Nocturnal PtcCO2 Monitoring in Patients With Amyotrophic Lateral Sclerosis (ALS)
Tracking Information | |||||
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First Received Date ICMJE | April 9, 2009 | ||||
Last Updated Date | February 9, 2012 | ||||
Start Date ICMJE | April 2009 | ||||
Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Nocturnal Transcutaneous PCO2 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00879593 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Pulmonary function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Nocturnal PtcCO2 Monitoring in Patients With Amyotrophic Lateral Sclerosis (ALS) | ||||
Official Title ICMJE | Potential Role for Nocturnal PtcCO2 Monitoring in the Close Follow up of ALS Patients. | ||||
Brief Summary | Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting motoneurons, with a prevalence around 5/100.000. Respiratory muscle involvement is a major feature in ALS and remains the main prognostic factor. Timing and rate of progression of this respiratory muscle involvement is also highly variable among individuals. Respiratory manifestations justify a careful follow up including clinical evaluation, pulmonary function tests and blood gases. Prognostic value of respiratory muscle assessment has been clearly demonstrated in ALS, although several cut off values have been published. The clinical benefit of non invasive ventilation (NIV) is well established in ALS, but the optimal criteria for its initiation remain debated . The 1999 consensus for NIV selected classical criteria to consider NIV in patients with respiratory symptoms suggesting hypoventilation: daytime hypercapnia (PaCO2 > 45 mmHg), nocturnal SaO2 < 89 % more than 5 consecutive minutes and for progressive neuromuscular disorders (NMD) (mainly ALS), a vital capacity (VC) < 50 % pred or a PImax < 60 cmH2O. Besides daytime clinical and PFT assessment, nocturnal evaluation is essential in ALS. The prevalence of sleep apnea ranges from 16 % to 76 %. Transcutaneous PCO2 (tcPCO2) is an attractive technique to evaluate non invasively nocturnal hypoventilation. The technique is well validated in different settings. Its use in neuromuscular disorders (NMD) is recent. In particular one study has demonstrated a high predictive value of tcPCO2 for the development of daytime hypoventilation within 1 year. To our knowledge, this technique has not been specifically assessed in ALS. There is a potential role for nocturnal PtcCO2 monitoring in the close follow up of ALS patients. Indeed, a close respiratory follow up of ALS patients is essential to determine the optimal timing of NIV, avoiding the occurence of unexpected acute respiratory failure. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Amyotrophic Lateral Sclerosis | ||||
Intervention ICMJE | Device: PtcCO2
Nocturnal assessment will be performed during the initial polysomnography (and at 6 months) with a combined PtcCO2/pulse oxymetry TOSCA500 Radiometer monitoring evaluating different physiological parameters. |
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Study Arm (s) | Experimental: PtcCO2
Intervention: Device: PtcCO2 |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 80 | ||||
Estimated Completion Date | June 2013 | ||||
Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | France | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00879593 | ||||
Other Study ID Numbers ICMJE | ANTADIR PTcCO2/SLA | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire | ||||
Study Sponsor ICMJE | Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire | ||||
Verification Date | February 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |