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Patient Preference for Mouthpiece Ventilation

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ClinicalTrials.gov Identifier: NCT03867721
Recruitment Status : Completed
First Posted : March 8, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kristien Mostinckx, Revalidatieziekenhuis InkendaaI

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.


Condition or disease Intervention/treatment Phase
Neuromuscular Diseases Device: Ventilator Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: The Preference of Neuromuscular Patients Regarding Available Equipment for Daytime Mouthpiece Ventilation: a Randomized Cross-over Study
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ventilator PB560 (Covidien)
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
Comparison of two ventilators for mouthpiece ventilation

Experimental: Ventilator Trilogy (Philips Respironics)
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
Comparison of two ventilators for mouthpiece ventilation




Primary Outcome Measures :
  1. Transcutaneous Carbon dioxyde [ Time Frame: Day 2: continuous recording during trial 1 (30min) ]
    Maximal level of CO2 tension in blood (PCO2)

  2. Transcutaneous Carbon dioxyde [ Time Frame: Day 3: continuous recording during trial 2 (30min) ]
    Maximal level of CO2 tension in blood (PCO2)

  3. Trancutaneous Oxygen saturation [ Time Frame: Day 2: continuous recording during trial 1 (30min) ]
    Minimal level of Oxygen saturation (SpO2)

  4. Trancutaneous Oxygen saturation [ Time Frame: Day 3: continuous recording during trial 2 (30min) ]
    Minimal level of Oxygen saturation (SpO2)

  5. Borg dyspnea score [ Time Frame: Day 2: at the end of trial 1 ]
    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

  6. Borg dyspnea score [ Time Frame: Day 3: at the end of trial 2 ]
    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

  7. A 17-item questionnaire assessing the patient perception [ Time Frame: Day 2: at the end of trial 1 ]
    Score (0-5 points; 0: very bad ; 10: very good ) to evaluate the subjective perception (easiness-comfort) of patients with the ventilator equipment.

  8. A 17-item questionnaire assessing the patient perception [ Time Frame: Day 3: at the end of trial 2 ]
    Score (0-5 points; 0: very bad ; 10: very good ) to evaluate the subjective perception (easiness-comfort) of patients with the ventilator equipment.


Secondary Outcome Measures :
  1. Freetime [ Time Frame: On day 1 (baseline) ]
    Time of comfortable spontaneous breathing without assisted ventilation



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867721


Locations
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Belgium
Michel Toussaint
Vlezenbeek, Belgium, 1602
Sponsors and Collaborators
Revalidatieziekenhuis InkendaaI

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Responsible Party: Kristien Mostinckx, Head of Rehabilitation Department, Revalidatieziekenhuis InkendaaI
ClinicalTrials.gov Identifier: NCT03867721     History of Changes
Other Study ID Numbers: 2014-WMT-001
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristien Mostinckx, Revalidatieziekenhuis InkendaaI:
noninvasive ventilation
Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases