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Nocturnal PtcCO2 Monitoring in Patients With Amyotrophic Lateral Sclerosis (ALS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:
NCT00879593
First received: April 9, 2009
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Amyotrophic Lateral Sclerosis
Device: PtcCO2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Potential Role for Nocturnal PtcCO2 Monitoring in the Close Follow up of ALS Patients.

Resource links provided by NLM:


Further study details as provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

Primary Outcome Measures:
  • Nocturnal Transcutaneous PCO2 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pulmonary function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PtcCO2 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Amyotrophic lateral sclerosis :definite, probable or probable with EMG (Airlie House Criteria, 1998).
  • Forced vital capacity >70% pred.
  • Daytime PaCO2 <43 mmHg.
  • Venous HCO3- <28 mmol/L

Exclusion Criteria:

  • Patients unable to perform pulmonary function tests or nocturnal recordings.
  • Coexisting significant lung disease: moderate to severe asthma or COPD
  • Current NIV, CPAP or oxygen therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879593

Contacts
Contact: Thierry PEREZ, MD 03 20 44 56 19 TPEREZ@CHRU.LILLE.FR

Locations
France
PEREZ Recruiting
Lille, France, 59037
Contact: Thierry PEREZ    +33.3.20.44.56.19      
Pôle des maladies respiratoires et service EFR- Centre hospitalier Regional Universitaire Recruiting
Lille, France
Contact: Thierry PEREZ, MD- PhD    03 20 44 56 19    TPEREZ@CHRU-LILLE.FR   
Principal Investigator: Thierry PEREZ, MD         
Sponsors and Collaborators
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Investigators
Principal Investigator: Thierry PEREZ, MD CHRU LILLE
  More Information

No publications provided

Responsible Party: Daniel VEALE, Doctor (co-investigator), Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier: NCT00879593     History of Changes
Other Study ID Numbers: ANTADIR PTcCO2/SLA
Study First Received: April 9, 2009
Last Updated: February 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on November 24, 2014