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

NCT ID: NCT02651805

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-07-30

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. Receive Mechanical Insufflation-Exsufflation therapy in the moment that is assigned to this group;

2. will receive 24h of usual care and after that will be allowed to choose between usual care or Mechanical Insufflation-Exsufflation Therapy.

The assessments will be: Time from the first intervention until the need of a following intervention, discomfort due therapy, discomfort due respiratory secretion, palliative outcome scale, number of adverse events and number of interventions during 24h period. The primary outcome is to verify the feasibility of developing a future larger clinical trial to assess the effects of the use of Mechanical Insufflation-Exsufflation to control respiratory secretions in patients in palliative care.

Detailed Description

Investigators will conduct a feasibility study for a future fast track randomized trial, which will be carried out in the Américo Brasiliense State Hospital and conducted by the Spirometry and Respiratory Physiotherapy Laboratory from the Federal University of São Carlos, Brazil.

The concept of feasibility is defined as "capable of being done or carried out" and studies which aim is to verify the feasibility intends to verify if a larger clinical trial would have a acceptable probability of success in proving the efficacy of an intervention 24. The importance of feasibility studies has been discussed since health research resources are frequently wasted in large clinical trials with interventions with small impact, studies with insufficient power, or even using measures and outcomes that do not reflect the expected changes caused by the interventions. Furthermore, these studies are essential when dealing with populations that usually lead to an increased chance of losing the follow-up or a high number of missing data, such as palliative care.

Both groups will receive the therapy with the mechanical insufflators-exsufflator, however, the Mechanical insufflation-exsufflation group will receive it as in a fast track way, while the usual care, will receive the usual care for more 24 hours, and then they will receive one session of Mechanical Insufflation-Exsufflation. After this 24 hours period, the patients will be asked what therapy they would like to receive each time they need help to deal with hypersecretion until the end of the hospitalization, or until the physician responsible for the patient consider the hypersecretion was controlled.

The allocation through fast track has been used due to ethical reasons, in order to maintain the randomized and controlled aspects of the research, and yet provide the opportunity to all patients to be benefited of the new intervention before the end of the study. Furthermore, an increase in the acceptability and retention of the participants is expected, since they are going to receive the new therapy in some moment of the study, which may be during or after the follow-up 28. The cross-over design was not chosen, since the wash-out period necessary to this model of study might lead to a period without treatment for vulnerable patients, with expected short life time.

Usual Care 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.

Mechanical Insufflation-Exsufflation The settings used in the Mechanical Insufflator-Exsufflator will be the same of a previous study, where were used: six assisted cough cycles with pressures of 40 to -40cmH2O; the inspiratory time of 3s; the expiratory time 4s and a pause between cycles of 4s. The patients will be instructed to cough alongside the 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.

Conditions

Palliative Care; Mucus Hypersecretion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mechanical Insufflation-Exsufflation Group

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

Group Type: EXPERIMENTAL

Mechanical Insufflation-Exsufflation

Intervention Type: 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.

Usual Care Group

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

Group Type: ACTIVE_COMPARATOR

Mechanical Insufflation-Exsufflation

Intervention Type: 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.

Usual Care

Intervention Type: 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.

Interventions

Mechanical Insufflation-Exsufflation

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.

Intervention Type: DEVICE

Usual Care

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.

Intervention Type: OTHER

Other Intervention Names

Cough Assist (Philips Respironics)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

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

Sponsors

Hospital Estadual Américo Brasiliense

UNKNOWN

Sponsor Role: collaborator

Philips Respironics

INDUSTRY

Sponsor Role: collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Juliano Ferreira Arcuri

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Estadual Américo Brasiliense

São Carlos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Juliano F Arcuri, MSc

Role: CONTACT

julianoarcuri@gmail.com

+55 16 33518343

Valéria AP Di Lorenzo, PhD

Role: CONTACT

vallorenzo@ufscar.br

+55 16 33518343

Facility Contacts

Juliano F Arcuri, MSc

Role: primary

julianoarcuri@gmail.com

+55 16 33518343

References

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.

Reference Type: BACKGROUND

PMID: 8222823 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12114343 (View on PubMed)

Other Identifiers

MIE-Palliative

Identifier Type: -

Identifier Source: org_study_id