If this happens, it will be considered as therapeutic success and the patient will be asked to interrupt prone positioning. If the patient does not meet these criteria during the 28-day follow-up, it will be considered as treatment failure. If the patient undergoes orotracheal intubation and invasive mechanical ventilation, it will also be considered as treatment failure and prone positioning will be performed unless the patient has contraindications hemodynamic instability.
Interventions/Control_2 Control - Supine recumbent position.
Patients in the control group will be encouraged to remain in the decubitus recumbent supine position (bed header 30-60 grades) for as much as possible. Patients will be able to freely choose any other position. The number of hours spent in all positions will be quantified, including lateral and complete prone positions. Patients in the control group will not be advised to follow the positioning cycle described for the intervention group.
If the patient achieves a SpO2/FiO2 index greater than or equal to 235 with an oxygen device providing inspired oxygen fraction (FiO2) lower than 40%, for 12 continuous hours, the patient will no longer be encouraged to remain in the supine recumbent position and this will be considered as success in the supine position.
If the patient does not meet these criteria during the 28-day follow-up, it will be considered as failure. If the patient undergoes orotracheal intubation and invasive mechanical ventilation, it will also be considered as failure and prone positioning will be performed unless the patient has hemodynamic instability.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient hospitalized in non-critical wards, with at least 12 hours of hospital stay but no longer than 48 hours at the moment of randomization.
2. Severe COVID-19 according to the following criteria:
a. Symptoms of COVID-19, with 1 or more of the following
i. Tachypnea (greater than or equal to 30 breaths per minute)
ii. Peripheral oxygen saturation (SpO2) at room air (FiO2 21%) lower than or equal to 93% at sea level (lower than or equal to 89% in Mexico City) at any moment of current hospitalization.
iii. PaO2/FiO2 ratio <300
iv. Pulmonary infiltrates >50% in imaging study performed in the last 24 to 48 hours.
3. Oxygen therapy with a device providing a FiO2 greater than or equal to 40%
a. Low-flow nasal cannula with at least 5 liters per minute.
b. Non-rebreather mask
c. High-flow nasal cannula without imminent requirement of orotracheal intubation (ROX index greater than or equal to 4.88)
4. The participant understands the intervention, randomization, follow-up and provides their written informed consent prior to randomization.
Key exclusion criteria 1. Patients in palliative care
2. Patients with imminent orotracheal intubation according to refractory hypoxemia with acute respiratory distress syndrome (ARDS), acute respiratory acidosis (pH < 7.15, PaCO2 >45 mmHg) with ARDS, requirement of airway protection.
3. Patients with unsolved shock (reanimation phase or norepinephrine dose greater than or equal to 0.15 mcg/kg/min).
4. Unstable arrythmias (bradycardia o tachycardia).
5. Mental agitation or altered mental state (Glasgow Comma Scale <10 points) that would impede cooperation to self-prone.
6. Instability of the pelvis, vertebral column, or femur due to recent surgery or trauma.
7. Anatomical alterations that limit the adoption of prone position (severe kyphoscoliosis, muscle contracture, or other).
8. Abdominal surgery in the last 15 days.
9. Thoracic lesion or surgery in the last 15 days.
10. Pregnancy
11. Intracranial hypertension
12. Deep vein thrombosis in the last 2 days.
13. Heart pacemaker surgery in the last 2 days.
14. Chest tube with air leak
15. Recent facial trauma or surgery
16. Morbid obesity (BMI >40 kg/m2)
17. Pressure lesions or ulcers
Target sample size 384

Research contact person
Name of lead principal investigator
1st name Jose
Middle name de Jesus
Last name Vidal-Mayo
Organization Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Division name Intensive Care Unit
Zip code 14080
Address Av. Vasco de Quiroga 15, Col. Belisario Dominguez Seccion XVI, Tlalpan 14080, Mexico City, Mexico
TEL +52(55)55737378
Email interstrok@hotmail.com

Public contact
Name of contact person
1st name Jose
Middle name de Jesus
Last name Vidal-Mayo
Organization Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Division name Intensive Care Unit
Zip code 14080
Address Av. Vasco de Quiroga 15, Col. Belisario Dominguez Seccion XVI, Tlalpan 14080, Mexico City, Mexico
TEL +52(55)48158075
Homepage URL https://www.incmnsz.mx/opencms/
Email interstrok@hotmail.com

Sponsor
Institute Mexican Secretariat of Health
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Intensive Care Unit
Institute
Department

Funding Source
Organization Mexican Secretariat of Health
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Intensive Care Unit
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Mexican

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research and Ethics Committee of the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Address Av. Vasco de Quiroga 15, Col. Belisario Dominguez Seccion XVI, Tlalpan 14080, Mexico City, Mexico
Tel +52(55)55737378
Email sergio.hernandez@incmnsz.mx

Secondary IDs
Secondary IDs YES
Study ID_1 U1111-1270-7262
Org. issuing International ID_1 Universal Trial Number - World Health Organization
Study ID_2 SME-3394-20-20-1
Org. issuing International ID_2 Research and Ethics Committee of the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 27 Day

Related information
URL releasing protocol https://www.protocols.io/view/appearl-protocolo-v1-0-bs5dng26
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 09 Day
Date of IRB
2021 Year 03 Month 12 Day
Anticipated trial start date
2021 Year 09 Month 02 Day
Last follow-up date
2023 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 10 Month 27 Day
Last modified on
2021 Year 10 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052387

Research Plan
Registered date File name

Research case data specifications
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Research case data
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