Distribution of Pulmonary Ventilation in Lateral Decubitus of Healthy Adults Under Non-Invasive Mechanical Ventilation

NCT06489509 | Completed DMC

• 1 other identifier: EBD2878
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Noninvasive Ventilation; Patient Positioning

Keywords

impedance tomography; distribution of ventilation; lateral decubitus; Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 3 minutes

Study Arms (3)

Supine position

ACTIVE COMPARATOR

Supine experimental position

Device: Positive End Expiratory Pressure 5 H2O; Device: Positive End Expiratory Pressure 10 H2O

Right position

ACTIVE COMPARATOR

Right lateral decubitus

Device: Positive End Expiratory Pressure 5 H2O; Device: Positive End Expiratory Pressure 10 H2O

Left position

ACTIVE COMPARATOR

Left lateral decubitus

Device: Positive End Expiratory Pressure 5 H2O; Device: Positive End Expiratory Pressure 10 H2O

Interventions

Positive End Expiratory Pressure 5 H2O DEVICE

Positive End Expiratory Pressure 5 H2O from CPAP apparatus

Left position; Right position; Supine position

Positive End Expiratory Pressure 10 H2O DEVICE

Positive End Expiratory Pressure 5 H2O from CPAP apparatus

Left position; Right position; Supine position

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Volunteers

You may not qualify if:

• Chronic respiratory disease
• BMI\>40
• Smoking history

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (2)

Attikon University Hospital

Athens, Attica, 12462, Greece

Location

Grigoriadis Konstantinos

Athens, Attica, 18452, Greece

Location

Related Publications (6)

• 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.

  PMID: 22872368 BACKGROUND

• 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.

  PMID: 26933321 BACKGROUND

• 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.

  PMID: 4055566 RESULT

• 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.

  PMID: 29430443 RESULT

• 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.

  PMID: 29945735 RESULT

• 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.

  PMID: 32086337 RESULT

Study Officials

• Konstantinos Grigoriadis, Dr

  PT, Attikon University Hospital

  PRINCIPAL INVESTIGATOR

• Anna Grigoriadou, MSc

  PT, Attikon University Hospital

  STUDY DIRECTOR

• Frantzeska Frantzeskaki

  MD, Attikon University Hospital

  STUDY DIRECTOR

• Ioannis Efstathiou

  PT, Attikon University Hospital

  STUDY DIRECTOR

• Iraklis Tsangaris

  Professor, Attikon University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of allied health professions

Model Details: The regional distribution of pulmonary ventilation was measured in the supine, right, and left lateral positions while alternating the sides to ensure randomization.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 8, 2024
• Study Start: December 6, 2017
• Primary Completion: July 8, 2018
• Study Completion: July 8, 2018
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)