- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01380418
Factors Associated With Chronic Respiratory Failure in Obesity
Factors Associated With Chronic Respiratory Failure in Obesity: A Cross-sectional Study
Some overweight individuals develop problems with their breathing such that they gradually breathe less and less. This leads to a lack of oxygen and a buildup of carbon dioxide in the blood, called ventilatory failure. As a consequence, if such a person develops a chest infection, they are more likely to become seriously ill and need intensive care. In addition they are much more likely to develop severe complications during and following operations. This problem can be treated with a machine at home used overnight to help breathing. It is interesting that ventilatory failure only happens in some overweight individuals, and the investigators do not understand what factors make this complication develop. There are a number of theories: for example the distribution of the fat, additional lung disease (such as asthma), the addition of obstructive sleep apnoea, a condition when there are periods of cessation of breathing overnight (which is more common in obese individuals), weak muscles of breathing (perhaps due to fatty infiltration of muscles or vitamin D deficiency), and other hormonal changes.
The investigators intend to measure many potential factors in a range of overweight individuals, some who have ventilatory failure, and some who do not, to try and work out which are the important factors that cause this problem. If the investigators can identify such factors, then this will help predict in advance who is at risk from chest infections and during operations; thus allowing for earlier provision of an overnight breathing machine. This should reduce complications and potentially deaths in such individuals.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Oxford, Royaume-Uni, OX3 7LJ
- Oxford Radcliffe NHS Trust Hospitals
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Obese (BMI > 30kg/m2) with or without OHS (18-85yrs)
- Admitted for management of OHS
- Attending the sleep and ventilation clinic
- Being assessed for bariatric surgery
La description
Inclusion Criteria:
- Obese (BMI > 30) with or without obesity hypoventilation
- (OHS) (18 - 85yrs)
- Admitted for management of their OHS
- Attending the sleep and ventilation clinic
- Being assessed for bariatric surgery
- Willing and able to give informed consent for participation in the study
- Men and women aged 18 - 85 years
Exclusion Criteria:
- Respiratory acidosis pH <7.30
- Severe untreated hypothyroidism
- Current treatment with theophylline
- Current treatment with diuretics
- Severe restrictive or obstructive lung disease (<30% predicted)
- Severe comorbidities such as moderate/severe COPD, left sided heart failure, and primary CNS or neuromuscular diseases
- Contraindications to MRI scanning
- Contraindications to DXA scanning
- Previous participant in research in the last 12 months
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Study group
Obese BMI>30 18-85 years old
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To determine the physiological between obese patients with OHS and obese patients without OHS
Délai: 1 year
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This will be a detailed ventilatory drive measurements and muscle strength testing.
The comparison will be made within the group amongst the range of ventilatory failure
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1 year
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: John Stradling, FRCP MBBS PHD, University of Oxford
Publications et liens utiles
Publications générales
- Dattani RS, Swerner CB, Stradling JR, Manuel AR. Exploratory study into the effect of abdominal mass loading on airways resistance and ventilatory failure. BMJ Open Respir Res. 2016 Jun 9;3(1):e000138. doi: 10.1136/bmjresp-2016-000138. eCollection 2016.
- Manuel AR, Hart N, Stradling JR. Correlates of obesity-related chronic ventilatory failure. BMJ Open Respir Res. 2016 Feb 18;3(1):e000110. doi: 10.1136/bmjresp-2015-000110. eCollection 2016.
- Manuel ARG, Hart N, Stradling JR. Is a raised bicarbonate, without hypercapnia, part of the physiologic spectrum of obesity-related hypoventilation? Chest. 2015 Feb;147(2):362-368. doi: 10.1378/chest.14-1279.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Maladies des voies respiratoires
- Apnée
- Troubles respiratoires
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Troubles du sommeil et de l'éveil
- Suralimentation
- Troubles nutritionnels
- En surpoids
- Poids
- Signes et symptômes respiratoires
- Syndromes d'apnée du sommeil
- Apnée du sommeil, obstructive
- Obésité
- Insuffisance respiratoire
- Hypoventilation
- Syndrome d'obésité et d'hypoventilation
Autres numéros d'identification d'étude
- 11/H0605/9
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