Chronic Hypercapnic Respiratory FailureTITRATIONNCT04327336
Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome
A study testing Manual Non invasive ventilation titration and Automatic Non invasive ventilation titration in people with Chronic Hypercapnic Respiratory Failure and Obesity Hypoventilation Syndrome, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome
- What is being tested?
- Manual Non invasive ventilation titration and Automatic Non invasive ventilation titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2020to 14 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Noninvasive Ventilation Adjusted Automatically in the Obesity Hypoventilation Syndrome
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.
Read the detailed description
Method: Prospective, blind researchers, randomized, controlled non-inferiority and cost-effectiveness relationship, with two parallel open groups. 200 OHS patients will be divided into two groups by simple randomization 1:1 and followed for one year. The premise of non-inferiority is -2 at the lower limit of the confidence interval 95% for the change in PCO2 between the arms being assessed by analysis of covariance, adjusted for 2-sided, age, sex, body mass index in intention-to-treat and per-protocol analysis. The cost-effectiveness will be performed by Bayesian techniques with sensitivity analysis.
- Being tested
- Manual Non invasive ventilation titration, Automatic Non invasive ventilation titration
- Keywords
- Chronic respiratory failure, Obesity, Non invasive mechanical ventilation
- Medical subject headings
- Obesity Hypoventilation Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Non invasive ventilation titrationDevice
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.
Automatic Non invasive ventilation titrationDevice
Automatic Group: the A40 ventilator in the automatic AVAPS mode will be adjusted in order to achieve 8-10 ml/kg of ideal weight.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Automatic Non invasive ventilation titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaCO2 between arms
Arterial blood gases while room air breathing expressed in mmHg
Measured: 1 year
Secondary outcomes (28)
Cost-effectiveness analysis by primary outcome
Cost-effectiveness analysis based on the primary outcome in mmHg Differences in within trial costs will be related with the differences in effectiveness (primary outcome) between arms using a probabilistic Bayesian approach to calculate the cost-effectiveness plane.
Measured: 1 year
Cost-effectiveness analysis by QALY
Cost-effectiveness analysis based on the quality adjusted life year (QALY) Differences in within trial costs will be related with the differences in effectiveness (QALY) between arms using a probabilistic Bayesian approach to calculate the cost-effectiveness plane.
Measured: 1 year
Change in subjective daytime sleepiness
Sleepiness evaluated by Epworth sleepiness scale, range from 0 to 24, being 0 the best result and 24 the worst.
Measured: 1 year
Change in Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ)
Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ), range from 0 to 120, being 0 the worst result and 120 the best result .
Measured: 1 year
Change in Quality of life measured by visual analogical wellbeing scale (VAWS)
Quality of life measured by visual analogical well-being scale (VAWS), range from 0 to 100, being 0 the worst result and 120 the best result .
Measured: 1 year
Change in Quality of life measured by Euroqol 5D.
Quality of life measured by Euroqol 5D, range from 0 to 1, being 0 the worst result and 1 the best result .
Measured: 1 year
Change in Quality of life measured by Short Form-36 (SF36), Mental component
Quality of life measured by Short Form-36 (SF36) Mental component,range from 0 to 100, being 0 the worst result and 100 the best result.
Measured: 1 year
Change in Quality of life measured by Short Form-36 (SF36), Physical component
Quality of life measured by Short Form-36 (SF36) Physical component,range from 0 to 100, being 0 the worst result and 100 the best result.
Measured: 1 year
Change in Bicarbonate arterial blood concentration
Arterial blood gases while breathing room air expressed in mmol/L
Measured: 1 year
Change in PaO2
Arterial blood gases while breathing room air expressed PaO2 in mmHg
Measured: 1 year
Change in pH
Arterial blood gases while breathing room air
Measured: 1 year
Change in polysomnographic Sleep periods
Standard polysomnography. time of sleep periods (Stage 1,2,3,4 and REM) in minutes.
Measured: 1 year
Change in Arousal Index
Standard polysomnography, number of arousals per sleep hour
Measured: 1 year
Change in Apnea-Hypopnea index
Standard polysomnography, number of apneas and hypoapneas per sleep hour
Measured: 1 year
Change in Oxygen desaturation index
Standard polysomnography, number of 3% or more Oxygen desaturations per sleep hour
Measured: 1 year
Change in Sleep time with Oxygen saturation below 90%
Standard polysomnography, percentage of sleep time with oxygen saturation below 90%
Measured: 1 year
Change in polysomnographic parameters: Total Sleep time (TTS)
Standard polysomnography, time in minutes
Measured: 1 year
Change in the blood pressure monitoring
The blood pressure will be monitored during 24 hours with a Blood Pressure Monitoring device before (baseline) and after intervention (1 year) in both arms measured in mmHg. Change in the mean blood pressure will be compared between arms
Measured: at baseline and after a year
Incidental cardiovascular events
New hypertension diagnosis or anti-hypertensive treatment, atrial fibrillation, hospitalization for nonfatal myocardial infarction or instable angina, nonfatal stroke or transient ischemic attack or for heart failure episode, and cardiovascular death. Data obtained from official electronic health care databases
Measured: 1 year
Health care resources utilization: Hospital admission
Hospital admission measured in number of events
Measured: 1 year
Health care resources utilization: Hospital duration
Hospital duration measured in days of hospitalization
Measured: 1 year
Health care resources utilization: ICU admission
ICU admission measured in numbers of events
Measured: 1 year
Health care resources utilization: ICU duration
ICU duration measured in days of UCI admissions
Measured: 1 year
Health care resources utilization: emergency visits
Emergency visits measured in number of events
Measured: 1 year
Health care resources utilization: primary care visits
Primary care visits measured in number of events
Measured: 1 year
Health care resources utilization: specialist visits
Specialist visits measured in number of events
Measured: 1 year
Incidence of new adverse event
Number of adverse events based in CTCAE v4.0
Measured: 1 year
Side effects
Incidence or side effects of NIV in follow-up visits: excessive noise, headache, claustrophobia, difficulty in sleep conciliation or maintenance, expiration discomfort.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Apr 2020
- Primary completion1 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, double arm, double blind controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Juan F Masa, PhD, Principal investigator, Hospital San Pedro de Alcantara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327336
- Sponsor's protocol ID
- PI16/01704
- Acronym
- TITRATION
- Status last verified
- Nov 2023
- First submitted
- 15 May 2018
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18250215Nowbar 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.
PubMed 14706658Berg 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.
PubMed 11502632Lopez-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.
PubMed 26656679Masa 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.
PubMed 11296176Perez 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.
PubMed 16100142Janssens 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.
PubMed 12527605Masa 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.
PubMed 25915102Piper 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.
PubMed 18203817Borel 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.
PubMed 21885724Berry 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.
PubMed 20957853Gonzalez-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.
PubMed 20971982Johnson 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.
PubMed 26604837Jaye 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.
PubMed 19251798Sanchez-Quiroga MA, Benitez I, Mokhlesi B, Gomez de Terreros FJ, Roncero A, Ruiz-Martinez C, Breton M, Troncoso MF, Herrero J, Lopez-Martin S, Lopez-Padilla D, Gonzalez M, Diaz de Teran T, Caballero-Eraso C, Marti S, Penacoba P, Galdeano M, Munoz-Mendez J, Barca J, Barbe F, Utrabo I, Duran JA, Masa JF; Spanish Sleep Network. Effectiveness of automatically-adjusted vs manually-adjusted noninvasive ventilation in obesity hypoventilation syndrome: a randomized clinical trial. Am J Respir Crit Care Med. 2026 May 1;212(5):989-1004. doi: 10.1093/ajrccm/aamag018.
PubMed 41738216
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Noninvasive Ventilation Adjusted Automatically in the Obesity Hypoventilation Syndrome
- ClinicalTrials.gov ID
- NCT04327336
- Acronym / sponsor ID
- TITRATION / PI16/01704
- Keywords
- Chronic respiratory failure, Obesity, Non invasive mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Method: Prospective, blind researchers, randomized, controlled non-inferiority and cost-effectiveness relationship, with two parallel open groups. 200 OHS patients will be divided into two groups by simple randomization 1:1 and followed for one year. The premise of non-inferiority is -2 at the lower limit of the confidence interval 95% for the change in PCO2 between the arms being assessed by analysis of covariance, adjusted for 2-sided, age, sex, body mass index in intention-to-treat and per-protocol analysis. The cost-effectiveness will be performed by Bayesian techniques with sensitivity analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, Randomized, double arm, double blind controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Manual | Active comparator | Device: Manual Non invasive ventilation titrationIn 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. |
| Automatic | Active comparator | Device: Automatic Non invasive ventilation titrationIn this group the ventilator will run in an automatic mode (AVAPS) with the same Phillips A40 ventilator. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Non invasive ventilation titrationManual 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. | Device | Manual |
| Automatic Non invasive ventilation titrationAutomatic Group: the A40 ventilator in the automatic AVAPS mode will be adjusted in order to achieve 8-10 ml/kg of ideal weight. | Device | Automatic |
Primary outcome
Change in PaCO2 between arms
Time frame: 1 year
Arterial blood gases while room air breathing expressed in mmHg
28 secondary outcomes
Cost-effectiveness analysis by primary outcome
Time frame: 1 year
Cost-effectiveness analysis by QALY
Time frame: 1 year
Change in subjective daytime sleepiness
Time frame: 1 year
Change in Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 1 year
Change in Quality of life measured by visual analogical wellbeing scale (VAWS)
Time frame: 1 year
Change in Quality of life measured by Euroqol 5D.
Time frame: 1 year
Change in Quality of life measured by Short Form-36 (SF36), Mental component
Time frame: 1 year
Change in Quality of life measured by Short Form-36 (SF36), Physical component
Time frame: 1 year
Change in Bicarbonate arterial blood concentration
Time frame: 1 year
Change in PaO2
Time frame: 1 year
Change in pH
Time frame: 1 year
Change in polysomnographic Sleep periods
Time frame: 1 year
Change in Arousal Index
Time frame: 1 year
Change in Apnea-Hypopnea index
Time frame: 1 year
Change in Oxygen desaturation index
Time frame: 1 year
Change in Sleep time with Oxygen saturation below 90%
Time frame: 1 year
Change in polysomnographic parameters: Total Sleep time (TTS)
Time frame: 1 year
Change in the blood pressure monitoring
Time frame: at baseline and after a year
Incidental cardiovascular events
Time frame: 1 year
Health care resources utilization: Hospital admission
Time frame: 1 year
Health care resources utilization: Hospital duration
Time frame: 1 year
Health care resources utilization: ICU admission
Time frame: 1 year
Health care resources utilization: ICU duration
Time frame: 1 year
Health care resources utilization: emergency visits
Time frame: 1 year
Health care resources utilization: primary care visits
Time frame: 1 year
Health care resources utilization: specialist visits
Time frame: 1 year
Incidence of new adverse event
Time frame: 1 year
Side effects
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 18250215Mokhlesi 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.
- Background: PubMed 14706658Nowbar 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.
- Background: PubMed 11502632Berg 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.
- Background: PubMed 26656679Lopez-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.
- Background: PubMed 11296176Masa 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.
- Background: PubMed 16100142Perez 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.
- Background: PubMed 12527605Janssens 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.
- Background: PubMed 25915102Masa 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.
- Background: PubMed 18203817Piper 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.
- Background: PubMed 21885724Borel 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.
- Background: PubMed 20957853Berry 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.
- Background: PubMed 20971982Gonzalez-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.
- Individual participant dataSharing planned: No
Related trials for Chronic Hypercapnic Respiratory Failure
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingObservational study
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia
Recruiting
HFNC Versus NIV in Hypercapneic COPD Patients
COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Recruiting
Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Hypercapnic Acidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan F Masa, PhD principal investigator
Hospital San Pedro de Alcantara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Non invasive ventilation titration and Automatic Non invasive ventilation titration in people with Chronic Hypercapnic Respiratory Failure and Obesity Hypoventilation Syndrome, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PaCO2 between arms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327336, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.