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Prone Positioning in COVID-19 Patients

Primary Purpose

Coronavirus Disease 2019, ARDS, Mechanical Ventilation Pressure High

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Oxygenation

About this trial

This is an interventional screening trial for Coronavirus Disease 2019

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients with laboratory-confirmed COVID-19 admitted to the ICU
The patients receive invasive mechanical ventilation and meet the criteria for ARDS (Berlin definition) (8), with under continuous infusion of sedatives,

Exclusion Criteria:

Pregnancy
Pneumothorax and or chest tube
Chronic obstructive lung disease
interstitial lung disease
intraabdominal hypertension
increase in intracranial blood pressure
Haemodynamic unstability requiring vasopressors

Sites / Locations

Kazim RollasRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prone Positioning

Arm Description

Patients will be ventilated in volume-controlled mode with Vt at 6 ml/kg of predicted body weight. Prone positioning will be performed over periods of 16 hours when PaO2/FiO2 was persistently lower than 150 mm Hg. Flow, volume, and airway pressure will bw measured by ventilators. Measurements of oxygenation and respiratory mechanics were performed at 5 and 15 cmH20 PEEP levels and will be repeated every season as before first period of prone positioning, before supine positioning, and again before second period of prone positioning. Total PEEP and plateau pressure will be measured by a short end-expiratory and an end-inspiratory occlusion respectively. Complete airway closure will be assessed by performing a low-flow (4 L/min) inflation( PV tool) (9). The potential for lung recruitment will be assessed by means of the R/I ratio (10).

Outcomes

Primary Outcome Measures

Oxygenation

PaO2/FiO2

Secondary Outcome Measures

Static compliance

Tidal volume divided driving pressure

Recruitability

recruitment to inflation ratio

Full Information

NCT ID

NCT05150847

First Posted

December 7, 2021

Last Updated

January 31, 2022

Sponsor

Tepecik Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05150847

Brief Title

Prone Positioning in COVID-19 Patients

Official Title

The Effect of Prone Positioning on Oxygenation and Respiratory Mechanics in Patients With COVID-19 Pneumonia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 25, 2021 (Actual)

Primary Completion Date

February 1, 2022 (Actual)

Study Completion Date

April 13, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tepecik Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3). The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6). Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7). Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the recruitability position of the lung.in COVID-ARDS.

Detailed Description

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3). The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6). Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the oxygenation, respiratory mechanics and recruitability position of the lung in COVID-ARDS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Disease 2019, ARDS, Mechanical Ventilation Pressure High

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prone Positioning

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Oxygenation

Other Intervention Name(s)

static compliance, Recruitability

Intervention Description

Oxygenation will be calculated as PaO2/ FiO2 ratio.Static compliance will be calculated as tidal volume divided driving pressure.The potential for lung recruitment will be assessed by means of the R/I ratio (10).

Primary Outcome Measure Information:

Title

Oxygenation

Description

PaO2/FiO2

Time Frame

intubation + 48 hours

Secondary Outcome Measure Information:

Title

Static compliance

Description

Tidal volume divided driving pressure

Time Frame

intubation + 48 hours

Title

Recruitability

Description

recruitment to inflation ratio

Time Frame

intubation + 48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients with laboratory-confirmed COVID-19 admitted to the ICU The patients receive invasive mechanical ventilation and meet the criteria for ARDS (Berlin definition) (8), with under continuous infusion of sedatives, Exclusion Criteria: Pregnancy Pneumothorax and or chest tube Chronic obstructive lung disease interstitial lung disease intraabdominal hypertension increase in intracranial blood pressure Haemodynamic unstability requiring vasopressors

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

KAZIM ROLLAS

Phone

+905532787535

kazim.rollas@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

ÖMER EMGİN

Phone

+905532787535

ömer.emgin@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Işıl Köse Güldoğan

Organizational Affiliation

İzmi̇r Tepeci̇k Eği̇ti̇m Ve Arştırma Hastanesi̇

Official's Role

Study Chair

Facility Information:

Facility Name

Kazim Rollas

City

İzmir

ZIP/Postal Code

55327

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

KAZIM ROLLAS

Phone

+905532787535

kazim.rollas@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Will be shared as the first patient included in the study

IPD Sharing Time Frame

From 25 december - 3 months

Citations:

PubMed Identifier

16556697

Citation

Mancebo J, Fernandez R, Blanch L, Rialp G, Gordo F, Ferrer M, Rodriguez F, Garro P, Ricart P, Vallverdu I, Gich I, Castano J, Saura P, Dominguez G, Bonet A, Albert RK. A multicenter trial of prolonged prone ventilation in severe acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Jun 1;173(11):1233-9. doi: 10.1164/rccm.200503-353OC. Epub 2006 Mar 23.

Results Reference

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PubMed Identifier

15547166

Citation

Guerin C, Gaillard S, Lemasson S, Ayzac L, Girard R, Beuret P, Palmier B, Le QV, Sirodot M, Rosselli S, Cadiergue V, Sainty JM, Barbe P, Combourieu E, Debatty D, Rouffineau J, Ezingeard E, Millet O, Guelon D, Rodriguez L, Martin O, Renault A, Sibille JP, Kaidomar M. Effects of systematic prone positioning in hypoxemic acute respiratory failure: a randomized controlled trial. JAMA. 2004 Nov 17;292(19):2379-87. doi: 10.1001/jama.292.19.2379.

Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

34362368

Citation

Park J, Lee HY, Lee J, Lee SM. Effect of prone positioning on oxygenation and static respiratory system compliance in COVID-19 ARDS vs. non-COVID ARDS. Respir Res. 2021 Aug 6;22(1):220. doi: 10.1186/s12931-021-01819-4.

Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Results Reference

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Prone Positioning in COVID-19 Patients

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