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

NCT ID: NCT00613899

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-10-31

Brief Summary

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

Detailed 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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telesurveillance

At time of discharge from hospital, 40 ALS patients willbe enrolled in a telesurveillance program (TP) for the management of cought at home.

Two hours of an in-hospital educational training will be provided to patients and caregivers on the use of:

1. air stacking with Ambu balloon

2. manual manoeuvres and

3. in-Exoflator device indications and use

Group Type: OTHER

telesurveillance

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

telemedicine

Eligibility Criteria

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

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Salvatore Maugeri

OTHER

Sponsor Role: lead

Responsible Party

Michele Vitacca

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

michele vitacca, MD

Role: STUDY_CHAIR

FSM IRCCS Lumezzane

michele vitacca, MD

Role: PRINCIPAL_INVESTIGATOR

FSM IRCCS LUmezzane (BS) ITALY

Locations

Michele Vitacca

Lumezzane, BS, Italy

Countries

Italy

References

Sancho J, Servera E, Diaz J, Marin J. Efficacy of mechanical insufflation-exsufflation in medically stable patients with amyotrophic lateral sclerosis. Chest. 2004 Apr;125(4):1400-5. doi: 10.1378/chest.125.4.1400.

Reference Type: BACKGROUND

PMID: 15078752 (View on PubMed)

Vitacca M, Paneroni M, Trainini D, Bianchi L, Assoni G, Saleri M, Gile S, Winck JC, Goncalves 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: 10.1097/PHM.0b013e3181d89760.

Reference Type: RESULT

PMID: 20407305 (View on PubMed)

Paneroni M, Trainini D, Winck JC, Vitacca M. Pilot study for home monitoring of cough capacity in amyotrophic lateral sclerosis: A case series. Rev Port Pneumol. 2014 Jul-Aug;20(4):181-7. doi: 10.1016/j.rppneu.2013.11.003. Epub 2014 Feb 1.

Reference Type: DERIVED

PMID: 24491372 (View on PubMed)

Related Links

http://www.aisla.it

association of amyotrophic lateral sclerosis patients

Other Identifiers

N°83_researchbookFSM2006

Identifier Type: -

Identifier Source: org_study_id