Clinical Trials Logo

Clinical Trial Summary

The hypothesis of the present study is that the use of Continuous Positive Airway Pressure (CPAP) plus PS can accelerate the weaning process and, consequently, shorten the MV. This multicenter, pragmatic clinical trial aims to compare the use of CPAP + PS versus SIMV + PS as a method for ventilatory weaning of children, emphasizing the duration of the process. There are no similar studies in the world.


Clinical Trial Description

Mechanical ventilation (MV) is a widely used practice among Pediatric Intensive Care Units (PICUs) throughout the world. Data from multicenter studies reveal rates ranging from 20% to 64% use, lasting about 5 to 6 days. The practice of using artificial methods to provide respiratory care is considered a revolution in the care of critically ill patients, reducing their morbidity and mortality. On the other hand, it is widely known that these tools bring with it a myriad of possible complications, such as Health Care-Associated Pneumonia, upper and lower airway injuries, risks related to sedation, and cardiovascular instability. Therefore, it is indispensable to interrupt the MV as soon as possible. When is spent a lot of time recognizing that the MV is no longer essential, is increased the risks and costs (up to $ 2,000 a day), and is failed the good medical practice. Currently, the duration of weaning consumes about 40% of the total MV time. This depends on many factors, such as fluid balance, positive end expiratory pressure (PEEP), sedation, pulmonary hypertension and diaphragm function, among others. Studies have shown that the implementation of a weaning protocol reduces its duration and, consequently, ventilation in children. There are numerous known weaning techniques, however, the most commonly used approach is the progressive reduction of ventilatory support already in use, maintaining the same modes and reducing the parameters. Some professionals choose synchronized intermittent mandatory ventilation (SIMV), reducing respiratory rate, with or without Supplementary Pressure (PS) association. Others prefer to perform daily extubation readiness tests (ERT) or to switch spontaneous breathing methods with full-support ventilation for respiratory muscle training, this practice is more common in adult ICUs. Exhorted by recommendations for mechanical ventilation of critically ill children at the 2017 pediatric mechanical ventilation consensus conference (PEMVECC), who concluded with strong agreement that there is insufficient data to recommend the method for weaning the investigators decided to study the assertive. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04023643
Study type Interventional
Source São Paulo State University
Contact
Status Active, not recruiting
Phase N/A
Start date October 1, 2020
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT04107467 - Mechanical Ventilation Epidemiology in Argentina.
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Recruiting NCT05459116 - Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation N/A
Completed NCT01170156 - Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre N/A
Recruiting NCT05141396 - Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH) N/A
Completed NCT04512677 - Ventilatory Weaning Guided by a New Index N/A
Withdrawn NCT00536445 - Use of NAVA in Intubated Preterm Phase 1/Phase 2
Completed NCT00097630 - ABC Trial: Awakening and Breathing Controlled N/A
Recruiting NCT04602182 - Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation N/A
Recruiting NCT06120660 - Musical Intervention on Stress Effects in Critically Ill Patients N/A
Recruiting NCT03684291 - Hemodynamic Effects of Ventilation Modes
Recruiting NCT06195475 - Association Between Tidal Volume and Mortality in Pressure Support in Adults Under Invasive Mechanical Ventilation
Completed NCT05254691 - WOB and Paediatric Mechanical Ventilation N/A
Terminated NCT00790725 - Proportional Assist Ventilation vs Pressure Support Ventilation N/A
Completed NCT00638339 - Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)
Not yet recruiting NCT03255356 - Ventilation in Cardiac Surgery N/A
Completed NCT01155648 - Pressure Support During Chest Wall Compression N/A
Completed NCT00583037 - 24-Hour NAVA Ventilation in Acute Respiratory Failure N/A