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Status unknownNCT05805293Updated Apr 7, 2023

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

An interventional study of High-Velocity Nasal Insufflation Therapy and Non-Invasive Ventilation in Obesity Hypoventilation Syndrome (OHS), sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 56 is close to the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    High-Velocity Nasal Insufflation

    Device: High-Velocity Nasal Insufflation Therapy

  • Experimental
    Non-Invasive ventilation

    Device: Non-Invasive Ventilation

Interventions

  • DeviceHigh-Velocity Nasal Insufflation Therapy

    Parameter settings for the HVNI apparatus are as follows: 1. 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. 2. FIO2 will be adjusted to maintain a SaO2 more than 90 % and relative humidity of 30-34%. 3. Temperature range of 35-37°C.

  • DeviceNon-Invasive Ventilation

    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.

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What researchers measure

Primary outcomes

  1. Improvement of hypercapnia and oxygenation

    decrease rate of invasive mechanical ventilation and mortality

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 30872398 ↗
  • 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. PubMed 32205957 ↗
  • 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. PubMed 31882192 ↗
  • 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. PubMed 30642143 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05805293
Lead sponsor
Assiut University
Responsible party
Rofaida Raafat Talaat Ibrahim (Assistant lecturer, Assiut University) — Principal investigator
First posted
Apr 7, 2023
Start date
May 1, 2023 (estimated)
Primary completion
May 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Apr 7, 2023

Study contacts

Rofaida Raafat Ibrahim, Assistant lecturer
Contact
rofaidaraafatchest@gmail.com
01062023404 ext. +2
Ali Abd Elazem Hassan, professor
Contact
aabdelazeem@yahoo.com
01003564805 ext. +2

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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