Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613899
• Other study ID #: N°83_researchbookFSM2006
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2008
• Last updated: February 3, 2016
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: July 2011
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients.

Description:

Background: Amyotrophic Lateral Sclerosis (ALS) patients present reduction in the inspiratory and expiratory muscle strength, frequent secretions increase, insufficient expectoration ability with inevitable risk of acute respiratory failure (ARF) and necessity of hospitalizations. Recently, new mechanical tools (In-Exoflator EmersonR) are available in our hospital to help patients to expectorate during ARF. It is well noted these patients are particularly reluctant to be hospitalized to avoid further worsening in their quality of life.

Aim: the investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients.

Methods: A telesurveillance program (TP), a pulsed saturimetric device, 2 hours educational hospital sections (air stacking with Ambu balloon, manual manoeuvres and In-Exoflator indications and use) will be offered to all ALS consecutive patients.

In details the TP is structured as follows: 1) Domiciliary Telesurveillance by only one 24-h Service Centre (SC) for enrolled pts with ALS in hospital discharge phase, 2) Patients - taken care of five days/week by a nurse-tutor (NT) and respiratory therapist (RT) according to a predefined appointments, 3) for 24-hr. duration (in case of symptoms) patients can call SC and talk to pneumologists that can intervene whenever needed for diagnostic-therapeutic adjustments. 4) In case of need the patient can contact the neurologist or psychologist; 5) The RT in accordance with pneumologist can decide for a domiciliary visit to patient.

Home RT accesses and In-Exoflator activation will be prescribed when patients will present worsening of three points in pSaTO2, 30% in peak cough expiratory flow (PCEF), lack of cough ability with increase in secretions and or suctions necessity (in tracheotomy patients) and clinical symptoms (dyspnoea, fever, headache, somnolence).

Number of In-Ex and air stacking activations, ARF episodes, hospital accesses, antibiotic therapy, customer satisfaction, PCF/PEF, MIC-VC, respiratory function (MIP, MEP, FEV1, FVC, FEV1/FVC, ABG), dyspnoea (Borg scale), general disability (Hoevelaken scale and ALS Functional Rating Scale) and survival will be collected.

Expected results: 30 ALS patients (VC < 80% and 40% with tracheotomy) will be enrolled after discharge from Respiratory or Neurological units of S. Maugeri Foundation. This study will allow:

1. To test a possible alternative of care for ALS patients

2. To check patients and caregivers' acceptance

3. To measure time consuming for care team

4. To quantify patient's comfort

5. To test costs/effectiveness ratio.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

• 40 ALS patients (VC < 80% with or without tracheostomy)will be enrolled after discharge from Respiratory or Neurological units of S. Maugeri Foundation.

Exclusion Criteria:

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis

Intervention

Other:
• telesurveillance
A telesurveillance program for cough assistance will be approched by the use of an in-exoflator device. Measurement of oxygen saturation (SpO2) will be performed by a Nonin 9500 oxymeter (Minneapolis Plymouth USA).

Locations

Country	Name	City	State
Italy	Michele Vitacca	Lumezzane	BS

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Sancho J, Servera E, Díaz J, Marín J. Efficacy of mechanical insufflation-exsufflation in medically stable patients with amyotrophic lateral sclerosis. Chest. 2004 Apr;125(4):1400-5. — View Citation

Vitacca M, Paneroni M, Trainini D, Bianchi L, Assoni G, Saleri M, Gilè S, Winck JC, Gonçalves MR. At home and on demand mechanical cough assistance program for patients with amyotrophic lateral sclerosis. Am J Phys Med Rehabil. 2010 May;89(5):401-6. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test a possible alternative of care for ALS patients (home vs hospital)		6-12 months	Yes
Secondary	To check patients and caregivers' acceptance		6-12 months	No

External Links

•   association of amyotrophic lateral sclerosis patients