Noninvasive VentilationNCT06489509
Distribution of Pulmonary Ventilation in Lateral Decubitus of Healthy Adults Under Non-Invasive Mechanical Ventilation
A study testing Positive End Expiratory Pressure 5 H2O and Positive End Expiratory Pressure 10 H2O in people with Noninvasive Ventilation and Patient Positioning, run by Attikon Hospital at 2 sites in Greece.
Trial summary
The aim was to investigate via impedance tomography apparatus the distribution of pulmonary ventilation at a lateral position at different Continuous Positive Airway Pressure levels (0, 5, 10 cm Η2Ο) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Noninvasive Ventilation, Patient Positioning
- What is being tested?
- Positive End Expiratory Pressure 5 H2O and Positive End Expiratory Pressure 10 H2O
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesGreece
- Study dates
- 6 Dec 2017to 8 Jul 2018
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers
Who cannot join
- Chronic respiratory disease
- BMI>40
- Smoking history
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Attikon University Hospital
Athens, Attica, 12462
Grigoriadis Konstantinos
Athens, Attica, 18452
About this study
Official title: Distribution of Pulmonary Ventilation in Lateral Decubitus of Healthy Adults Under Non-Invasive Mechanical Ventilation Supply
The aim was to investigate via impedance tomography apparatus the distribution of pulmonary ventilation at a lateral position at different Continuous Positive Airway Pressure levels (0, 5, 10 cm Η2Ο) in healthy subjects.
Read the detailed description
In lateral decubitus, the largest percentage of pulmonary ventilation of non-sedated subjects is distributed mainly in the dependent lung. The aim It was to investigate via impedance tomography apparatus the distribution of pulmonary ventilation at a lateral position at different Continuous Positive Airway Pressure levels (0, 5, 10 cm Η2Ο) in healthy subjects. The volunteers were noninvasively ventilated in both lateral positions and supine positions at the beginning and end of the process. It is concluded that implementing Non-Invasive Ventilation in the lateral body position resulted in increased ventilation of the dependent lung. In contrast, the respective ventilation of the non-dependent lung was further decreased.
- Conditions
- Noninvasive Ventilation, Patient Positioning
- Being tested
- Positive End Expiratory Pressure 5 H2O, Positive End Expiratory Pressure 10 H2O
- Keywords
- impedance tomography, distribution of ventilation, lateral decubitus, Noninvasive Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive End Expiratory Pressure 5 H2ODevice
Positive End Expiratory Pressure 5 H2O from CPAP apparatus
Positive End Expiratory Pressure 10 H2ODevice
Positive End Expiratory Pressure 5 H2O from CPAP apparatus
| Study group | Role | What they receive |
|---|---|---|
| Supine position | Active comparator | Supine experimental position Receives: Device: Positive End Expiratory Pressure 5 H2O; Device: Positive End Expiratory Pressure 10 H2O |
| Right position | Active comparator | Right lateral decubitus Receives: Device: Positive End Expiratory Pressure 5 H2O; Device: Positive End Expiratory Pressure 10 H2O |
| Left position | Active comparator | Left lateral decubitus Receives: Device: Positive End Expiratory Pressure 5 H2O; Device: Positive End Expiratory Pressure 10 H2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change in pulmonary ventilation
The percentage change in pulmonary ventilation was measured at each position, without applying external positive end-expiratory pressure and under positive end-expiratory pressure of 5 and 10 cmH2O
Measured: Up to 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start6 Dec 2017
- Primary completion8 Jul 2018
- Study completion8 Jul 2018
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 Noninvasive 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The regional distribution of pulmonary ventilation was measured in the supine, right, and left lateral positions while alternating the sides to ensure randomization.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Grigoriadis, Attikon Hospital
- Investigators
- Konstantinos Grigoriadis, Dr, Principal investigator, PT, Attikon University HospitalAnna Grigoriadou, MSc, Study director, PT, Attikon University HospitalFrantzeska Frantzeskaki, Study director, MD, Attikon University HospitalIoannis Efstathiou, Study director, PT, Attikon University HospitalIraklis Tsangaris, Study chair, Professor, Attikon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489509
- Sponsor's protocol ID
- EBD2878
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schnidrig S, Casaulta C, Schibler A, Riedel T. Influence of end-expiratory level and tidal volume on gravitational ventilation distribution during tidal breathing in healthy adults. Eur J Appl Physiol. 2013 Mar;113(3):591-8. doi: 10.1007/s00421-012-2469-7. Epub 2012 Aug 8.
PubMed 22872368Sharma JP, Salhotra R, Kumar S, Tyagi A, Sethi AK. Noninvasive lung recruitment maneuver prevents reintubation and reduces ICU stay. Lung India. 2016 Jan-Feb;33(1):99-101. doi: 10.4103/0970-2113.173070. No abstract available.
PubMed 26933321Hurewitz AN, Susskind H, Harold WH. Obesity alters regional ventilation in lateral decubitus position. J Appl Physiol (1985). 1985 Sep;59(3):774-83. doi: 10.1152/jappl.1985.59.3.774.
PubMed 4055566Lobo B, Hermosa C, Abella A, Gordo F. Electrical impedance tomography. Ann Transl Med. 2018 Jan;6(2):26. doi: 10.21037/atm.2017.12.06.
PubMed 29430443Miura MC, Ribeiro de Carvalho CR, Yamada da Silveira LT, de Moraes Regenga M, Petri Damiani L, Fu C. The effects of recruitment maneuver during noninvasive ventilation after coronary bypass grafting: A randomized trial. J Thorac Cardiovasc Surg. 2018 Dec;156(6):2170-2177.e1. doi: 10.1016/j.jtcvs.2018.05.004. Epub 2018 May 28.
PubMed 29945735Nishimura M. Electrical Impedance Tomography: The Promise of Noninvasive Lung Images at the Bedside. Respir Care. 2020 Mar;65(3):402-403. doi: 10.4187/respcare.07716. No abstract available.
PubMed 32086337
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Pulmonary Ventilation in Lateral Decubitus of Healthy Adults Under Non-Invasive Mechanical Ventilation Supply
- ClinicalTrials.gov ID
- NCT06489509
- Acronym / sponsor ID
- EBD2878
- Conditions
- Noninvasive Ventilation, Patient Positioning
- Keywords
- impedance tomography, distribution of ventilation, lateral decubitus, Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 8 Jul 2018 (actual)
- Study completion
- 8 Jul 2018 (actual)
- First posted
- 8 Jul 2024 (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 aim was to investigate via impedance tomography apparatus the distribution of pulmonary ventilation at a lateral position at different Continuous Positive Airway Pressure levels (0, 5, 10 cm Η2Ο) in healthy subjects.
Detailed description
In lateral decubitus, the largest percentage of pulmonary ventilation of non-sedated subjects is distributed mainly in the dependent lung. The aim It was to investigate via impedance tomography apparatus the distribution of pulmonary ventilation at a lateral position at different Continuous Positive Airway Pressure levels (0, 5, 10 cm Η2Ο) in healthy subjects. The volunteers were noninvasively ventilated in both lateral positions and supine positions at the beginning and end of the process. It is concluded that implementing Non-Invasive Ventilation in the lateral body position resulted in increased ventilation of the dependent lung. In contrast, the respective ventilation of the non-dependent lung was further decreased.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The regional distribution of pulmonary ventilation was measured in the supine, right, and left lateral positions while alternating the sides to ensure randomization.
| Arm | Type | Receives |
|---|---|---|
| Supine position | Active comparator | Device: Positive End Expiratory Pressure 5 H2O, Device: Positive End Expiratory Pressure 10 H2OSupine experimental position |
| Right position | Active comparator | Device: Positive End Expiratory Pressure 5 H2O, Device: Positive End Expiratory Pressure 10 H2ORight lateral decubitus |
| Left position | Active comparator | Device: Positive End Expiratory Pressure 5 H2O, Device: Positive End Expiratory Pressure 10 H2OLeft lateral decubitus |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Volunteers
Key exclusion criteria (3 listed)
- Chronic respiratory disease
- BMI>40
- Smoking history
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 |
|---|---|---|
| Positive End Expiratory Pressure 5 H2OPositive End Expiratory Pressure 5 H2O from CPAP apparatus | Device | Left position, Right position, Supine position |
| Positive End Expiratory Pressure 10 H2OPositive End Expiratory Pressure 5 H2O from CPAP apparatus | Device | Left position, Right position, Supine position |
Primary outcome
The percentage change in pulmonary ventilation
Time frame: Up to 3 minutes
The percentage change in pulmonary ventilation was measured at each position, without applying external positive end-expiratory pressure and under positive end-expiratory pressure of 5 and 10 cmH2O
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 9 Jul 2024.
- Background: PubMed 22872368Schnidrig S, Casaulta C, Schibler A, Riedel T. Influence of end-expiratory level and tidal volume on gravitational ventilation distribution during tidal breathing in healthy adults. Eur J Appl Physiol. 2013 Mar;113(3):591-8. doi: 10.1007/s00421-012-2469-7. Epub 2012 Aug 8.
- Background: PubMed 26933321Sharma JP, Salhotra R, Kumar S, Tyagi A, Sethi AK. Noninvasive lung recruitment maneuver prevents reintubation and reduces ICU stay. Lung India. 2016 Jan-Feb;33(1):99-101. doi: 10.4103/0970-2113.173070. No abstract available.
- Results publication: PubMed 4055566Hurewitz AN, Susskind H, Harold WH. Obesity alters regional ventilation in lateral decubitus position. J Appl Physiol (1985). 1985 Sep;59(3):774-83. doi: 10.1152/jappl.1985.59.3.774.
- Results publication: PubMed 29430443Lobo B, Hermosa C, Abella A, Gordo F. Electrical impedance tomography. Ann Transl Med. 2018 Jan;6(2):26. doi: 10.21037/atm.2017.12.06.
- Results publication: PubMed 29945735Miura MC, Ribeiro de Carvalho CR, Yamada da Silveira LT, de Moraes Regenga M, Petri Damiani L, Fu C. The effects of recruitment maneuver during noninvasive ventilation after coronary bypass grafting: A randomized trial. J Thorac Cardiovasc Surg. 2018 Dec;156(6):2170-2177.e1. doi: 10.1016/j.jtcvs.2018.05.004. Epub 2018 May 28.
- Results publication: PubMed 32086337Nishimura M. Electrical Impedance Tomography: The Promise of Noninvasive Lung Images at the Bedside. Respir Care. 2020 Mar;65(3):402-403. doi: 10.4187/respcare.07716. No abstract available.
- 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.
Konstantinos Grigoriadis, Dr principal investigator
PT, Attikon University Hospital
Anna Grigoriadou, MSc study director
PT, Attikon University Hospital
Frantzeska Frantzeskaki study director
MD, Attikon University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive End Expiratory Pressure 5 H2O and Positive End Expiratory Pressure 10 H2O in people with Noninvasive Ventilation and Patient Positioning, run by Attikon Hospital at 2 sites in Greece.
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 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 9 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 2 sites in Greece. 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?
The percentage change in pulmonary ventilation (time frame: Up to 3 minutes). 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 NCT06489509, 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 9 Jul 2024.