NCT04427969

Brief Summary

the purpose of this study to evaluate the effect of early awake PP (prone position)application on oxygenation and intubation requirement in patients with acute respiratory failure due to coronavirus disease 2019 pneumonia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

10 days

First QC Date

June 6, 2020

Last Update Submit

November 7, 2020

Conditions

Coronavirus InfectionAcute Respiratory Failure

Keywords

coronavirus disease 2019prone position

Outcome Measures

Primary Outcomes (2)

  • intensive care unit stay

    the duration of icu stay day

    up to 28 days

  • short term mortality

    mortality percent

    up to 28 days

Secondary Outcomes (1)

  • blood gases

    up to 24 hours

Study Arms (2)

EPP

patients who applied early awake prone position for treatment with conventional oxygen supply

Behavioral: prone position

non-EPP

patient who only get conventional oxygen therapy as respiratory supply

Interventions

prone positionBEHAVIORAL

to lay in prone position at least 12 hour in a day at ICU

EPP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The data of patients over 18 years old who were followed up and treated in the intensive care unit due to acute respiratory failure due to coronavirus disease 2019 pneumonia were retrospectively reviewed.

You may qualify if:

  • Patients who developed acute respiratory failure due to coronavirus disease 2019 pneumonia
  • received conventional oxygen therapy with reservoir mask oxygen at the stage of admission to the intensive care unit
  • older than 18 years old

You may not qualify if:

  • patients with respiratory acidosis,
  • partial oxygen pressure/fraction of inspired oxygen ratio below 150,
  • Glasgow Coma Score (GKS) below 12 points,
  • hemodynamic instability,
  • primary pulmonary pathologies other than pneumonia (lung cancer, cardiopulmonary edema, carcinogen syndrome, etc.)
  • patients who underwent non-invasive mechanical ventilation(NIMV) or intubated from admission to intensive care,
  • those who underwent self prone position under 12 hours were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Etfal Research and Training Hospital

Istanbul, Marmara, 34400, Turkey (Türkiye)

Location

Related Publications (4)

  • Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

    PMID: 32007143RESULT

  • Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

    PMID: 23688302RESULT

  • Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.

    PMID: 26493592RESULT

  • Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.

    PMID: 29068269RESULT

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • ayse surhan cinar

    chief of anesthesia department

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
spercialist medical doctor

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 11, 2020

Study Start

June 15, 2020

Primary Completion

June 25, 2020

Study Completion

June 30, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)