Respiratory FailureNIVEIT-pedNCT05495477
Effects of NIV and CPAP on Ventilation Distribution, Measured by EIT, During Deep Sedation in Paediatric Patients
A study testing EIT in people with Respiratory Failure and Sedation, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
In patients undergoing spontaneous breathing (SB) deep sedation there is a re-distribution of ventilation towards lungs non-dependant areas (ventral areas in supine position). Non-invasive ventilation (NIV), offering positive pressure, should favour a better ventilation of dependant areas (dorsal areas in supine… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Respiratory Failure, Sedation, Mechanical Ventilation Complication
- What is being tested?
- EIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2021to 30 Oct 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 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Paediatric age (from 1 to 10 years old)
- ASA score ≤ 2
- Sedation time ≥ 30 min
Who cannot join
- ASA score ≥ 3
- Lung pathologies (such as asthma, bronchopulmonary dysplasia, obstructive sleep apnoea) Preterm infant
- Severe obesity
- Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis)
- Neuromuscular, mitochondrial, metabolic or chromosomal disease with hypotonia
- CPAP or NIV treatment at home
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- Hand-Bag Ventilation (HBV) during the procedure (loss of the respiratory drive)
- Non-Total IntraVenous Anaesthesia (TIVA), adherence to the sedation protocol
- Implantable devices not compatible with EIT (such as pace-makers and implantable cardioverter defibrillator)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano
Milan, 20122
Giovanna Chidini, MD, 0255032242, giovanna.chidini@policlinico.mi.it
Giovanna Chidini, MD
About this study
Official title: Effects of Non-invasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) on Ventilation Distribution, Measured by Electrical Impedance Tomography (EIT), During Deep Sedation in Paediatric Patients
In patients undergoing spontaneous breathing (SB) deep sedation there is a re-distribution of ventilation towards lungs non-dependant areas (ventral areas in supine position).
Non-invasive ventilation (NIV), offering positive pressure, should favour a better ventilation of dependant areas (dorsal areas in supine position), making ventilation more homogeneous and increasing functional residual capacity.
Read more
Electrical impedance tomography (EIT) is a non-invasive, non-operator dependent, bedside, radiations-free diagnostic tool, feasible in paediatric patients and repeatable; it allows to study ventilation distribution, and it can measure and calculate also parameters that are related to the homogeneity of ventilation and the response to certain therapeutic maneuvers, such as anaesthesia or PEEP-application.
Uses of EIT in paediatric age are described in literature, but it has never been described as being used in Non-Operating Room Anaesthesia, nor in other cases of SB deep sedation. In addition, the impact of NIV on the distribution of ventilation in healthy paediatric patients undergoing deep sedation has never been described.
- Being tested
- EIT
- Keywords
- NIV; CPAP; EIT;
- Medical subject headings
- Respiratory Insufficiency, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EITDevice
Evaluation of ventilation distrinution during deep sedation through EIT
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous breathing | Active comparator | Electrical impedance tomography (EIT). Receives: Device: EIT |
| CPAP mode | Active comparator | Electrical impedance tomography (EIT). Receives: Device: EIT |
| NIV- S/T mode | Active comparator | Electrical impedance tomography (EIT). Receives: Device: EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Ventilation Delay (pixels %), RDV
It's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation
Measured: 1 day
Secondary outcomes (2)
Inhomogeneity Index (pixels), GI
Measured: 1 day
Gravity Centre(pixels %), GC
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start20 Apr 2021
- Primary completion28 Jun 2023 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanna Chidini, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495477
- Sponsor's protocol ID
- 2021/2178
- Acronym
- NIVEIT-ped
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leonhardt S, Lachmann B. Electrical impedance tomography: the holy grail of ventilation and perfusion monitoring? Intensive Care Med. 2012 Dec;38(12):1917-29. doi: 10.1007/s00134-012-2684-z. Epub 2012 Sep 20.
PubMed 22992946Zhao Z, Moller K, Steinmann D, Frerichs I, Guttmann J. Evaluation of an electrical impedance tomography-based Global Inhomogeneity Index for pulmonary ventilation distribution. Intensive Care Med. 2009 Nov;35(11):1900-6. doi: 10.1007/s00134-009-1589-y. Epub 2009 Aug 4.
PubMed 19652949Spinelli E, Mauri T, Fogagnolo A, Scaramuzzo G, Rundo A, Grieco DL, Grasselli G, Volta CA, Spadaro S. Electrical impedance tomography in perioperative medicine: careful respiratory monitoring for tailored interventions. BMC Anesthesiol. 2019 Aug 7;19(1):140. doi: 10.1186/s12871-019-0814-7.
PubMed 31390977Bordes J, Goutorbe P, Cungi PJ, Boghossian MC, Kaiser E. Noninvasive ventilation during spontaneous breathing anesthesia: an observational study using electrical impedance tomography. J Clin Anesth. 2016 Nov;34:420-6. doi: 10.1016/j.jclinane.2016.04.016. Epub 2016 Jun 16.
PubMed 27687426Humphreys S, Pham TM, Stocker C, Schibler A. The effect of induction of anesthesia and intubation on end-expiratory lung level and regional ventilation distribution in cardiac children. Paediatr Anaesth. 2011 Aug;21(8):887-93. doi: 10.1111/j.1460-9592.2011.03547.x. Epub 2011 Mar 14.
PubMed 21395895Chidini G, Marchesi T, Catenacci SS, Florio G, Conti G, Lanni S, Filocamo G, Patria F, Guerrini M, Milani G, Grasselli G. Effects of Noninvasive Respiratory Support on Ventilation Distribution During Spontaneous Breathing Sedation in Preschool/School-Aged Children: An Electrical Impedance Tomography Study. Paediatr Anaesth. 2025 Jul;35(7):562-572. doi: 10.1111/pan.15098. Epub 2025 Mar 22.
PubMed 40119601
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) on Ventilation Distribution, Measured by Electrical Impedance Tomography (EIT), During Deep Sedation in Paediatric Patients
- ClinicalTrials.gov ID
- NCT05495477
- Acronym / sponsor ID
- NIVEIT-ped / 2021/2178
- Keywords
- NIV; CPAP; EIT;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 28 Jun 2023 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 10 Aug 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.
In patients undergoing spontaneous breathing (SB) deep sedation there is a re-distribution of ventilation towards lungs non-dependant areas (ventral areas in supine position).
Non-invasive ventilation (NIV), offering positive pressure, should favour a better ventilation of dependant areas (dorsal areas in supine position), making ventilation more homogeneous and increasing functional residual capacity.
Electrical impedance tomography (EIT) is a non-invasive, non-operator dependent, bedside, radiations-free diagnostic tool, feasible in paediatric patients and repeatable; it allows to study ventilation distribution, and it can measure and calculate also parameters that are related to the homogeneity of ventilation and the response to certain therapeutic maneuvers, such as anaesthesia or PEEP-application.
Uses of EIT in paediatric age are described in literature, but it has never been described as being used in Non-Operating Room Anaesthesia, nor in other cases of SB deep sedation. In addition, the impact of NIV on the distribution of ventilation in healthy paediatric patients undergoing deep sedation has never been described.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing | Active comparator | Device: EITElectrical impedance tomography (EIT). |
| CPAP mode | Active comparator | Device: EITElectrical impedance tomography (EIT). |
| NIV- S/T mode | Active comparator | Device: EITElectrical impedance tomography (EIT). |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Paediatric age (from 1 to 10 years old)
- ASA score ≤ 2
- Sedation time ≥ 30 min
Key exclusion criteria (9 listed)
- ASA score ≥ 3
- Lung pathologies (such as asthma, bronchopulmonary dysplasia, obstructive sleep apnoea) Preterm infant
- Severe obesity
- Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis)
- Neuromuscular, mitochondrial, metabolic or chromosomal disease with hypotonia
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 |
|---|---|---|
| EITEvaluation of ventilation distrinution during deep sedation through EIT | Device | CPAP mode, NIV- S/T mode, Spontaneous breathing |
Primary outcome
Regional Ventilation Delay (pixels %), RDV
Time frame: 1 day
It's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation
2 secondary outcomes
Inhomogeneity Index (pixels), GI
Time frame: 1 day
Gravity Centre(pixels %), GC
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Background: PubMed 22992946Leonhardt S, Lachmann B. Electrical impedance tomography: the holy grail of ventilation and perfusion monitoring? Intensive Care Med. 2012 Dec;38(12):1917-29. doi: 10.1007/s00134-012-2684-z. Epub 2012 Sep 20.
- Background: PubMed 19652949Zhao Z, Moller K, Steinmann D, Frerichs I, Guttmann J. Evaluation of an electrical impedance tomography-based Global Inhomogeneity Index for pulmonary ventilation distribution. Intensive Care Med. 2009 Nov;35(11):1900-6. doi: 10.1007/s00134-009-1589-y. Epub 2009 Aug 4.
- Background: PubMed 31390977Spinelli E, Mauri T, Fogagnolo A, Scaramuzzo G, Rundo A, Grieco DL, Grasselli G, Volta CA, Spadaro S. Electrical impedance tomography in perioperative medicine: careful respiratory monitoring for tailored interventions. BMC Anesthesiol. 2019 Aug 7;19(1):140. doi: 10.1186/s12871-019-0814-7.
- Background: PubMed 27687426Bordes J, Goutorbe P, Cungi PJ, Boghossian MC, Kaiser E. Noninvasive ventilation during spontaneous breathing anesthesia: an observational study using electrical impedance tomography. J Clin Anesth. 2016 Nov;34:420-6. doi: 10.1016/j.jclinane.2016.04.016. Epub 2016 Jun 16.
- Background: PubMed 21395895Humphreys S, Pham TM, Stocker C, Schibler A. The effect of induction of anesthesia and intubation on end-expiratory lung level and regional ventilation distribution in cardiac children. Paediatr Anaesth. 2011 Aug;21(8):887-93. doi: 10.1111/j.1460-9592.2011.03547.x. Epub 2011 Mar 14.
- Derived from this study: PubMed 40119601Chidini G, Marchesi T, Catenacci SS, Florio G, Conti G, Lanni S, Filocamo G, Patria F, Guerrini M, Milani G, Grasselli G. Effects of Noninvasive Respiratory Support on Ventilation Distribution During Spontaneous Breathing Sedation in Preschool/School-Aged Children: An Electrical Impedance Tomography Study. Paediatr Anaesth. 2025 Jul;35(7):562-572. doi: 10.1111/pan.15098. Epub 2025 Mar 22.
- 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.
Giovanna Chidini principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT in people with Respiratory Failure and Sedation, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 9 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 10 Aug 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 Italy. 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?
Contact Giovanna Chidini, MD (0255032242, giovanna.chidini@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Ventilation Delay (pixels %), RDV (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495477, which also lists 6 linked publications.
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 10 Aug 2022.