COVID-19 PneumoniaNCT06076109
Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19.
A study testing Prone position and Standard treatment in people with COVID-19 Pneumonia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Introduction: The disease caused by the new coronavirus (COVID-19) represents a pandemic with significant affectation in our country, generating critical illness in around 5% of the patients who present this disease at an international level, with the requirement of invasive mechanical ventilation being the main cause… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Prone position and Standard treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age greater than or equal to 18 years at the time of the initial evaluation.
- Patient hospitalized in non-critical areas, with at least 12 hours and no more than 48 hours of hospital stay at the time of randomization with a clinical picture of severe COVID-19, according to the following:
- o Patient with symptoms of COVID-19, who meets ≥1 of the following criteria:
- Tachypnea (≥30 breaths per minute)
- Arterial oxygen saturation (SaO2) in ambient air (FiO2 21%) less than or equal to 93% at sea level (89% in Mexico City), with supplemental oxygen requirements ≥4 liters per minute.
- Arterial pressure ratio of Oxygen and Fraction of Inspired Oxygen (PaFi) <300
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- Pulmonary infiltrates in imaging study covering >50% of lung fields, within the last 24 to 48 hours.
- Administration of supplemental oxygen through a device that provides FiO2 ≥40% (nasal cannulas at a flow of 5 liters or reservoir mask
- The participant understands and agrees with the intervention, randomization and follow-up that will be given during hospitalization and after discharge home and signs the informed consent document prior to randomization
Who cannot join
- The patient does not wish to participate in the study
- Patients in palliative care
- Patients with an indication for orotracheal intubation defined by the presence of at least 2 of the following criteria:
- Refractory hypoxemia (SaO2 <90% or PaO2 ≤60% with an oxygenation device providing FiO2 ≥60%) for ≥5 minutes without technical failure of the monitoring or oxygenation device
- Respiratory rate ≥35 breaths per minute
- Persistent clinical signs of respiratory fatigue: use of accessory muscles of respiration and thoraco-abdominal dissociation
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- acute respiratory acidosis (PH ≤ 7.25, PaCO2 >45 mmHg)
- abundant respiratory secretions with inability for adequate expectoration by the patient or OR indication for orotracheal intubation due to the presence of 1 of the following criteria:
- Airway protection requirement: acute altered mental status (ECG <10 points) with absence of airway protection reflexes, active hemoptysis or hematemesis, or airway obstruction. Patients with hypoxemic respiratory failure presenting state unresolved shock (need for resuscitation with intravenous fluids and/or requirement for administration of vasopressors), and unstable arrhythmias (bradycardia or tachycardia)
- Patients with unresolved shock (resuscitation phase or norepinephrine dose ≥0.15 mcg/kg/min), and unstable arrhythmias (bradycardia or tachycardia).
- Agitation or acute alteration of the mental state (ECG <10 points) that do not allow the cooperation of the patient for his mobilization to the prone position
- Instability of the pelvis, spine, or femur from recent surgery or trauma
- Anatomical alterations that limit the adoption of the prone position (severe xiphoscoliosis, contractures in the extremities, other alterations).
- Abdominal surgery in the last 15 days
- Chest injury or chest surgery in the last 15 days or Pregnancy or intracranial hypertension
- Deep vein thrombosis in the last 2 days
- Cardiac pacemaker placement in the last 2 days
- Chest tube with air leak or recent facial trauma or surgery
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 16310
About this study
Official title: Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19 (APPearl).
Introduction: The disease caused by the new coronavirus (COVID-19) represents a pandemic with significant affectation in our country, generating critical illness in around 5% of the patients who present this disease at an international level, with the requirement of invasive mechanical ventilation being the main cause of admission to intensive care units (UTI).
Objective: to evaluate the utility of using the prone position in patients with hypoxemic respiratory failure with COVID-19 who are with non-invasive oxygenation devices to reduce the need for invasive mechanical ventilation and mortality in this population.
Material and methods: a controlled and randomized clinical trial will be carried out, which will include patients who come to the institution for medical attention with a confirmed or suspected diagnosis of COVID-19 with a severe presentation, hypoxemic respiratory failure, and non-existent oxygen therapy. invasive with a FiO2 contribution ≥40%. The patients enter 2 follow-up groups: an intervention group in which the prone position maneuver performed by the patient himself will be implemented, and another group where the patients will remain supine with the head of their bed between 30-60º. The demographic and clinical variables of these patients will be described. The primary outcome to be evaluated will be the proportion of patients requiring orotracheal intubation during their hospital stay. The secondary outcomes that will be evaluated will be hospital mortality, development of ARDS, and changes in oxygenation by determining SpO2 and SpO2/FiO2 on admission and at 1, 6, 12, 24, 48, and 72 hours after inclusion in the protocol. , as well as PaO2/FiO2 on admission and at 24 hours; the time interval between inclusion in the protocol and orotracheal intubation, use of non-invasive ventilatory therapies, days of hospital stay, days of stay in intensive care, days free of mechanical ventilation, development of acute organ failure during hospitalization and complications related to the treatment with the prone position.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Prone position, Standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionOther
Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the prone position.
Standard treatmentOther
Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the supine position with the head of the bed between 30-60º.
| Study group | Role | What they receive |
|---|---|---|
| PRONE POSITION | Active comparator | Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the prone position. Receives: Other: Prone position |
| STANDARD TREATMENT | Placebo comparator | Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the supine position with the head of the bed between 30-60º. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orotracheal intubation and invasive mechanical ventilation at 28 days.
The proportion of patients requiring orotracheal intubation and invasive mechanical ventilation at 28 days post-randomization, as well as the proportion of patients who die within this post-randomization time interval.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Mar 2021
- Primary completion31 Mar 2022
- Study completion30 Apr 2022
Why it stopped: We do not have more subjects to enter into the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thierry Hernández Gilsoul, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076109
- Sponsor's protocol ID
- Appearl
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19 (APPearl).
- ClinicalTrials.gov ID
- NCT06076109
- Acronym / sponsor ID
- Appearl
- Conditions
- COVID-19 Pneumonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We do not have more subjects to enter into the study.
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: The disease caused by the new coronavirus (COVID-19) represents a pandemic with significant affectation in our country, generating critical illness in around 5% of the patients who present this disease at an international level, with the requirement of invasive mechanical ventilation being the main cause of admission to intensive care units (UTI).
Objective: to evaluate the utility of using the prone position in patients with hypoxemic respiratory failure with COVID-19 who are with non-invasive oxygenation devices to reduce the need for invasive mechanical ventilation and mortality in this population.
Material and methods: a controlled and randomized clinical trial will be carried out, which will include patients who come to the institution for medical attention with a confirmed or suspected diagnosis of COVID-19 with a severe presentation, hypoxemic respiratory failure, and non-existent oxygen therapy. invasive with a FiO2 contribution ≥40%. The patients enter 2 follow-up groups: an intervention group in which the prone position maneuver performed by the patient himself will be implemented, and another group where the patients will remain supine with the head of their bed between 30-60º. The demographic and clinical variables of these patients will be described. The primary outcome to be evaluated will be the proportion of patients requiring orotracheal intubation during their hospital stay. The secondary outcomes that will be evaluated will be hospital mortality, development of ARDS, and changes in oxygenation by determining SpO2 and SpO2/FiO2 on admission and at 1, 6, 12, 24, 48, and 72 hours after inclusion in the protocol. , as well as PaO2/FiO2 on admission and at 24 hours; the time interval between inclusion in the protocol and orotracheal intubation, use of non-invasive ventilatory therapies, days of hospital stay, days of stay in intensive care, days free of mechanical ventilation, development of acute organ failure during hospitalization and complications related to the treatment with the prone position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRONE POSITION | Active comparator | Other: Prone positionPatients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the prone position. |
| STANDARD TREATMENT | Placebo comparator | Other: Standard treatmentPatients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the supine position with the head of the bed between 30-60º. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - Age greater than or equal to 18 years at the time of the initial evaluation.
- Patient hospitalized in non-critical areas, with at least 12 hours and no more than 48 hours of hospital stay at the time of randomization with a clinical picture of severe COVID-19, according to the following:
- The participant understands and agrees with the intervention, randomization and follow-up that will be given during hospitalization and after discharge home and signs the informed consent document prior to randomization
Key exclusion criteria (18 listed)
- The patient does not wish to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone positionPatients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the prone position. | Other | PRONE POSITION |
| Standard treatmentPatients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the supine position with the head of the bed between 30-60º. | Other | STANDARD TREATMENT |
Primary outcome
Orotracheal intubation and invasive mechanical ventilation at 28 days.
Time frame: 28 days
The proportion of patients requiring orotracheal intubation and invasive mechanical ventilation at 28 days post-randomization, as well as the proportion of patients who die within this post-randomization time interval.
Results and safety
The study was stopped early (reason given: We do not have more subjects to enter into the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position and Standard treatment in people with COVID-19 Pneumonia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We do not have more subjects to enter into the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orotracheal intubation and invasive mechanical ventilation at 28 days. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.