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

NCT05805293 | Unknown

• 1 other identifier: HVNI versus NIV in OHS
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Assessment of benefits of HVNI in management of obesity hypoventilation syndrome complicated with acute hypercapnic respiratory failure.
2. 2.Compare the value, safety and effectiveness of HVNI and NIV in patients with obesity hypoventilation syndrome complicated with acute hypercapnic respiratory failure.

Conditions

Obesity Hypoventilation Syndrome (OHS)

Outcome Measures

Primary Outcomes (1)

• Improvement of hypercapnia and oxygenation

  decrease rate of invasive mechanical ventilation and mortality

  Baseline

Study Arms (2)

High-Velocity Nasal Insufflation

EXPERIMENTAL

Device: High-Velocity Nasal Insufflation Therapy

Non-Invasive ventilation

EXPERIMENTAL

Device: Non-Invasive Ventilation

Interventions

High-Velocity Nasal Insufflation Therapy DEVICE

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.

High-Velocity Nasal Insufflation

Non-Invasive Ventilation DEVICE

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.

Non-Invasive ventilation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 30872398 BACKGROUND

• 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.

  PMID: 32205957 BACKGROUND

• 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.

  PMID: 31882192 BACKGROUND

• 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.

  PMID: 30642143 BACKGROUND

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Rofaida Raafat Ibrahim, Assistant lecturer

CONTACT

01062023404; rofaidaraafatchest@gmail.com

Ali Abd Elazem Hassan, professor

CONTACT

01003564805; aabdelazeem@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 7, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04