Clinical trial NCT05805293: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity Hypoventilation Syndrome (OHS)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Assessment of benefits of HVNI in management of obesity hypoventilation syndrome complicated with acute hypercapnic respiratory failure.
2. 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.

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years.
2. 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:

1. Age \<18 years.
2. Pulmonary infiltrates suggesting pulmonary edema, pneumonia, active tuberculosis, or its sequelae.
3. 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)
4. Pregnancy.
5. Contraindications for positive-airway pressure devices.

Primary outcomes:
measure: Improvement of hypercapnia and oxygenation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.