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TerminatedNCT06076109Updated Oct 10, 2023

Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19.

An interventional study of Prone position and Standard treatment in COVID-19 Pneumonia, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Terminated at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Not applicable, Interventional, and Treatment

Why this study was terminated
We do not have more subjects to enter into the study.

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Mar 2021, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
137
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • COVID-19 Pneumonia
03

In context

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 144 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - 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
    • 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

Exclusion criteria

Exclusion Criteria:

  • 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
      • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
137 participants (actual)

Study arms

  • Active comparator
    PRONE POSITION

    Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the prone position.

    Other: Prone position

  • Placebo comparator
    STANDARD TREATMENT

    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.

    Other: Standard treatment

Interventions

  • OtherProne position

    Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the prone position.

  • OtherStandard treatment

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 days

07

Study locations

1 site
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
    Mexico City, 16310, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06076109
Responsible party
Thierry Hernández Gilsoul (Head of department, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran) — Principal investigator
First posted
Oct 10, 2023
Start date
Mar 1, 2021
Primary completion
Mar 31, 2022
Completion
Apr 30, 2022
Last update
Oct 10, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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