Optimisation of Mechanical Insufflation:Exsufflation

Status Recruiting

Clinical Trial Summary

Patients with neuromuscular diseases (NMD) can suffer from a range of respiratory problems due to respiratory muscle weakness. Cough muscle weakness means secretion clearance from the airways can be problematic, a source of infection, and importantly a cause of death, in this patient group. Therefore, these patients are often supported with devices to aid clearance, such as mechanical insufflation-exsufflation (MIE). Although evidence supports the use of these devices, the optimal technique or settings on the device are not clear. Increasingly, higher pressures are used during MIE and recent work has demonstrated that there may be a physiological benefit to this. However, higher pressures increase the risk of causing lung collapse and may cause detriment to blood flow back to the heart, which is important as NMD patients frequently have concurrent heart muscle weakness. Further, recent work has demonstrated that higher pressures can cause closure of the throat, which is counter-productive in secretion clearance. The overall aim of this study is to investigate methods to manipulate MIE to improve secretion clearance in patients with NMD. The questions it seeks to answer are: (i) how can we maximally improve lung recruitment during inspiration, whilst maintaining patient comfort and lower pressures (ii) what is the smallest pressure difference required in expiration to achieve an improvement in cough (iii) do these proposed changes to MIE also cause throat closure (iv) what factors do patients believe contribute to their adherence to MIE therapy? Patients with slowly progressive or stable neuromuscular diseases will be included in the study. Participation will involve two visits to the Lane Fox Respiratory Unit, each lasting approximately four hours. Patients will be recruited from specialist neuromuscular respiratory clinics by their clinical teams.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Neuromuscular Diseases

Clinical Trial Details

NCT number	NCT04163198
Study type	Interventional
Source	Guy's and St Thomas' NHS Foundation Trust
Contact	Patrick Murphy, PhD
Phone	+442071888070
Email	patrick.murphy@gstt.nhs.uk
Status	Recruiting
Phase	N/A
Start date	December 19, 2019
Completion date	May 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03548779` - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2	N/A
Completed	`NCT04435093` - Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
Not yet recruiting	`NCT04089696` - Validation of the "ExSpiron©" in Patients With ALS	N/A
Not yet recruiting	`NCT05785546` - Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System
Completed	`NCT01313325` - Hippotherapy to Improve the Balance of Children With Movement Disorders	N/A
Recruiting	`NCT04098094` - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Active, not recruiting	`NCT05070624` - The Peer Support Study	N/A
Completed	`NCT04729920` - Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases
Recruiting	`NCT04581577` - Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With Neuromuscular and Neurological Disorders
Completed	`NCT06428864` - Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
Enrolling by invitation	`NCT05539456` - Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old
Completed	`NCT05353738` - Efficacy of Vaccination Against COVID-19 in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy
Recruiting	`NCT04541602` - Detection of Neuromuscular Complications in Critically Ill Patients
Completed	`NCT03394859` - Electronic Medical Records and Genomics (eMERGE) Phase III
Enrolling by invitation	`NCT05099107` - Changes of Motor Function Tests in Congenital Myopathy Subjects Treated With Oral Salbutamol as Compared to no Treatment	N/A
Completed	`NCT05070910` - NDT Effectiveness Study	N/A
Recruiting	`NCT04100993` - Multisystem and Autonomic Complications of NMD on Long-term NIV
Recruiting	`NCT04986059` - Effects of Pre-event Massage on Muscle Activity	N/A
Completed	`NCT01022931` - Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva	N/A
Terminated	`NCT03353064` - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Optimisation of Mechanical Insufflation:Exsufflation — MIE2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms