Mechanical Ventilation ComplicationNCT05805475
Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children
A study testing Endotracheal suctioning with expiratory pause and Endotracheal suctioning without expiratory pause in people with Mechanical Ventilation Complication and Pediatric Respiratory Diseases, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Mechanical Ventilation Complication, Pediatric Respiratory Diseases
- What is being tested?
- Endotracheal suctioning with expiratory pause and Endotracheal suctioning without expiratory pause
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2023to 30 Jun 2024
- 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 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children at invasive mechanical ventilation for more than 24 hours;
- Under the effect of neuromuscular blocker (level of sedation assessed using the Comfort B Scale with a score <10 and without a cough reflex);
- Endotracheal suctioning in a period > 2h before the application of the technique.
Who cannot join
- Patients with undrained pneumothorax or hemothorax, or presence of subcutaneous emphysema;
- Hemodynamic instability (hypotension refractory to treatment)
- Need of frequent endotracheal suctioning
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Effects of Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children Submitted to Invasive Mechanical Ventilation: a Randomized Crossover Clinical Trial
The purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation.
Read the detailed description
After being informed about the study and potential risks, all parents or guardians giving written informed consent will be evaluate for study entry. Children in invasive mechanical ventilation who meet eligibility criteria will be submitted of two techniques of tracheal suctioning (with and without expiratory pause maneuver), randomized in a crossover trial in a 1:1 ratio, for determine the first technique to be applied.
Clinical data will be collected (sex, age, presence of previous disease, diagnosis of hospitalization), as well as the ventilatory parameters (ventilation mode, peak inspiratory pressure, positive end-expiratory pressure, tidal volume, respiratory frequency, fraction of inspired oxygen).
The protocol consists of an initial conventional tracheal suctioning with a negative pressure of 40mmHg for all the participants. After two (2) hours the first technique will be applied and an interval of another two hours for the application of the second technique. Respiratory mechanics and hemodynamic parameters will be evaluate before and after 30 minutes of each tracheal suctioning techniques.
In case of clinical alterations that may aggravate the patients condition during the protocol (oxygen saturation < 85%, heart rate > 190bpm and/or decrease 20% of mean arterial blood pressure), the technique will be interrupted immediately and the patient will be evaluated.
- Being tested
- Endotracheal suctioning with expiratory pause, Endotracheal suctioning without expiratory pause
- Keywords
- Pediatric Critical Care, Respiratory Mechanics, Tracheal Suctioning, Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal suctioning with expiratory pauseOther
Perform closed endotracheal suctioning with an expiratory pause of 5 seconds
Endotracheal suctioning without expiratory pauseOther
Perform closed endotracheal suctioning without expiratory pause
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal suctioning without expiratory pause | Active comparator | Conventional endotracheal suctioning in closed suction system Receives: Other: Endotracheal suctioning without expiratory pause |
| Endotracheal suctioning with expiratory pause | Experimental | Endotracheal suctioning in closed suction system associated with expiratory pause maneuver Receives: Other: Endotracheal suctioning with expiratory pause |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight of endotracheal suctioning
Weight of endotracheal suctioning in milligrams
Measured: Immediately after suctioning
Secondary outcomes (6)
Peak inspiratory pressure
Peak inspiratory pressure in centimeters of water (cmH2O)
Measured: Baseline and 30 minutes
Plateau pressure
Plateau pressure in centimeters of water (cmH2O)
Measured: Baseline and 30 minutes
Tidal volume
Tidal volume in milliliters (ml)
Measured: Baseline and 30 minutes
Dynamic compliance
Dynamic compliance in milliliters per kilograms per centimeters of water (mL/kg/cmH2O)
Measured: Baseline and 30 minutes
Airway resistance
Inspiratory and expiratory resistance in centimeters of water per liter (cmH2O/L)
Measured: Baseline and 30 minutes
Auto-positive end-expiratory pressure (auto-PEEP)
Auto-PEEP in centimeters of water (cmH2O)
Measured: Baseline and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Apr 2023
- Primary completion1 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruna Ziegler, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805475
- Sponsor's protocol ID
- 2022-0072
- Status last verified
- Jul 2024
- First submitted
- 14 Mar 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children Submitted to Invasive Mechanical Ventilation: a Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT05805475
- Acronym / sponsor ID
- 2022-0072
- Keywords
- Pediatric Critical Care, Respiratory Mechanics, Tracheal Suctioning, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 10 Apr 2023 (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.
The purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation.
Detailed description
After being informed about the study and potential risks, all parents or guardians giving written informed consent will be evaluate for study entry. Children in invasive mechanical ventilation who meet eligibility criteria will be submitted of two techniques of tracheal suctioning (with and without expiratory pause maneuver), randomized in a crossover trial in a 1:1 ratio, for determine the first technique to be applied.
Clinical data will be collected (sex, age, presence of previous disease, diagnosis of hospitalization), as well as the ventilatory parameters (ventilation mode, peak inspiratory pressure, positive end-expiratory pressure, tidal volume, respiratory frequency, fraction of inspired oxygen).
The protocol consists of an initial conventional tracheal suctioning with a negative pressure of 40mmHg for all the participants. After two (2) hours the first technique will be applied and an interval of another two hours for the application of the second technique. Respiratory mechanics and hemodynamic parameters will be evaluate before and after 30 minutes of each tracheal suctioning techniques.
In case of clinical alterations that may aggravate the patients condition during the protocol (oxygen saturation < 85%, heart rate > 190bpm and/or decrease 20% of mean arterial blood pressure), the technique will be interrupted immediately and the patient will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal suctioning without expiratory pause | Active comparator | Other: Endotracheal suctioning without expiratory pauseConventional endotracheal suctioning in closed suction system |
| Endotracheal suctioning with expiratory pause | Experimental | Other: Endotracheal suctioning with expiratory pauseEndotracheal suctioning in closed suction system associated with expiratory pause maneuver |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children at invasive mechanical ventilation for more than 24 hours;
- Under the effect of neuromuscular blocker (level of sedation assessed using the Comfort B Scale with a score <10 and without a cough reflex);
- Endotracheal suctioning in a period > 2h before the application of the technique.
Key exclusion criteria (3 listed)
- Patients with undrained pneumothorax or hemothorax, or presence of subcutaneous emphysema;
- Hemodynamic instability (hypotension refractory to treatment)
- Need of frequent endotracheal suctioning
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 |
|---|---|---|
| Endotracheal suctioning with expiratory pausePerform closed endotracheal suctioning with an expiratory pause of 5 seconds | Other | Endotracheal suctioning with expiratory pause |
| Endotracheal suctioning without expiratory pausePerform closed endotracheal suctioning without expiratory pause | Other | Endotracheal suctioning without expiratory pause |
Primary outcome
Weight of endotracheal suctioning
Time frame: Immediately after suctioning
Weight of endotracheal suctioning in milligrams
6 secondary outcomes
Peak inspiratory pressure
Time frame: Baseline and 30 minutes
Plateau pressure
Time frame: Baseline and 30 minutes
Tidal volume
Time frame: Baseline and 30 minutes
Dynamic compliance
Time frame: Baseline and 30 minutes
Airway resistance
Time frame: Baseline and 30 minutes
Auto-positive end-expiratory pressure (auto-PEEP)
Time frame: Baseline and 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Bruna Ziegler principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal suctioning with expiratory pause and Endotracheal suctioning without expiratory pause in people with Mechanical Ventilation Complication and Pediatric Respiratory Diseases, run by Hospital de Clinicas de Porto Alegre 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight of endotracheal suctioning (time frame: Immediately after suctioning). 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 23 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.