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A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure

Primary Purpose

Respiratory Failure, ICU

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
prone positioning
Sponsored by
Montaser Gamal Ahmed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure, ICU

Eligibility Criteria

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

Inclusion Criteria: patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation. Exclusion Criteria: Patients will be excluded from the study if they : had received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and Pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Group-1: prone positioning + standard treatment

    Group-2: Standard treatment only

    Arm Description

    Patients randomized to the intervention group will be subjected to awake prone positioning. The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU. The treating team will supervise patients who could move themselves during the prone positioning process and assist the patients with positioning as required.

    Patients randomized to the control group, and their treating team, will be informed of their group assignment. Nurses instruct patients not to position themselves in the prone position.

    Outcomes

    Primary Outcome Measures

    Number of participants within intervention arm whom need endotracheal intubation.
    Intubation is needed when one major criterion including (cardiac or respiratory arrest; hemodynamic instability, life threatening arrhythmias, inability to protect the airway; coma or psychomotor agitation and intolerance to NIV interface; and two of the following minor criteria: RR> 35/min., PaO2/FiO2<200 mmHg, and respiratory acidosis (pH<7.30)).

    Secondary Outcome Measures

    Number of days on a ventilator.
    weaning considered successful if patient is able to achieve the following within 48 hours: pH >7.35, Decrease in PaCO2 of >15-20%, PaO2>60 mmHg, SaO2> 90% on FiO2 <40%, Respiratory rate < 24 bpm and No signs of respiratory distress like agitation, diaphoresis or anxiety.
    mortality.
    Length of ICU stay in days.
    duration of ICU stay from time of admission till discharge from ICU in days.
    Length of hospital stay in days.

    Full Information

    First Posted
    December 30, 2022
    Last Updated
    January 15, 2023
    Sponsor
    Montaser Gamal Ahmed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05698004
    Brief Title
    A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
    Official Title
    A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Montaser Gamal Ahmed

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Patients admitted to the ICU with severe hypoxemia are at high risk for mortality. Few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. Prone positioning is a technique used to help patients with acute respiratory distress syndrome breathe better. There is high degree of uncertainty on its effects on clinical outcomes in non-intubated patients with acute hypoxemia and larger studies are needed.
    Detailed Description
    we plan to study the effect of prone positioning versus standard treatment in non-intubated patients with acute hypoxemia admitted at Respiratory Intensive Care Unit (RICU), Chest Department, Assiut University Hospital, Egypt.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Patients with acute hypoxemic respiratory failure attending the participating centres will receive either prone positioning + standard treatment or standard treatment only. All new acute hypoxemic respiratory failure patients will receive prone positioning + standard treatment for the first two weeks of the study. During the following two weeks, all new patients will receive standard treatment only. These cycles will be repeated until completion the study.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    244 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group-1: prone positioning + standard treatment
    Arm Type
    Active Comparator
    Arm Description
    Patients randomized to the intervention group will be subjected to awake prone positioning. The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU. The treating team will supervise patients who could move themselves during the prone positioning process and assist the patients with positioning as required.
    Arm Title
    Group-2: Standard treatment only
    Arm Type
    No Intervention
    Arm Description
    Patients randomized to the control group, and their treating team, will be informed of their group assignment. Nurses instruct patients not to position themselves in the prone position.
    Intervention Type
    Other
    Intervention Name(s)
    prone positioning
    Intervention Description
    The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU.
    Primary Outcome Measure Information:
    Title
    Number of participants within intervention arm whom need endotracheal intubation.
    Description
    Intubation is needed when one major criterion including (cardiac or respiratory arrest; hemodynamic instability, life threatening arrhythmias, inability to protect the airway; coma or psychomotor agitation and intolerance to NIV interface; and two of the following minor criteria: RR> 35/min., PaO2/FiO2<200 mmHg, and respiratory acidosis (pH<7.30)).
    Time Frame
    30 days of randomization.
    Secondary Outcome Measure Information:
    Title
    Number of days on a ventilator.
    Description
    weaning considered successful if patient is able to achieve the following within 48 hours: pH >7.35, Decrease in PaCO2 of >15-20%, PaO2>60 mmHg, SaO2> 90% on FiO2 <40%, Respiratory rate < 24 bpm and No signs of respiratory distress like agitation, diaphoresis or anxiety.
    Time Frame
    30 days of randomization.
    Title
    mortality.
    Time Frame
    60 days of randomization.
    Title
    Length of ICU stay in days.
    Description
    duration of ICU stay from time of admission till discharge from ICU in days.
    Time Frame
    60 days of randomization.
    Title
    Length of hospital stay in days.
    Time Frame
    60 days of randomization.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation. Exclusion Criteria: Patients will be excluded from the study if they : had received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and Pregnancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Montaser Gamal
    Phone
    01008951058
    Email
    montaser_zahran@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aliae AR Mohamed Hussein
    Email
    aliaehussein@gamil.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sahar Refaat Mahmoud
    Organizational Affiliation
    Assuit university hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sarah Mohamed Hashem Hamza.
    Organizational Affiliation
    Assuit university hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Emad Zareef
    Organizational Affiliation
    Assuit university hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26903337
    Citation
    Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
    Results Reference
    background
    PubMed Identifier
    30872586
    Citation
    Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.
    Results Reference
    background
    PubMed Identifier
    24134414
    Citation
    Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
    Results Reference
    background

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    A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure

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