Viewing Study NCT06076109



Ignite Creation Date: 2024-05-06 @ 7:36 PM
Last Modification Date: 2024-10-26 @ 3:10 PM
Study NCT ID: NCT06076109
Status: TERMINATED
Last Update Posted: 2023-10-10
First Post: 2023-10-09

Brief Title: Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Overview

Official Title: Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19 APPearl
Status: TERMINATED
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: We do not have more subjects to enter into the study
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 30-60ยบ 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 SpO2FiO2 on admission and at 1 6 12 24 48 and 72 hours after inclusion in the protocol as well as PaO2FiO2 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None