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

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ClinicalTrials.gov Identifier: NCT00879593
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: PtcCO2 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Potential Role for Nocturnal PtcCO2 Monitoring in the Close Follow up of ALS Patients.
Study Start Date : April 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : January 2017


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Nocturnal Transcutaneous PCO2 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pulmonary function [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879593


Locations
France
PEREZ
Lille, France, 59037
Pôle des maladies respiratoires et service EFR- Centre hospitalier Regional Universitaire
Lille, France
Sponsors and Collaborators
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Investigators
Principal Investigator: Thierry PEREZ, MD CHRU LILLE

Responsible Party: DELRIEU Jacqueline, PhD, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
ClinicalTrials.gov Identifier: NCT00879593     History of Changes
Other Study ID Numbers: ANTADIR PTcCO2/SLA
First Posted: April 10, 2009    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

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