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Role of HVNI in Severe Chest Trauma

Primary Purpose

Chest Trauma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Velocity Nasal Insufflation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chest Trauma focused on measuring High velocity nasal insufflation

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Chest trauma patients with lung injury confirmed by ct imaging the age from 15-55 years old No indication of mechanical ventilation at the time of admission to the intensive care unit Exclusion Criteria: • Patients < 15years old requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause facial fractures or base of skull fractures Who did not receive a chest computed tomography (CT) scan Glasgow Coma Scale <10 Massive surgical emphysema COPD Patients ( chronic obstructive pulmonary disease )

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    HVNI group

    Control group

    Arm Description

    Patients will receive high velocity nasal insufflation therapy

    Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask

    Outcomes

    Primary Outcome Measures

    Incidence of atelectasis in chest trauma patients
    Incidence of atelectasis in chest trauma patients using the chest ultrasound measured by lung consolidation score.

    Secondary Outcome Measures

    respiratory complications,hospital stay and Comfort levels
    Other respiratory complications as hypoxemia and pneumonia. Need for intubation and mechanical ventilation Length of ICU and hospital stay. Comfort levels with different levels of oxygen delivery measured by Likert scale.

    Full Information

    First Posted
    January 11, 2023
    Last Updated
    January 11, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05692076
    Brief Title
    Role of HVNI in Severe Chest Trauma
    Official Title
    The Role of High Velocity Nasal Insufflation in Prevention of Respiratory Complications in Severe Chest Trauma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 20, 2023 (Anticipated)
    Primary Completion Date
    March 20, 2025 (Anticipated)
    Study Completion Date
    September 20, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    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
    to compare the respiratory complications in patient managed with high velocity nasal insufflation versus patients managed with conventional low flow oxygen in patients with severe chest trauma
    Detailed Description
    Chest trauma are associated with significant morbidity and mortality due to respiratory failure and pneumonia. The two main goals of therapy are pain management and pulmonary care and support. There is strong evidence for providing good analgesia to facilitate volume expansion treatment and chest physiotherapy, aiming for deep breathing and effective cough to reduce secretions and prevent the atelectasis. Oxygen supplementation is often included as supportive therapy added to bundles of care for patients of chest trauma with rib fractures. High -velocity nasal insufflation (HVNI ) was first developed for neonates and has gained increasing use in adult patients for prevention and treatment of respiratory failure. High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered. Positive end-expiratory pressure can be generated, preventing alveoli collapse. The washout of carbon dioxide (CO2)and replacement with enriched O2 purportedly decreases work of breathing and increases breathing effectiveness. Routine tests for chest injuries include chest X-rays and computed tomography (CT) scans. Ultrasound has the advantages of being inexpensive, readily available and being free of ionizing radiation . In thoracic trauma cases, ultrasonography of the lungs is valuable for evaluating various chest diseases, including chest wall haematoma and fractures, pleural cavity involvement with pleural effusion, haemothorax, and pneumothorax. The ultrasound can also assess the reduce in lung aeration by changing the lung surface and generating distinct patterns as in pulmonary contusions and compression atelectasis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chest Trauma
    Keywords
    High velocity nasal insufflation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    • we sought statistical advice regarding the sample size needed for the study sample size was calculated using G power program to detect significant difference. To detect the incidence of atelectasis in these patients we performed a pilot study included 15 patients using simple mask as oxygen therapy, the results showed an incidence of 50% rate of atelectasis according to the inclusion and exclusion criteria To be able to detect 30% reduction in the incidence of atelectasis we need to include 43 patients in each group Alpha error=.05, 80 % power of the study with equal group assignment Group (A) :43 patients (control group): • Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask Group (B) 43 patients ( HVNI group): • Patient will receive HVNI therapy
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HVNI group
    Arm Type
    Experimental
    Arm Description
    Patients will receive high velocity nasal insufflation therapy
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask
    Intervention Type
    Device
    Intervention Name(s)
    High Velocity Nasal Insufflation
    Intervention Description
    High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered.
    Primary Outcome Measure Information:
    Title
    Incidence of atelectasis in chest trauma patients
    Description
    Incidence of atelectasis in chest trauma patients using the chest ultrasound measured by lung consolidation score.
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    respiratory complications,hospital stay and Comfort levels
    Description
    Other respiratory complications as hypoxemia and pneumonia. Need for intubation and mechanical ventilation Length of ICU and hospital stay. Comfort levels with different levels of oxygen delivery measured by Likert scale.
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chest trauma patients with lung injury confirmed by ct imaging the age from 15-55 years old No indication of mechanical ventilation at the time of admission to the intensive care unit Exclusion Criteria: • Patients < 15years old requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause facial fractures or base of skull fractures Who did not receive a chest computed tomography (CT) scan Glasgow Coma Scale <10 Massive surgical emphysema COPD Patients ( chronic obstructive pulmonary disease )
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Yasser, Bachelor's
    Phone
    01066249910
    Email
    my3939899@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Mandour, Consultant
    Phone
    01069996336
    Email
    mando_eg_2000@aun.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24930204
    Citation
    Karim A, Arora VK. Applications of ultrasonography in respiratory intensive care. Indian J Chest Dis Allied Sci. 2014 Jan-Mar;56(1):27-31.
    Results Reference
    background
    PubMed Identifier
    11548565
    Citation
    Easter A. Management of patients with multiple rib fractures. Am J Crit Care. 2001 Sep;10(5):320-7; quiz 328-9.
    Results Reference
    background
    PubMed Identifier
    17826213
    Citation
    McGillicuddy D, Rosen P. Diagnostic dilemmas and current controversies in blunt chest trauma. Emerg Med Clin North Am. 2007 Aug;25(3):695-711, viii-ix. doi: 10.1016/j.emc.2007.06.004.
    Results Reference
    background
    PubMed Identifier
    26969671
    Citation
    Papazian L, Corley A, Hess D, Fraser JF, Frat JP, Guitton C, Jaber S, Maggiore SM, Nava S, Rello J, Ricard JD, Stephan F, Trisolini R, Azoulay E. Use of high-flow nasal cannula oxygenation in ICU adults: a narrative review. Intensive Care Med. 2016 Sep;42(9):1336-49. doi: 10.1007/s00134-016-4277-8. Epub 2016 Mar 11.
    Results Reference
    background
    PubMed Identifier
    29558988
    Citation
    Helviz Y, Einav S. A Systematic Review of the High-flow Nasal Cannula for Adult Patients. Crit Care. 2018 Mar 20;22(1):71. doi: 10.1186/s13054-018-1990-4.
    Results Reference
    background
    PubMed Identifier
    25866645
    Citation
    Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
    Results Reference
    background
    PubMed Identifier
    27375379
    Citation
    Abdalla W, Elgendy M, Abdelaziz AA, Ammar MA. Lung ultrasound versus chest radiography for the diagnosis of pneumothorax in critically ill patients: A prospective, single-blind study. Saudi J Anaesth. 2016 Jul-Sep;10(3):265-9. doi: 10.4103/1658-354X.174906.
    Results Reference
    background
    PubMed Identifier
    27035835
    Citation
    Wongwaisayawan S, Suwannanon R, Sawatmongkorngul S, Kaewlai R. Emergency Thoracic US: The Essentials. Radiographics. 2016 May-Jun;36(3):640-59. doi: 10.1148/rg.2016150064. Epub 2016 Apr 1.
    Results Reference
    background
    Links:
    URL
    https://www.intechopen.com/chapters/44472
    Description
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    Role of HVNI in Severe Chest Trauma

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