Respiratory Insufficiency in ChildrenexpirapauseNCT05418530
Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics Randomized, Crossover Clinical Study
A study testing with pause- without pause and without pause-with pause in people with Respiratory Insufficiency in Children, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Respiratory Insufficiency in Children
- What is being tested?
- with pause- without pause and without pause-with pause
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Apr 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Albert Eisntein Hospital
São Paulo
Milena S Nascimento, 5511984520061, milena.nascimento@einstein.br
About this study
Official title: Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics: A Randomized, Crossover Clinical Study
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.
Read the detailed description
A prospective, crossover, randomized clinical study will be carried out in the Pediatric ICU of Hospital Israelite Albert Einstein.
- Conditions
- Respiratory Insufficiency in Children
- Being tested
- with pause- without pause, without pause-with pause
- Keywords
- Respiratory Insufficiency, respiratory artificial
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with pause- without pauseOther
start with pause expiration
without pause-with pauseOther
start without pause expiration
| Study group | Role | What they receive |
|---|---|---|
| with pause- without pause | Active comparator | Start with an expiratory pause during aspiration and after 6hours the aspiration is performed without an expiratory pause Receives: Other: with pause- without pause |
| without pause - with pause | Active comparator | Start without an expiratory pause during aspiration and after 6hours the aspiration is performed with an expiratory pause Receives: Other: without pause-with pause |
What is being measured
The primary outcome is the main question the study is designed to answer.
secretion mass
The secretion will be weighed on a scale graduated in milligrams.
Measured: 6 hours
Secondary outcomes (1)
tidal volume
tidal volume checked on the mechanical ventilator graduated in ml
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start22 Apr 2022
- Primary completion22 Apr 2022
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Insufficiency in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418530
- Sponsor's protocol ID
- expiratory pause_2022
- Acronym
- expirapause
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the results of the study can be requested by the person responsible for the patient and these will be sent by emial
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics: A Randomized, Crossover Clinical Study
- ClinicalTrials.gov ID
- NCT05418530
- Acronym / sponsor ID
- expirapause / expiratory pause_2022
- Conditions
- Respiratory Insufficiency in Children
- Keywords
- Respiratory Insufficiency, respiratory artificial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| with pause- without pause | Active comparator | Other: with pause- without pauseStart with an expiratory pause during aspiration and after 6hours the aspiration is performed without an expiratory pause |
| without pause - with pause | Active comparator | Other: without pause-with pauseStart without an expiratory pause during aspiration and after 6hours the aspiration is performed with an expiratory pause |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with pause- without pausestart with pause expiration | Other | with pause- without pause |
| without pause-with pausestart without pause expiration | Other | without pause - with pause |
Primary outcome
secretion mass
Time frame: 6 hours
The secretion will be weighed on a scale graduated in milligrams.
1 secondary outcome
tidal volume
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: Undecided. the results of the study can be requested by the person responsible for the patient and these will be sent by emial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with pause- without pause and without pause-with pause in people with Respiratory Insufficiency in Children, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
secretion mass (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.