Clinical trial NCT02651805: Mechanical Insufflator-exsufflator to Control Mucus Hypersecretion in Patients in Palliative Care - A Feasibility Study
Official title: Mechanical Insufflator-exsufflator to Manage Respiratory Secretion in Patients in Palliative Care - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Mucus Hypersecretion
Keywords: Palliative Care
Respiratory Secretion
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Hospital Estadual Américo Brasiliense
name: Philips Respironics
First posted: 2016-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Study Feasibility assessed by verifying the recruitment rates, acceptability of the patients and hospital
timeFrame: Through the completion of the study, up to one year
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Assessed in the period between the start of the intervention until 30min after the end of the intervention
measure: Effect size of Palliative Outcome Scale
timeFrame: Immediately after the inclusion and in the final assessment (24 hours after the inclusion).
measure: Effect size of discomfort due to the hypersecretion
timeFrame: Immediately before the first intervention and ten minutes after the first intervention.
measure: Effect size of discomfort due to the therapy
timeFrame: Ten minutes after the first intervention
measure: Effect size of time until the next intervention
timeFrame: In the end of the 24 hours period.
measure: Effect size of number of interventions during 24 hours
timeFrame: In the end of the 24 hours period
Other outcomes:
measure: Percentage of patients using pharmacological agents to control respiratory secretions
timeFrame: In the completion of the study, an average of one year
Locations:
city: São Carlos
country: Brazil
facility: Hospital Estadual Américo Brasiliense
state: São Paulo
Study officials:
References:
citation: 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.
citation: 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.