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HVNI Versus NIV In Management Of Acute Hypercapnic Respiratory Failure In OHS

Primary Purpose

Obesity Hypoventilation Syndrome (OHS)

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

About this trial

This is an interventional treatment trial for Obesity Hypoventilation Syndrome (OHS)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age >18 years. Obesity hypoventilation syndrome with acute hypercapnic respiratory failure. A) Body mass index [BMI] ≥ 30 kg/m2. B) Daytime hypercapnia (PaCO2 > 45 mm Hg) C) PH < 7.35 D) Arterial oxygen saturation (SaO2) <90% Exclusion Criteria: Age <18 years. Pulmonary infiltrates suggesting pulmonary edema, pneumonia, active tuberculosis, or its sequelae. Patients with gas exchange alterations due to other conditions, such as bronchiectasis, fibrosis of the pleural space (fibrothorax), neuromuscular disease and chronic obstructive pulmonary disease (COPD) Pregnancy. Contraindications for positive-airway pressure devices.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    High-Velocity Nasal Insufflation

    Non-Invasive ventilation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Improvement of hypercapnia and oxygenation
    decrease rate of invasive mechanical ventilation and mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    March 25, 2023
    Last Updated
    April 6, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05805293
    Brief Title
    HVNI Versus NIV In Management Of Acute Hypercapnic Respiratory Failure In OHS
    Official Title
    High-Velocity Nasal Insufflation Therapy Versus Non-Invasive Ventilation In Management Of Acute Hypercapnic Respiratory Failure In Obesity Hypoventilation Syndrome: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (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
    Assessment of benefits of HVNI in management of obesity hypoventilation syndrome complicated with acute hypercapnic respiratory failure. Compare the value, safety and effectiveness of HVNI and NIV in patients with obesity hypoventilation syndrome complicated with acute hypercapnic respiratory failure.
    Detailed Description
    Obesity has become a worldwide health concern. Moreover, obese patients often present comorbidities, such as obstructive apnea syndrome or obesity hypoventilation syndrome. Atelectasis formation is increased in obese patients, because of the negative effects of thoracic wall weight and abdominal fat mass on pulmonary compliance, leading to decreased functional residual capacity (FRC) and arterial oxygenation. The repetitive occurrence of rapid eye movement (REM) sleep, hypoventilation or obstructive sleep apnea with long-lasting apnea and hypopnea induces a secondary depression of respiratory drive with daytime hypercapnia, leading to obesity hypoventilation syndrome. Obesity hypoventilation syndrome is defined as a combination of obesity (body mass index [BMI] ≥ 30 kg/m2), daytime hypercapnia (PaCO2 > 45 mm Hg), and disordered breathing during sleep. Obese patients represent a specific population in the intensive care unit. Obese patients can be admitted in a critical care setting for de novo acute respiratory failure, 'acute-on-chronic' respiratory failure with an underlying disease, such as an obesity hypoventilation syndrome, or in the perioperative period. The main challenges for ICU clinicians are to take into account the pulmonary pathophysiological specificities of the obese patient to optimize airway management and non-invasive or invasive mechanical ventilation. Noninvasive ventilation (NIV) has revolutionized the management of acute respiratory failure. NIV obviates endotracheal intubation and thus decreases the risk of ventilator-induced pneumonia, shortens ICU stay, and decreases the overall cost of hospitalization. Oxygen delivery through high flow nasal cannula (HFNC) has used for the treatment of certain hypoxic situations like bronchiolitis in neonate. HFNC acts as non-invasive ventilator by reducing airway resistance and improving CO2 clearance by providing positive end-expiratory pressure (PEEP). Therefore, it is feasible to employ NFC in the case of obstructive pulmonary diseases. Since HFNC can open the airway by inducing stenting effects, it supplies more effective oxygenation with stable fraction of inspired oxygen (FIO2) in the range of 21 to 100% and a flow rate of up to 60 L/min. High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small-bore nasal cannula to generate higher velocities of gas delivery than its counterparts using large bore HFNC, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 liters/min and may be able to provide ventilatory support in patients with acute hypercapnic respiratory failure in addition to oxygenation support.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity Hypoventilation Syndrome (OHS)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High-Velocity Nasal Insufflation
    Arm Type
    Experimental
    Arm Title
    Non-Invasive ventilation
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    High-Velocity Nasal Insufflation Therapy
    Intervention Description
    Parameter settings for the HVNI apparatus are as follows: The flow of HVNI will initially be set at 30-40 L/min, and inspiratory flow rate could be increased to 45-60 L/min. FIO2 will be adjusted to maintain a SaO2 more than 90 % and relative humidity of 30-34%. Temperature range of 35-37°C.
    Intervention Type
    Device
    Intervention Name(s)
    Non-Invasive Ventilation
    Intervention Description
    Patients will be put on inspiratory/expiratory pressure 10/5 cmH2O (11). The inspiratory and expiratory pressures will be titrated with increments of 2 cmH2O based on improvement of oxygen saturation by continuous pulse oximetry and arterial blood gases values, alleviation of dyspnea and a decrease of respiratory rate and heart rate. The maximum allowed inspiratory pressure was 20 cm H2O. The maximum allowed expiratory pressure was 10 cm H2O.
    Primary Outcome Measure Information:
    Title
    Improvement of hypercapnia and oxygenation
    Description
    decrease rate of invasive mechanical ventilation and mortality
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >18 years. Obesity hypoventilation syndrome with acute hypercapnic respiratory failure. A) Body mass index [BMI] ≥ 30 kg/m2. B) Daytime hypercapnia (PaCO2 > 45 mm Hg) C) PH < 7.35 D) Arterial oxygen saturation (SaO2) <90% Exclusion Criteria: Age <18 years. Pulmonary infiltrates suggesting pulmonary edema, pneumonia, active tuberculosis, or its sequelae. Patients with gas exchange alterations due to other conditions, such as bronchiectasis, fibrosis of the pleural space (fibrothorax), neuromuscular disease and chronic obstructive pulmonary disease (COPD) Pregnancy. Contraindications for positive-airway pressure devices.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rofaida Raafat Ibrahim, Assistant lecturer
    Phone
    01062023404
    Ext
    +2
    Email
    rofaidaraafatchest@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ali Abd Elazem Hassan, professor
    Phone
    01003564805
    Ext
    +2
    Email
    aabdelazeem@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30872398
    Citation
    Masa JF, Pepin JL, Borel JC, Mokhlesi B, Murphy PB, Sanchez-Quiroga MA. Obesity hypoventilation syndrome. Eur Respir Rev. 2019 Mar 14;28(151):180097. doi: 10.1183/16000617.0097-2018. Print 2019 Mar 31.
    Results Reference
    background
    PubMed Identifier
    32205957
    Citation
    Chawla R, Dixit SB, Zirpe KG, Chaudhry D, Khilnani GC, Mehta Y, Khatib KI, Jagiasi BG, Chanchalani G, Mishra RC, Samavedam S, Govil D, Gupta S, Prayag S, Ramasubban S, Dobariya J, Marwah V, Sehgal I, Jog SA, Kulkarni AP. ISCCM Guidelines for the Use of Non-invasive Ventilation in Acute Respiratory Failure in Adult ICUs. Indian J Crit Care Med. 2020 Jan;24(Suppl 1):S61-S81. doi: 10.5005/jp-journals-10071-G23186.
    Results Reference
    background
    PubMed Identifier
    31882192
    Citation
    Fernandez Alvarez R, Belda Ramirez J, Rubinos Cuadrado G, Buchelli Ramirez H, Fole Vazquez D, Iscar Urrutia M, Rodriguez Jerez F, Vazquez Lopez MJ, Casan Clara P. Obesity-Hypoventilation Syndrome: Baseline Hemodynamic Status and Impact of non-Invasive Ventilation. Arch Bronconeumol (Engl Ed). 2020 Jul;56(7):441-445. doi: 10.1016/j.arbres.2019.08.022. Epub 2019 Dec 25. English, Spanish.
    Results Reference
    background
    PubMed Identifier
    30642143
    Citation
    Nicolini A, Ferrando M, Solidoro P, Di Marco F, Facchini F, Braido F. Non-invasive ventilation in acute respiratory failure of patients with obesity hypoventilation syndrome. Minerva Med. 2018 Dec;109(6 Suppl 1):1-5. doi: 10.23736/S0026-4806.18.05921-9.
    Results Reference
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    HVNI Versus NIV In Management Of Acute Hypercapnic Respiratory Failure In OHS

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