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出境医 / 临床实验 / Pediatric Ventilation Weaning (PROVENTUS)

Pediatric Ventilation Weaning (PROVENTUS)

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Respiration, Artificial Ventilator Weaning Other: Ventilation Weaning Not Applicable

Detailed 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pragmatic And Randomized Pediatric Ventilation Weaning Trial
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: CPAP + PS
Weaning from mechanical ventilation using CPAP + PS
Other: Ventilation Weaning
Use of different weaning strategies

Active Comparator: SIMV + PS
Weaning from mechanical ventilation using SIMV+PS
Other: Ventilation Weaning
Use of different weaning strategies

Outcome Measures
Primary Outcome Measures :
  1. Rate of Ventilator-free days [ Time Frame: 4 days ]
    Rate of free days of mechanical ventilation during ICU admission in children who were intubated. Assessed by the data collection form filled daily by the collaborators.

  2. Rate of Weaning duration [ Time Frame: 12 hours ]
    Amount of hours spent in ventilator weaning. Assessed by the data collection form filled daily by the collaborators.


Secondary Outcome Measures :
  1. Rate of PICU length of Stay [ Time Frame: 10 days ]
    Amount of days spent in PICU. Assessed by the data collection form filled daily by the collaborators.

  2. Incidence of Complications associated with mechanical ventilation [ Time Frame: 10 days ]
    Incidence of Health Care associated Pneumonia; tracheitis; barotrauma; extubation laryngitis. Diagnosed according to the protocols in force at the institution and Assessed by the data collection form filled daily by the collaborators.

  3. Rates of spontaneous breathing test failure [ Time Frame: 6 days ]
    Rates of spontaneous breathing test failure. Assessed by the data collection form filled daily by the collaborators.


Eligibility Criteria
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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children who underwent mechanical ventilation for at least 24 hours in one of the participant PICUs

Exclusion Criteria:

  • Children dependent on mechanical ventilation and / or chronically supplemental oxygen;
  • Children with do not resuscitation order (DNR)
  • Children with neurological and neuromuscular disorders that may interfere with MV;
  • Children with chronic lung diseases (such as cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, with the exception of asthma);
  • Children transferred from another PICU not included in the trial and whose weaning has already begun;
  • Children whose cannulae have air leakage higher of 25% of inspiratory flow, without indication for cannula replacement.
Contacts and Locations

Contacts
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Contact: Murilo Lourenção, MD +5511947100733 murilo.ll@hotmail.com

Locations
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Brazil
Hospital das Clínicas de Marília - Unidade II Recruiting
Marília, SP, Brazil, 17500030
Contact: Fernanda Augusto, MD PhD         
Hospital Municipal Vila Santa Catarina Recruiting
São Paulo, Brazil, 04378-500
Contact: Albert Bousso, PhD, MSC, MD         
Principal Investigator: Tadeu Renattini         
Hospital Municipal Dr. Moysés Deutsch Recruiting
São Paulo, Brazil, 04948-970
Contact: Fernanda Elias, MD         
Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, Brazil, 05403-000
Contact: Arthur Delgado, PhD, MSC, MD         
Hospital Universitário da Universidade de São Paulo Recruiting
São Paulo, Brazil, 05508-000
Contact: Andrea Ventura, MSC, MD         
Sponsors and Collaborators
São Paulo State University
Andréa Maria Cordeiro Ventura
Investigators
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Principal Investigator: Murilo Lourenção, MD HU-USP
Study Director: Andrea Ventura, MSC, MD HU-USP
Tracking Information
First Submitted Date  ICMJE July 12, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Rate of Ventilator-free days [ Time Frame: 4 days ]
    Rate of free days of mechanical ventilation during ICU admission in children who were intubated. Assessed by the data collection form filled daily by the collaborators.
  • Rate of Weaning duration [ Time Frame: 12 hours ]
    Amount of hours spent in ventilator weaning. Assessed by the data collection form filled daily by the collaborators.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Rate of PICU length of Stay [ Time Frame: 10 days ]
    Amount of days spent in PICU. Assessed by the data collection form filled daily by the collaborators.
  • Incidence of Complications associated with mechanical ventilation [ Time Frame: 10 days ]
    Incidence of Health Care associated Pneumonia; tracheitis; barotrauma; extubation laryngitis. Diagnosed according to the protocols in force at the institution and Assessed by the data collection form filled daily by the collaborators.
  • Rates of spontaneous breathing test failure [ Time Frame: 6 days ]
    Rates of spontaneous breathing test failure. Assessed by the data collection form filled daily by the collaborators.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Ventilation Weaning
Official Title  ICMJE Pragmatic And Randomized Pediatric Ventilation Weaning Trial
Brief 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.
Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Respiration, Artificial
  • Ventilator Weaning
Intervention  ICMJE Other: Ventilation Weaning
Use of different weaning strategies
Study Arms  ICMJE
  • Experimental: CPAP + PS
    Weaning from mechanical ventilation using CPAP + PS
    Intervention: Other: Ventilation Weaning
  • Active Comparator: SIMV + PS
    Weaning from mechanical ventilation using SIMV+PS
    Intervention: Other: Ventilation Weaning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children who underwent mechanical ventilation for at least 24 hours in one of the participant PICUs

Exclusion Criteria:

  • Children dependent on mechanical ventilation and / or chronically supplemental oxygen;
  • Children with do not resuscitation order (DNR)
  • Children with neurological and neuromuscular disorders that may interfere with MV;
  • Children with chronic lung diseases (such as cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, with the exception of asthma);
  • Children transferred from another PICU not included in the trial and whose weaning has already begun;
  • Children whose cannulae have air leakage higher of 25% of inspiratory flow, without indication for cannula replacement.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Murilo Lourenção, MD +5511947100733 murilo.ll@hotmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023643
Other Study ID Numbers  ICMJE 90326618.7.1001.0076
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Murilo Lourenção, São Paulo State University
Study Sponsor  ICMJE São Paulo State University
Collaborators  ICMJE Andréa Maria Cordeiro Ventura
Investigators  ICMJE
Principal Investigator: Murilo Lourenção, MD HU-USP
Study Director: Andrea Ventura, MSC, MD HU-USP
PRS Account São Paulo State University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP