Patient Preference for Mouthpiece Ventilation

NCT03867721 | Completed

• 1 other identifier: 2014-WMT-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Patients with severe neuromuscular disorders (NMDs) are likely to develop progressive respiratory insufficiency, leading to noninvasive ventilation during the night and, later, during night and day. Ventilation via a mouthpiece (MPV) is an elegant option to offer daytime ventilation. The patient preference regarding the ideal material for daytime MPV is unclear. OBJECTIVES: The purpose of this study was to determine which ventilator, tubing support and mouthpiece was most effective and preferred by patients with NMDs. METHODS: Two separate MPV equipment sets were compared in 20 patients with NMDs in a randomized cross-over study. The first set consisted in a non-dedicated ventilator for MPV (PB560, Covidien) combined with a customized tubing support on the shoulders and a plastic angled mouthpiece. The second set included an MPV-dedicated ventilator (Trilogy 100, Philips Respironics) without back-up rate and kiss trigger combined with a commercially available tubing support and a silicone straw mouthpiece. The Borg dyspnea score, the free time without noninvasive ventilation, the transcutaneous oxygen saturation (SpO2) and carbon dioxide tension (TcCO2) were recorded without and with MPV. A 17-items list assessing the patient perception about MPV sets was completed.

Conditions

Neuromuscular Diseases

Keywords

noninvasive ventilation

Outcome Measures

Primary Outcomes (8)

• Transcutaneous Carbon dioxyde

  Maximal level of CO2 tension in blood (PCO2)

  Day 2: continuous recording during trial 1 (30min)

• Transcutaneous Carbon dioxyde

  Maximal level of CO2 tension in blood (PCO2)

  Day 3: continuous recording during trial 2 (30min)

• Trancutaneous Oxygen saturation

  Minimal level of Oxygen saturation (SpO2)

  Day 2: continuous recording during trial 1 (30min)

• Trancutaneous Oxygen saturation

  Minimal level of Oxygen saturation (SpO2)

  Day 3: continuous recording during trial 2 (30min)

• Borg dyspnea score

  Score (0-10 points; 0: very comfortable; 10: very uncomfortable) to evaluate the subjective feeling of breathing comfort. Borg is not an abbreviation but it is name of the author who validated the score. Dyspnea score is named "Borg" visual analogic score

  Day 2: at the end of trial 1

• Borg dyspnea score

  Score (0-10 points; 0: very comfortable; 10: very uncomfortable) to evaluate the subjective feeling of breathing comfort. Borg is not an abbreviation but it is name of the author who validated the score. Dyspnea score is named "Borg" visual analogic score

  Day 3: at the end of trial 2

• A 17-item questionnaire assessing the patient perception

  Score (0-5 points; 0: very bad ; 10: very good ) to evaluate the subjective perception (easiness-comfort) of patients with the ventilator equipment.

  Day 2: at the end of trial 1

• A 17-item questionnaire assessing the patient perception

  Score (0-5 points; 0: very bad ; 10: very good ) to evaluate the subjective perception (easiness-comfort) of patients with the ventilator equipment.

  Day 3: at the end of trial 2

Secondary Outcomes (1)

• Freetime

  On day 1 (baseline)

Study Arms (2)

Ventilator PB560 (Covidien)

EXPERIMENTAL

The non-dedicated (NON-DED) set comprised a ventilator for MPV (PB560) using a single active tubing with an exhalation valve. A custom-made arm support and plastic mouthpiece were used.

Device: Ventilator

Ventilator Trilogy (Philips Respironics)

EXPERIMENTAL

The dedicated (DED) set comprised a ventilator for MPV (Trilogy 100, Philips Respironics; with dedicated software, with a single passive tubing without exhalation valve. A back-up rate set at zero cycle per minute was associated with a kiss trigger, with a smart flexible tube support system and with a silicone made mouthpiece designed as a straw.

Device: Ventilator

Interventions

Ventilator DEVICE

Comparison of two ventilators for mouthpiece ventilation

Ventilator PB560 (Covidien); Ventilator Trilogy (Philips Respironics)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All individuals affected by NMDs attending our Centre for Home Mechanical Ventilation between January 2015 and December 2018 who required daytime MPV as an extension of nocturnal NIV

You may not qualify if:

• Patients with no need for daytime ventilation
• patients with ineffective NIV during sleep as assessed by the measurement of TcCO2\>49mmHg (S)
• patients with uncontrollable oral leaks with MPV or episode of acute respiratory infection during the trials

Sponsors & Collaborators

• Revalidatieziekenhuis InkendaaI: lead

Study Sites (1)

Michel Toussaint

Vlezenbeek, 1602, Belgium

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Department

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 8, 2019
• Study Start: January 1, 2015
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)