- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06489509
Distribution of Pulmonary Ventilation in Lateral Decubitus of Healthy Adults Under Non-Invasive Mechanical Ventilation
July 7, 2024 updated by: Konstantinos Grigoriadis, Attikon Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Attica
-
Athens, Attica, Greece, 12462
- Attikon University Hospital
-
Athens, Attica, Greece, 18452
- Grigoriadis Konstantinos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
• Healthy Volunteers
Exclusion Criteria:
- Chronic respiratory disease
- BMI>40
- Smoking history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Supine position
Supine experimental position
|
Positive End Expiratory Pressure 5 H2O from CPAP apparatus
Positive End Expiratory Pressure 5 H2O from CPAP apparatus
|
|
Active Comparator: Right position
Right lateral decubitus
|
Positive End Expiratory Pressure 5 H2O from CPAP apparatus
Positive End Expiratory Pressure 5 H2O from CPAP apparatus
|
|
Active Comparator: Left position
Left lateral decubitus
|
Positive End Expiratory Pressure 5 H2O from CPAP apparatus
Positive End Expiratory Pressure 5 H2O from CPAP apparatus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Up to 3 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Konstantinos Grigoriadis, Dr, PT, Attikon University Hospital
- Study Director: Anna Grigoriadou, MSc, PT, Attikon University Hospital
- Study Director: Frantzeska Frantzeskaki, MD, Attikon University Hospital
- Study Director: Ioannis Efstathiou, PT, Attikon University Hospital
- Study Chair: Iraklis Tsangaris, Professor, Attikon University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Sharma 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.
- Hurewitz 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.
- Lobo 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.
- Miura 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.
- Nishimura 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2017
Primary Completion (Actual)
July 8, 2018
Study Completion (Actual)
July 8, 2018
Study Registration Dates
First Submitted
June 26, 2024
First Submitted That Met QC Criteria
July 3, 2024
First Posted (Actual)
July 8, 2024
Study Record Updates
Last Update Posted (Actual)
July 9, 2024
Last Update Submitted That Met QC Criteria
July 7, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBD2878
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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