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

April 9, 2009
February 9, 2012
April 2009
June 2012   (final data collection date for primary outcome measure)
Nocturnal Transcutaneous PCO2 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00879593 on ClinicalTrials.gov Archive Site
Pulmonary function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Nocturnal PtcCO2 Monitoring in Patients With Amyotrophic Lateral Sclerosis (ALS)
Potential Role for Nocturnal PtcCO2 Monitoring in the Close Follow up of ALS Patients.

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Amyotrophic Lateral Sclerosis
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.
Experimental: PtcCO2
Intervention: Device: PtcCO2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2013
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Thierry PEREZ, MD 03 20 44 56 19 TPEREZ@CHRU.LILLE.FR
France
 
NCT00879593
ANTADIR PTcCO2/SLA
No
Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Not Provided
Principal Investigator: Thierry PEREZ, MD CHRU LILLE
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP