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Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Cystic Fibrosis | Device: Nocturnal oxygen , nocturnal bi-level positive pressure ventilation | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Primary Purpose: Treatment |
| Official Title: | Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation |
- Quality of life questionnaires:
- CFQoL questionnaire (Gee,Thorax,2000)(a priori chest, physical function, treatment, emotion domains)
- Epworth Sleepiness Scale
- Pittsburgh Sleep Quality Index
- CF Subjective Symptoms Sleep disturbance Questionnaire (CSQ-in house)
- Medical Research Council Dyspnea Scale
- Baseline Dyspnea Index, Transitional Dyspnea Index
- Work or Study status
- Physiological:
- Nocturnal SpO2, nocturnal rise in transcutaneous CO2
- Daytime arterial blood gases (PaCO2, PaO2)
- Admission rate
- Lung function tests (FEV1, FVC, RV/ TLC)
- Modified CF shuttle walk test
- Neurocognitive testing (psychomotor vigilance task, Stroop, Controlled Oral Word Association Test, Trails A and B, digit recall forwards backwards)
- PSG (sleep efficiency, arousal index, % REM sleep, urinary catecholamines)
- Serum cytokines (IL-6, TNF alpha, IL-1 beta)
| Enrollment: | 59 |
| Study Start Date: | March 2003 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Cystic fibrosis is the commonest life-limiting genetic disorder in the Caucasian population with a median survival of 31 years. Lung disease is responsible for the majority of morbidity and mortality and correlates with declining quality of life. Respiratory failure is the primary cause of death. Daytime respiratory failure (hypoxia with pO2<55 and/or hypercapnia with pCO2>50) is associated with a worse prognosis with a 2-year survival of 50%. Nocturnal respiratory failure (greater than 5% of the night spent with SpO2<90% and/or rise in PtcCO2>10mmHg overnight) is a precursor to the development of daytime respiratory failure. It has been postulated that earlier treatment of respiratory failure may improve outcome and quality of life.
Intervention: Nocturnal O2 and bilevel NIPPV in CF patients with nocturnal respiratory failure, compared to nocturnal placebo (air). Crossover trial utilising patients as their own control.
Aims: (1) To assess the effects of non-invasive ventilation (NIV) and oxygen (O2) therapy on quality of life, hospital admission rate, sleep quality and exercise tolerance in CF patients with NRF (2) To identify a level of severity of NRF where treatment with NIV is effective
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
proven diagnosis cystic fibrosis, age 18 years or older, FEV1< 70% predicted normal, clinically stable (no admission or antibiotics last 2 weeks, OR end of admission where further clinical improvement not expected), nocturnal respiratory failure (SpO2<90% for > 10% of night or rise in PtcCO2 > 5 mmHg in REM), daytime hypercapnia (PaCO2> 45 mmHg)
Exclusion Criteria:
Previous home O2 or NIV use, Sedative medications, Cardiac/renal/endocrine/neurological disease likely to compromise ventilatory control
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00157183
| Australia, Victoria | |
| The Alfred | |
| Melbourne, Victoria, Australia, 3181 | |
| Principal Investigator: | Matthew T Naughton, MD | The Alfred |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bayside Health |
| ClinicalTrials.gov Identifier: | NCT00157183 History of Changes |
| Other Study ID Numbers: |
35/03 |
| Study First Received: | September 9, 2005 |
| Last Updated: | December 4, 2013 |
Keywords provided by Bayside Health:
|
cystic fibrosis hypoxia oxygen noninvasive ventilation quality of life |
Additional relevant MeSH terms:
|
Fibrosis Cystic Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on September 20, 2017