Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome

NCT04327336 | Completed

• 1 other identifier: PI16/01704
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives: To evaluate the effectiveness in the obesity hypoventilation syndrome (OHS) treatment with non-invasive ventilation (NIV) set manually by polysomnography compared to the same treatment with a respirator with automatic NIV adjustment, analyzing as primary variable PaCO2 and as operational variables dropout rate for medical reasons and mortality. Secondary objectives: cost-effectiveness, clinical and functional improvement in wakefulness and during sleep, quality of life, blood pressure monitoring for 24 hours, incidence and evolution of cardiovascular events and use of health resources. Other objectives: 1) effectiveness of treatments in the following subgroups of patients: gender, age, socioeconomic status, severity of sleep apnea, VNI compliance, quality of life and comorbidities; 2) To evaluate the profile of patients with poor adherence to NIV based on clinical severity, gender, age and socioeconomic status in the whole sample and in both intervention groups.

Conditions

Chronic Hypercapnic Respiratory Failure; Obesity Hypoventilation Syndrome

Keywords

Chronic respiratory failure; Obesity; Non invasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Change in PaCO2 between arms

  Arterial blood gases while room air breathing expressed in mmHg

  1 year

Secondary Outcomes (28)

• Cost-effectiveness analysis by primary outcome

  1 year

• Cost-effectiveness analysis by QALY

  1 year

• Change in subjective daytime sleepiness

  1 year

• Change in Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ)

  1 year

• Change in Quality of life measured by visual analogical wellbeing scale (VAWS)

  1 year

Other Outcomes (5)

• Adherent vs. non-adherent to noninvasive ventilation therapy subgroups

  1 year

• Sleep apnea severity subgroup

  1 year

• Hypercapnia severity subgroup

  1 year

Study Arms (2)

Manual

ACTIVE COMPARATOR

In this group non invasive mechanical ventilation will be manually titrated during a polysomnography. The Philips A40 ventilator will be used in Spontaneous-Timed (ST) mode.

Device: Manual Non invasive ventilation titration

Automatic

ACTIVE COMPARATOR

In this group the ventilator will run in an automatic mode (AVAPS) with the same Phillips A40 ventilator.

Device: Automatic Non invasive ventilation titration

Interventions

Manual Non invasive ventilation titration DEVICE

Manual Group: during a complete polysomnography, adding transcutaneous capnography and the basic ventilators curves, the ventilators setting will be adjusted in order to correct respiratory events and patient-ventilator asyncrony. A 10 hours face-to-face investigator training meeting is programmed before opening the inclusion period.

Manual

Automatic Non invasive ventilation titration DEVICE

Automatic Group: the A40 ventilator in the automatic AVAPS mode will be adjusted in order to achieve 8-10 ml/kg of ideal weight.

Automatic

Eligibility Criteria

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

You may qualify if:

• Obesity Hypoventilation Syndrome defined by obesity (IMC≥30) and Hypercapnic respiratory failure (PCO 2\> 45 mm Hg) in stable phase (PH≥7.35 without clinical signs of worsening in at least one previous month).
• Age between 18-80 years.
• Absence of other diseases causing hypercapnia as moderate or severe chronic obstructive pulmonary disease (FEV1\> 70% predicted if FEV1 / FVC \<70), neuromuscular, thoracic wall or metabolic disease; d) Absence of narcolepsy or restless legs syndrome.
• Overcome correctly a 30 minutes test of treatment with VNI in wakefulness.

You may not qualify if:

• Psychophysical disability for questionnaires.
• Patients who cannot be evaluated by quality of life questionnaires because they present debilitating chronic disease.
• Chronic nasal obstruction that prevents the use of NIV.
• Pregnancy.
• No informed consent obtained.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Juan F. Masa

Cáceres, 10003, Spain

Location

Related Publications (14)

• Mokhlesi B, Kryger MH, Grunstein RR. Assessment and management of patients with obesity hypoventilation syndrome. Proc Am Thorac Soc. 2008 Feb 15;5(2):218-25. doi: 10.1513/pats.200708-122MG.

  PMID: 18250215 BACKGROUND

• Nowbar S, Burkart KM, Gonzales R, Fedorowicz A, Gozansky WS, Gaudio JC, Taylor MR, Zwillich CW. Obesity-associated hypoventilation in hospitalized patients: prevalence, effects, and outcome. Am J Med. 2004 Jan 1;116(1):1-7. doi: 10.1016/j.amjmed.2003.08.022.

  PMID: 14706658 BACKGROUND

• Berg G, Delaive K, Manfreda J, Walld R, Kryger MH. The use of health-care resources in obesity-hypoventilation syndrome. Chest. 2001 Aug;120(2):377-83. doi: 10.1378/chest.120.2.377.

  PMID: 11502632 BACKGROUND

• Lopez-Jimenez MJ, Masa JF, Corral J, Teran J, Ordaz E, Troncoso MF, Gonzalez-Mangado N, Gonzalez M, Lopez-Martinez S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Diaz-de-Atauri J, Chiner E, Aizpuru F, Egea C, Romero A, Benitez JM, Sanchez-Gomez J, Golpe R, Santiago-Recuerda A, Gomez S, Barbe F, Bengoa M; Grupo cooperativo. Mid- and Long-Term Efficacy of Non-Invasive Ventilation in Obesity Hypoventilation Syndrome: The Pickwick's Study. Arch Bronconeumol. 2016 Mar;52(3):158-65. doi: 10.1016/j.arbres.2015.10.003. Epub 2015 Dec 4. English, Spanish.

  PMID: 26656679 BACKGROUND

• Masa JF, Celli BR, Riesco JA, Hernandez M, Sanchez De Cos J, Disdier C. The obesity hypoventilation syndrome can be treated with noninvasive mechanical ventilation. Chest. 2001 Apr;119(4):1102-7. doi: 10.1378/chest.119.4.1102.

  PMID: 11296176 BACKGROUND

• Perez de Llano LA, Golpe R, Ortiz Piquer M, Veres Racamonde A, Vazquez Caruncho M, Caballero Muinelos O, Alvarez Carro C. Short-term and long-term effects of nasal intermittent positive pressure ventilation in patients with obesity-hypoventilation syndrome. Chest. 2005 Aug;128(2):587-94. doi: 10.1378/chest.128.2.587.

  PMID: 16100142 BACKGROUND

• Janssens JP, Derivaz S, Breitenstein E, De Muralt B, Fitting JW, Chevrolet JC, Rochat T. Changing patterns in long-term noninvasive ventilation: a 7-year prospective study in the Geneva Lake area. Chest. 2003 Jan;123(1):67-79. doi: 10.1378/chest.123.1.67.

  PMID: 12527605 BACKGROUND

• Masa JF, Corral J, Alonso ML, Ordax E, Troncoso MF, Gonzalez M, Lopez-Martinez S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Aizpuru F, Egea C; Spanish Sleep Network. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. Pickwick Study. Am J Respir Crit Care Med. 2015 Jul 1;192(1):86-95. doi: 10.1164/rccm.201410-1900OC.

  PMID: 25915102 BACKGROUND

• Piper AJ, Wang D, Yee BJ, Barnes DJ, Grunstein RR. Randomised trial of CPAP vs bilevel support in the treatment of obesity hypoventilation syndrome without severe nocturnal desaturation. Thorax. 2008 May;63(5):395-401. doi: 10.1136/thx.2007.081315. Epub 2008 Jan 18.

  PMID: 18203817 BACKGROUND

• Borel JC, Tamisier R, Gonzalez-Bermejo J, Baguet JP, Monneret D, Arnol N, Roux-Lombard P, Wuyam B, Levy P, Pepin JL. Noninvasive ventilation in mild obesity hypoventilation syndrome: a randomized controlled trial. Chest. 2012 Mar;141(3):692-702. doi: 10.1378/chest.10-2531. Epub 2011 Sep 1.

  PMID: 21885724 BACKGROUND

• Berry RB, Chediak A, Brown LK, Finder J, Gozal D, Iber C, Kushida CA, Morgenthaler T, Rowley JA, Davidson-Ward SL; NPPV Titration Task Force of the American Academy of Sleep Medicine. Best clinical practices for the sleep center adjustment of noninvasive positive pressure ventilation (NPPV) in stable chronic alveolar hypoventilation syndromes. J Clin Sleep Med. 2010 Oct 15;6(5):491-509.

  PMID: 20957853 BACKGROUND

• Gonzalez-Bermejo J, Perrin C, Janssens JP, Pepin JL, Mroue G, Leger P, Langevin B, Rouault S, Rabec C, Rodenstein D; SomnoNIV Group. Proposal for a systematic analysis of polygraphy or polysomnography for identifying and scoring abnormal events occurring during non-invasive ventilation. Thorax. 2012 Jun;67(6):546-52. doi: 10.1136/thx.2010.142653. Epub 2010 Oct 22.

  PMID: 20971982 BACKGROUND

• Johnson KG, Johnson DC. Treatment of sleep-disordered breathing with positive airway pressure devices: technology update. Med Devices (Auckl). 2015 Oct 23;8:425-37. doi: 10.2147/MDER.S70062. eCollection 2015.

  PMID: 26604837 BACKGROUND

• Jaye J, Chatwin M, Dayer M, Morrell MJ, Simonds AK. Autotitrating versus standard noninvasive ventilation: a randomised crossover trial. Eur Respir J. 2009 Mar;33(3):566-71. doi: 10.1183/09031936.00065008.

  PMID: 19251798 BACKGROUND

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Obesity

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; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan F Masa, PhD

  Hospital San Pedro de Alcantara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Two investigators (named Investigator 1 and Investigator 2) participate in each center, with different tasks. Investigator 1 is responsible of randomization and will be aware of the study group assigned to the patient. Investigator 2 will collect in each visit health resource utilization, specific and QoL tests and laboratory test results. Investigator 2 does not know the study arm. Patients will not be informed about the ventilator settings and the menu of the ventilator will be locked, so they cannot access to ventilator data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, Randomized, double arm, double blind controlled trial.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: March 31, 2020
• Study Start: April 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 14, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)