Mechanical VentilationAPPLENCT02762279
Assessment of Esophageal Pressure Reliability to Estimate Pleural Pressure in Critically Ill Children
A study testing esophageal and pleural pressure measurement in people with Mechanical Ventilation, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Background During ventilatory assistance, optimization of settings is critical to allow a personalized support and avoid over- or under-assistance. But little data are available in clinical practice to guide the adjustment of the support. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- esophageal and pleural pressure measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2016to 1 Oct 2017
- 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 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children <18 years old, hospitalized in the pediatric intensive care unit;
- Requiring invasive ventilation for more than 4 hours according to the prescription of the attending physician;
- With at least one chest tube.
Who cannot join
- Contraindications to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical or nasopharyngeal regions, severe coagulation disorder);
- Hemodynamic instability, as defined by the treating team, and the absence of recent (<4 hours) increase in the flow of dopamine, epinephrine, norepinephrine, or dobutamine;
- Respiratory instability defined as a severe respiratory failure requiring FiO2 > 60%, or PaCO2 > 80 mmHg on blood gas in the last hour;
- Persistent pleural effusion or pneumothorax despite the chest-tube;
- Bronchopleural fistula;
- Recent (<12 hours) thoracic hemorrhage;
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- Delayed sternal closure at the time of study;
- Significant pericardial effusion;
- Absence of parental or tutor consent;
- Patient for whom a limitation of life support treatments is discussed or decided.
Trial locations and contacts
1 site in 1 country.
About this study
Background During ventilatory assistance, optimization of settings is critical to allow a personalized support and avoid over- or under-assistance. But little data are available in clinical practice to guide the adjustment of the support. In adults, esophageal pressure (PES) has been shown to be a reliable surrogate of pleural pressure (PPL) and clinical studies suggest that PES may be useful to guide the management of mechanical ventilation. In children, the PES measurement could have similar potential benefits, but beforehand the reliability of PES to estimate PPL needs to be assessed.
Objective The primary objective of this study is to validate the reliability of PES directly monitored using a miniature catheter tip pressure transducer (Gaeltec® system) to estimate PPL, when compared to a gold standard, i.e the direct PPL measurement in situ.
Read more
Method This is a prospective single center study. Children <18 years old, hospitalized in the pediatric intensive care unit, requiring invasive ventilation and with at least one chest tube will be included.
Protocol A pressure transducer will be connected to the existing chest-tube and PES (measured by Gaeltec® and feeding tube), PPL, PAW, respiratory volume and flow will be simultaneously recorded.
Expected results We expect that the PES-based methods will provide an accurate estimation of PPL. Once this tool validated, PES could be helpful to optimize mechanical ventilation in children, and further interventional trials would be warranted to evaluate if its use could allow a reduction of the ventilation support duration.
- Conditions
- Mechanical Ventilation
- Being tested
- esophageal and pleural pressure measurement
- Keywords
- Mechanical ventilation, Children, Esophageal Pressure, Pleural Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophageal and pleural pressure measurementOther
Esophageal pressure will be monitored by a dedicated catheter and pleural pressure will be measured into the chest tube already in place
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | 1. Patient baseline characteristics will be collected.
2. Specific nasogastric tube installation: a specific nasogastric tube equipped with pressure transducers (Gaeltec® probe) will be installed.
3. Connection of a pressure transducer to the existing chest-tube.
4. Simultaneous recordings of PES (Gaeltec®), PPL, PAW, respiratory volume and flow (5 minutes).
5. Removal of the Gaeltec® probe, and repositioning of the pre-existing nasogastric tube in the esophagus for PES measurement.
6. Simultaneous recordings of PES (feeding tube), PPL, PAW, respiratory volume and flow (5 minutes).
7. Repositioning of the nasogastric tube in the stomach, and disconnection of the different recording equipment. Receives: Other: esophageal and pleural pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-expiratory esophageal
End-expiratory PES and PL, calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts;
Measured: Up to 2 hours from the beginning of the study
Pleural pressure
PPL, directly measured in the existing chest tubes, and calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts.
Measured: Up to 2 hours from the beginning of the study
transpulmonary pressures
Measured: Up to 2 hours from the beginning of the study
Secondary outcomes (1)
The Elastance-derived end-inspiratory transpulmonary pressure
The Elastance-derived end-inspiratory transpulmonary pressure, calculated as: PAW at end-inspiration x EL/ERS (EI and ERS being the respective elastances of the lung and the respiratory system, estimated on the esophageal and airway Pressure-Volume curves);
Measured: Up to 2 hours from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start28 Jun 2016
- Primary completion1 Oct 2017
- Study completion1 Oct 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02762279
- Sponsor's protocol ID
- CHUSJ 2016-1238
- Acronym
- APPLE
- Status last verified
- Aug 2018
- First submitted
- 28 Apr 2016
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Esophageal Pressure Reliability to Estimate Pleural Pressure in Critically Ill Children
- ClinicalTrials.gov ID
- NCT02762279
- Acronym / sponsor ID
- APPLE / CHUSJ 2016-1238
- Conditions
- Mechanical Ventilation
- Keywords
- Mechanical ventilation, Children, Esophageal Pressure, Pleural Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 4 May 2016 (estimated)
- 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.
Background During ventilatory assistance, optimization of settings is critical to allow a personalized support and avoid over- or under-assistance. But little data are available in clinical practice to guide the adjustment of the support. In adults, esophageal pressure (PES) has been shown to be a reliable surrogate of pleural pressure (PPL) and clinical studies suggest that PES may be useful to guide the management of mechanical ventilation. In children, the PES measurement could have similar potential benefits, but beforehand the reliability of PES to estimate PPL needs to be assessed.
Objective The primary objective of this study is to validate the reliability of PES directly monitored using a miniature catheter tip pressure transducer (Gaeltec® system) to estimate PPL, when compared to a gold standard, i.e the direct PPL measurement in situ.
Method This is a prospective single center study. Children <18 years old, hospitalized in the pediatric intensive care unit, requiring invasive ventilation and with at least one chest tube will be included.
Protocol A pressure transducer will be connected to the existing chest-tube and PES (measured by Gaeltec® and feeding tube), PPL, PAW, respiratory volume and flow will be simultaneously recorded.
Expected results We expect that the PES-based methods will provide an accurate estimation of PPL. Once this tool validated, PES could be helpful to optimize mechanical ventilation in children, and further interventional trials would be warranted to evaluate if its use could allow a reduction of the ventilation support duration.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: esophageal and pleural pressure measurement1. Patient baseline characteristics will be collected. 2. Specific nasogastric tube installation: a specific nasogastric tube equipped with pressure transducers (Gaeltec® probe) will be installed. 3. Connection of a pressure transducer to the existing chest-tube. 4. Simultaneous recordings of PES (Gaeltec®), PPL, PAW, respiratory volume and flow (5 minutes). 5. Removal of the Gaeltec® probe, and repositioning of the pre-existing nasogastric tube in the esophagus for PES measurement. 6. Simultaneous recordings of PES (feeding tube), PPL, PAW, respiratory volume and flow (5 minutes). 7. Repositioning of the nasogastric tube in the stomach, and disconnection of the different recording equipment. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children <18 years old, hospitalized in the pediatric intensive care unit;
- Requiring invasive ventilation for more than 4 hours according to the prescription of the attending physician;
- With at least one chest tube.
Key exclusion criteria (10 listed)
- Contraindications to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical or nasopharyngeal regions, severe coagulation disorder);
- Hemodynamic instability, as defined by the treating team, and the absence of recent (<4 hours) increase in the flow of dopamine, epinephrine, norepinephrine, or dobutamine;
- Respiratory instability defined as a severe respiratory failure requiring FiO2 > 60%, or PaCO2 > 80 mmHg on blood gas in the last hour;
- Persistent pleural effusion or pneumothorax despite the chest-tube;
- Bronchopleural fistula;
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 |
|---|---|---|
| esophageal and pleural pressure measurementEsophageal pressure will be monitored by a dedicated catheter and pleural pressure will be measured into the chest tube already in place | Other | Patients |
Primary outcome
End-expiratory esophageal
Time frame: Up to 2 hours from the beginning of the study
End-expiratory PES and PL, calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts;
Pleural pressure
Time frame: Up to 2 hours from the beginning of the study
PPL, directly measured in the existing chest tubes, and calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts.
transpulmonary pressures
Time frame: Up to 2 hours from the beginning of the study
1 secondary outcome
The Elastance-derived end-inspiratory transpulmonary pressure
Time frame: Up to 2 hours from the beginning of the study
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 Aug 2018.
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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?
A study testing esophageal and pleural pressure measurement in people with 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 10 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 Aug 2018. 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?
End-expiratory esophageal (time frame: Up to 2 hours from the beginning of the study). The study lists 3 primary outcomes in all. 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 Aug 2018.