Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics Randomized, Crossover Clinical Study (expirapause)
Primary Purpose
Respiratory Insufficiency in Children
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
with pause- without pause
without pause-with pause
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Insufficiency in Children focused on measuring Respiratory Insufficiency, respiratory artificial
Eligibility Criteria
Inclusion Criteria:
- Patients aged 0 to 5 years and 11 months who have been on invasive mechanical ventilation for more than 24 hours through an orotracheal cannula or tracheostomy will be included in the study.
Exclusion Criteria:
- Patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study will be excluded from the study.
Sites / Locations
- Albert Eisntein HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
with pause- without pause
without pause - with pause
Arm Description
Start with an expiratory pause during aspiration and after 6hours the aspiration is performed without an expiratory pause
Start without an expiratory pause during aspiration and after 6hours the aspiration is performed with an expiratory pause
Outcomes
Primary Outcome Measures
secretion mass
The secretion will be weighed on a scale graduated in milligrams.
Secondary Outcome Measures
tidal volume
tidal volume checked on the mechanical ventilator graduated in ml
Full Information
NCT ID
NCT05418530
First Posted
March 3, 2022
Last Updated
June 9, 2022
Sponsor
Hospital Israelita Albert Einstein
1. Study Identification
Unique Protocol Identification Number
NCT05418530
Brief Title
Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics Randomized, Crossover Clinical Study
Acronym
expirapause
Official Title
Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics: A Randomized, Crossover Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Introduction: Patients on mechanical ventilation suffer alterations in the viscoelastic characteristics of the mucus due to changes in the humidity and temperature of the inhaled air and in the respiratory volumes and flows. The literature has pointed out the use of mechanical ventilators as a tool for mobilizing secretions and closed-system aspiration associated with expiratory pause has been shown to be effective in mobilizing secretions. Objectives: To assess whether there is a difference in the mass of aspirated secretion with the application of the expiratory pause during aspiration. Methods: A crossover, randomized study. Applied to children aged 0 to 5 years and 11 months who are intubated for 24 hours with orotracheal tubes or tracheostomy. There will be an exclusion of patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study. The technique will be during aspiration in the tube with where to apply or not the expiratory pause on the mechanical ventilator. This secretion will be weighed so that there is fidelity in the results.
Detailed Description
A prospective, crossover, randomized clinical study will be carried out in the Pediatric ICU of Hospital Israelite Albert Einstein.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency in Children
Keywords
Respiratory Insufficiency, respiratory artificial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients who meet the inclusion criteria and after signing the informed consent by the guardian will be randomized to closed system aspiration with an expiratory pause and closed system aspiration without an expiratory pause. Randomization will be performed by blocks of sealed envelopes, allocating the patient to a first technique to be performed and, after 6 hours, to another technique. All patients will perform both forms of aspiration and will be aspirated 2 hours before the start of each technique to match the groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
with pause- without pause
Arm Type
Active Comparator
Arm Description
Start with an expiratory pause during aspiration and after 6hours the aspiration is performed without an expiratory pause
Arm Title
without pause - with pause
Arm Type
Active Comparator
Arm Description
Start without an expiratory pause during aspiration and after 6hours the aspiration is performed with an expiratory pause
Intervention Type
Other
Intervention Name(s)
with pause- without pause
Intervention Description
start with pause expiration
Intervention Type
Other
Intervention Name(s)
without pause-with pause
Intervention Description
start without pause expiration
Primary Outcome Measure Information:
Title
secretion mass
Description
The secretion will be weighed on a scale graduated in milligrams.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
tidal volume
Description
tidal volume checked on the mechanical ventilator graduated in ml
Time Frame
6 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 0 to 5 years and 11 months who have been on invasive mechanical ventilation for more than 24 hours through an orotracheal cannula or tracheostomy will be included in the study.
Exclusion Criteria:
Patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study will be excluded from the study.
Facility Information:
Facility Name
Albert Eisntein Hospital
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena S Nascimento
Phone
5511984520061
Email
milena.nascimento@einstein.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
the results of the study can be requested by the person responsible for the patient and these will be sent by emial
Learn more about this trial
Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics Randomized, Crossover Clinical Study
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