Mechanical VentilationAsynchronyNCT03138148
Evaluation of the Patient-ventilator Asynchrony During Mechanical Ventilation for Pediatric Acute Respiratory Failure
An observational study of Mechanical Ventilation, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The synchronization between the patient and the ventilator is an essential objective during mechanical ventilation (MV). Maintaining the patient's respiratory activity during MV reduces ventilation pressures, improves oxygenation, and decreases sedation. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Routine mechanical ventilation
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 26 May 2010to 6 Jan 2017
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients under mechanical ventilation for acute respiratory failure
Who may be able to join
- Mechanical ventilation planned for more than 24h according to the physician in charge;
- Presence of a spontaneous respiratory activity (defined by the presence of respiratory cycles activated by the patient);
- Parental consent obtained with the parents or with the legal representative.
Who cannot join
- pathologies for which a long and difficult weaning of the mechanical ventilation is expected: chronic respiratory failure with history of ventilation superior to one month, severe neurological or muscular pathology;
- Patients with a tracheotomy;
- Patients receiving a treatment by curare;
- Contraindication of recording of the diaphragmatic activity by oesophageal way, in particular recent oesophageal surgery, oesophageal stenosis, suspicion of diaphragmatic paralysis, severe coagulation disorder;
- Patients to whom a death seems imminent;
- Patients for whom a limitation of the care was considered.
Trial locations and contacts
1 site in 1 country.
About this study
The synchronization between the patient and the ventilator is an essential objective during mechanical ventilation (MV). Maintaining the patient's respiratory activity during MV reduces ventilation pressures, improves oxygenation, and decreases sedation. In order to do this, the inspiratory or expiratory effort of the patient must be detected by the respirator' sensor systems, so that the assistance delivered by the respirator is coordinated with the patient's respiratory cycles. The usual systems do not actually detect the beginning of the effort but its result: variation in flow rate or pressure at the respirator circuit, which depends on the patient's respiratory mechanics and sensitivity of the sensor. This detection is currently imperfect, which generates asynchrony between the patient's needs and the assistance of the respirator. The asynchrony comprises the periods of delay between the beginning of the inspiration (or expiration) and the response of the respirator, but also of the unsuitable cycles: inspiratory efforts of the patient not detected by the respirator, or inversely triggering assistance in the absence of inspiration by the patient (self-initiation), or delivery of 2 cycles of assistance for a single inspiration (double triggering).
Asynchrony is a risk factor for prolonged mechanical ventilation in adults. Adult studies have shown that patient-ventilator asynchrony is common during MV, and is associated with prolonged MV duration. An association with length of stay in intensive care and in hospital was also observed. In children, patient-ventilator synchronization is more difficult to achieve than in adults due to a higher respiratory rate and smaller current volumes. The impact of patient-ventilator asynchrony on evolution has not been studied in pediatrics.
Read more
Patient-ventilator synchronization could be improved by the development of new ventilatory modes. The new NAVA (neurally adjusted ventilatory assist) ventilation mode detects the patient's breathing efforts earlier by monitoring the electrical activity of the diaphragm through the esophagus. This new mode seems to improve synchronization in children. NAVA ventilation may therefore be a step forward, but its clinical benefits remain to be seen.
The objective of this study is to evaluate the impact of patient-ventilator asynchrony on the duration of mechanical ventilation in children with acute respiratory failure.
- Conditions
- Mechanical Ventilation
- Being tested
- Routine mechanical ventilation
- Keywords
- intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine mechanical ventilationOther
Routine mechanical ventilation in PICU amid children with acute respiratory failure
| Study group | Role | What they receive |
|---|---|---|
| Severe patient-ventilator asynchrony | Patients in whom the total percentage of time spent in asynchrony is superior to the entire cohort's 75th percentile Receives: Other: Routine mechanical ventilation | |
| less severe patient-ventilator asynchrony | Patients in whom the total percentage of time spent in asynchrony is inferior to the entire cohort's 75th percentile Receives: Other: Routine mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ventilator free days
Difference in ventilator free days at Day 28th between the two patient groups (high versus moderate asynchrony)
Measured: 28 days
Secondary outcomes (3)
The impact of asynchrony on Comfort scale
Comfort Scale between the two patient groups (high versus moderate asynchrony)
Measured: at inclusion
Intensive care unit length of stay
between the two patient groups (high versus moderate asynchrony)
Measured: 28 days
Mortality in pediatric intensive care unit
between the two patient groups (high versus moderate asynchrony)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start26 May 2010
- Primary completion17 Oct 2012
- Study completion6 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Guillaume Emeriaud, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138148
- Sponsor's protocol ID
- CHUSJ-3113
- Acronym
- Asynchrony
- Status last verified
- May 2017
- First submitted
- 27 Apr 2017
- Last updated
- 5 May 2017
- 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 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Patient-ventilator Asynchrony During Mechanical Ventilation for Pediatric Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT03138148
- Acronym / sponsor ID
- Asynchrony / CHUSJ-3113
- Conditions
- Mechanical Ventilation
- Keywords
- intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 26 May 2010 (actual)
- Primary completion
- 17 Oct 2012 (actual)
- Study completion
- 6 Jan 2017 (actual)
- First posted
- 3 May 2017 (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 synchronization between the patient and the ventilator is an essential objective during mechanical ventilation (MV). Maintaining the patient's respiratory activity during MV reduces ventilation pressures, improves oxygenation, and decreases sedation. In order to do this, the inspiratory or expiratory effort of the patient must be detected by the respirator' sensor systems, so that the assistance delivered by the respirator is coordinated with the patient's respiratory cycles. The usual systems do not actually detect the beginning of the effort but its result: variation in flow rate or pressure at the respirator circuit, which depends on the patient's respiratory mechanics and sensitivity of the sensor. This detection is currently imperfect, which generates asynchrony between the patient's needs and the assistance of the respirator. The asynchrony comprises the periods of delay between the beginning of the inspiration (or expiration) and the response of the respirator, but also of the unsuitable cycles: inspiratory efforts of the patient not detected by the respirator, or inversely triggering assistance in the absence of inspiration by the patient (self-initiation), or delivery of 2 cycles of assistance for a single inspiration (double triggering).
Asynchrony is a risk factor for prolonged mechanical ventilation in adults. Adult studies have shown that patient-ventilator asynchrony is common during MV, and is associated with prolonged MV duration. An association with length of stay in intensive care and in hospital was also observed. In children, patient-ventilator synchronization is more difficult to achieve than in adults due to a higher respiratory rate and smaller current volumes. The impact of patient-ventilator asynchrony on evolution has not been studied in pediatrics.
Patient-ventilator synchronization could be improved by the development of new ventilatory modes. The new NAVA (neurally adjusted ventilatory assist) ventilation mode detects the patient's breathing efforts earlier by monitoring the electrical activity of the diaphragm through the esophagus. This new mode seems to improve synchronization in children. NAVA ventilation may therefore be a step forward, but its clinical benefits remain to be seen.
The objective of this study is to evaluate the impact of patient-ventilator asynchrony on the duration of mechanical ventilation in children with acute respiratory failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe patient-ventilator asynchrony | – | Other: Routine mechanical ventilationPatients in whom the total percentage of time spent in asynchrony is superior to the entire cohort's 75th percentile |
| less severe patient-ventilator asynchrony | – | Other: Routine mechanical ventilationPatients in whom the total percentage of time spent in asynchrony is inferior to the entire cohort's 75th percentile |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients under mechanical ventilation for acute respiratory failure
Key inclusion criteria (3 listed)
- Mechanical ventilation planned for more than 24h according to the physician in charge;
- Presence of a spontaneous respiratory activity (defined by the presence of respiratory cycles activated by the patient);
- Parental consent obtained with the parents or with the legal representative.
Key exclusion criteria (6 listed)
- pathologies for which a long and difficult weaning of the mechanical ventilation is expected: chronic respiratory failure with history of ventilation superior to one month, severe neurological or muscular pathology;
- Patients with a tracheotomy;
- Patients receiving a treatment by curare;
- Contraindication of recording of the diaphragmatic activity by oesophageal way, in particular recent oesophageal surgery, oesophageal stenosis, suspicion of diaphragmatic paralysis, severe coagulation disorder;
- Patients to whom a death seems imminent;
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 |
|---|---|---|
| Routine mechanical ventilationRoutine mechanical ventilation in PICU amid children with acute respiratory failure | Other | Severe patient-ventilator asynchrony, less severe patient-ventilator asynchrony |
Primary outcome
Difference in ventilator free days
Time frame: 28 days
Difference in ventilator free days at Day 28th between the two patient groups (high versus moderate asynchrony)
3 secondary outcomes
The impact of asynchrony on Comfort scale
Time frame: at inclusion
Intensive care unit length of stay
Time frame: 28 days
Mortality in pediatric intensive care unit
Time frame: 28 days
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 5 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by St. Justine's Hospital at 1 site in Canada.
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 6 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 5 May 2017. 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 Canada. 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?
Difference in ventilator free days (time frame: 28 days). 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 5 May 2017.