Mechanical Insufflator-exsufflator to Control Mucus Hypersecretion in Patients in Palliative Care - A Feasibility Study

NCT02651805 | Unknown

• 1 other identifier: MIE-Palliative
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with advanced chronic diseases may suffer with respiratory secretion and available therapies to control this condition are uncomfortable or little effective in palliative care patients. Therefore, alternative therapies should be tested, assessing clinically relevant outcomes in palliative care, such as comfort during therapy and the number of interventions required in a day. Mechanical Insufflation-Exsufflation is an option that presents advantages, since it can be used in patients with minimum cooperation and is non-invasive, which may lead to higher comfort during therapy. The aim of the study is to verify the feasibility of a clinical trial comparing the effects of Mechanical Insufflation-Exsufflation with usual care in hospitalized palliative care patients that are suffering with respiratory secretion. Patients allocation will follow a "fast-track allocation design", in which included patients will be randomized in two groups:

1. 1.Receive Mechanical Insufflation-Exsufflation therapy in the moment that is assigned to this group;
2. 2.will receive 24h of usual care and after that will be allowed to choose between usual care or Mechanical Insufflation-Exsufflation Therapy.

Conditions

Palliative Care; Mucus Hypersecretion

Keywords

Palliative Care; Respiratory Secretion

Outcome Measures

Primary Outcomes (1)

• Study Feasibility assessed by verifying the recruitment rates, acceptability of the patients and hospital

  The feasibility of the study will be the primary outcome, and it will be assessed by verifying the recruitment rates, acceptability of the patients and hospital, and if the assessments were suitable to the study

  Through the completion of the study, up to one year

Secondary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Assessed in the period between the start of the intervention until 30min after the end of the intervention

• Effect size of Palliative Outcome Scale

  Immediately after the inclusion and in the final assessment (24 hours after the inclusion).

• Effect size of discomfort due to the hypersecretion

  Immediately before the first intervention and ten minutes after the first intervention.

• Effect size of discomfort due to the therapy

  Ten minutes after the first intervention

• Effect size of time until the next intervention

  In the end of the 24 hours period.

Other Outcomes (1)

• Percentage of patients using pharmacological agents to control respiratory secretions

  In the completion of the study, an average of one year

Study Arms (2)

Mechanical Insufflation-Exsufflation Group

EXPERIMENTAL

Patients will receive usual care except suctioning or cough augmentation techniques+Mechanical Insufflation-Exsufflation

Device: Mechanical Insufflation-Exsufflation

Usual Care Group

ACTIVE COMPARATOR

Patients will receive the usual care provided by the hospital, all interventions to control respiratory secretion will be verified in patient chart

Device: Mechanical Insufflation-Exsufflation; Other: Usual Care

Interventions

Mechanical Insufflation-Exsufflation DEVICE

Mechanical Insufflator-Exsufflator (MI-E): 6 assisted cough with expiratory pressure of -40cmH2O and inspiratory pressure defined by the therapist as the maximum pressure defined as comfortable; inspiratory time 3s and expiratory time 4s, using a manual cycle. Patients will be instructed to cough during exsufflation phase, with exception of Chronic obstructive pulmonary disease patients which will be instructed to exhale slowly. An oral-nasal mask will be used as interface, but in patients with tracheotomy, the device will be connected to it. A trained physiotherapist will conduct the therapy. During the night and weekends, patients will not start this therapy, however, if they have already started the therapy in MI-E group, or if they have already finished the period of follow-up they will be able to request this therapy, which will be provided by hospital staff . The equipment (Cough Assist®, Respironics, Phillips), will be available in the ward for the interventions.

Also known as: Cough Assist (Philips Respironics)

Mechanical Insufflation-Exsufflation Group; Usual Care Group

Usual Care OTHER

The patients will receive the treatment according to the hospital protocol to deal with hypersecretive patients (suctioning that can be preceded by respiratory physiotherapy and nebulisation). A trained member of the nurse staff or a physiotherapist will be responsible for providing the therapy. A member of the research team will collect in the patients' records all the therapies provided by the staff to control hypersecretions.

Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prognosis:
• Less than one year assessed by the responsible physician, with a negative answer of the to the "surprise question" - Would you be surprised if this patient died in the following year?
• Higher than 3 months, assessed by the same physician
• Patients with problems to deal with secretions, which could be one or both of the following problems:
• Hypersecretion
• Cough inefficiency (peak cough flow \<250L/min)
• Karnofsky Performance Status Scale higher or equal to 30%;
• Ability to give written informed consent or presence of a person who is responsable for the patient

You may not qualify if:

• Patients with conditions considered as contra-indication for the use of Mechanical Insufflator-Exsufflator:
• Bullous emphysema history
• Known susceptibility for pneumothorax or pneumo-mediastinum
• Known to have had any recent barotrauma.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Hospital Estadual Américo Brasiliense: collaborator
• Philips Respironics: collaborator

Study Sites (1)

Hospital Estadual Américo Brasiliense

São Carlos, São Paulo, Brazil

RECRUITING

Related Publications (2)

• Bach JR. Mechanical insufflation-exsufflation. Comparison of peak expiratory flows with manually assisted and unassisted coughing techniques. Chest. 1993 Nov;104(5):1553-62. doi: 10.1378/chest.104.5.1553.

  PMID: 8222823 BACKGROUND

• Bach JR. Amyotrophic lateral sclerosis: prolongation of life by noninvasive respiratory AIDS. Chest. 2002 Jul;122(1):92-8. doi: 10.1378/chest.122.1.92.

  PMID: 12114343 BACKGROUND

Central Study Contacts

Juliano F Arcuri, MSc

CONTACT

+55 16 33518343; julianoarcuri@gmail.com

Valéria AP Di Lorenzo, PhD

CONTACT

+55 16 33518343; vallorenzo@ufscar.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: January 11, 2016
• Study Start: February 1, 2016
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

BR (1)