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Inspiratory Muscle Training and Nasal High Flow in Difficult Weaning

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ClinicalTrials.gov Identifier: NCT03908658
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
ISCHAKI ELENI, Evangelismos Hospital

Brief Summary:
The purpose of the present study is to investigate the effectiveness of inspiratory muscle training and nasal high flow oxygen in patients with difficult weaning and high-risk for re-intubation. The hypothesis of the study is that starting inspiratory muscle training once patients are awake and co-operative along with the application of nasal high flow oxygen immediately after extubation will have a beneficial effect in preventive re-intubation in these high-risk patients.

Condition or disease Intervention/treatment Phase
High-risk for Reintubation Patients Weaning Outcome Other: Inspiratory muscle Training and Nasal High Flow Device: Inspiratory muscle training and Venturi mask Not Applicable

Detailed Description:

20-30% of intubated patients are difficult to be weaned off the mechanical ventilation and have a prolonged ICU stay. It is well established that prolonged ICU stay is associated with reduced muscle strength, functional ability and quality of life.

Inspiratory muscle training (IMT) via a threshold device has been proposed as an effective exercise for minimizing the detrimental effect of mechanical ventilation in critical ill patients with prolonged weaning. Additionally, Nasal High Flow (NHF) oxygen has been proved to support efficiently either high or low-risk patients after extubation and thus preventing re-intubation.

A randomized intervention study was designed to assess the efficacy of combining IMT and NHF as therapeutic strategies for difficult weaning. Once patients with prognostic factors of difficult weaning are awake and co-operative they will be randomized to one of the two following study groups: 1) IMT and NHF group, 2) IMT and Venturi mask group. IMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Each allocated oxygen delivery device will be applied immediately after extubation. IMT intervention will continue until patients' discharge from the ICU.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effectiveness of Inspiratory Muscle Training and Nasal High Flow Oxygen in Difficult Weaning of ICU Patients
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : March 20, 2021

Arm Intervention/treatment
Active Comparator: Inspiratory Muscle Training and Nasal High Flow
Inspiratory Muscle Training will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Nasal High Flow will be applied immediately after extubation. IMT intervention will continue until patient's discharge from the ICU
Other: Inspiratory muscle Training and Nasal High Flow
Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Nasal High Flow will support respiratory muscles and thus reduce the work of breathing. By this mechanism the endurance of the respiratory muscles will increase in parallel with the strenght

Active Comparator: Inspiratory Muscle Training and Venturi mask
IMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Venturi mask will be applied immediately after extubation. IMT intervention will continue until patient's discharge from the ICU
Device: Inspiratory muscle training and Venturi mask
Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Venturi mask is usually applied after extubation in every day clinical practice for oxygen supplementation




Primary Outcome Measures :
  1. Rate of weaning failure [ Time Frame: 48 hours after extubation ]
    Rate of weaning failure in high-risk for reintubation patients


Secondary Outcome Measures :
  1. Maximal Inspiratory Pressure [ Time Frame: Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge ]
    Maximal Inspiratory Pressure (MIP) will be assessed witn an unidirectional expiratory valve which permit exhalation while inspiration is blocked. One side of the valve will be attached to the patient's endotracheal tube and the other side to a manometer. Manometer could register pressures from 0 to 60 cmH20. Patients will be disconnected from the ventilator and attached to the valve for a period of more than 30 sec. The most negative value will be recorded

  2. Maximal Expiratory Pressure [ Time Frame: Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge ]
    Maximal Expiratory Pressure (MEP) will be assessed witn an unidirectional inspiratory valve which permit inspiration while expiration is blocked. One side of the valve will be attached to the patient's endotracheal tube and the other side to a manometer. Manometer could register pressures from 0 to 60 cmH20. Patients will be disconnected from the ventilator and attached to the valve for a period of more than 30 sec. The highest value will be recorded

  3. Endurance of respiratory muscles [ Time Frame: Within 2 hours after patient randomization, within 24 hours after extubation , within 24 hours after ICU discharge ]
    Endurance of respiratory muscles will be calculated comparing the preloading and postloading values of the MIP

  4. Muscle strenght [ Time Frame: Within 2 hours after patient randomization, within 24 hours after ICU discharge, within 24 hours before hospital discharge ]
    Muscle strength will be assessed by the sum of Medical Research Council (MRC) scale for muscle strength in 6 different muscle groups ( shoulder abductors, forearm flexors, wrist flexors, hip flexors, knee extensors and plantar dorsiflexors) for both body sides. Each muscle group scores from 0 (no contraction) up to 5 (movement against gravity) and the total score range from 0 (worse outcome) up to 60 (best outcome)

  5. Functional ability [ Time Frame: Within 24 hours after ICU discharge, within 24 hours before hospital discharge ]
    Functional ability will be assessed by Functional Independence Measure (FIM) which includes 18 questions (13 motor tasks and 5 cognitive tasks). Each item is scored on a 7 point ordinal scale, ranging from a score of 1 (total inability-dependence) to a score of 7 (total independence). The higher the score, the more independent the patient is in performing the task associated with that item.The total score for the FIM motor subscale (the sum of the individual motor subscale items) will be a value between 13 and 91. The total score for the FIM cognition subscale (the sum of the individual cognition subscale items) will be a value between 5 and 35. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 (total dependency) and 126 total indepedency

  6. Short Form 36 Health Survey (SF-36) questionnaire [ Time Frame: Within 24 hours before hospital discharge ]
    Quality of life (QoL) will be assessed by Short Form 36 Health Survey (SF-36) which includes 36 items to measure 8 QoL domains. More specifically, from SF-36 only the domains parts of Physical Functioning (PF) which includes 10 questions with possible scores from 1 to 3, the Role Physical (RF) which includes 4 yes or no questions, the Social Functioning (SF) which includes 2 questions with possible scores form 1 to 5 and the Mental Health domain (MH) which includes 9 questions with possible scores form 1 to 9 will be used. Regarding the scoring of the questions 1 is the worst outcome. Each domain is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  7. Euro-Qol 5 Dimensions 5 Level of severity scale (Euro-Qol 5D-5L scale) [ Time Frame: Within 24 hours before hospital discharge ]
    Euro-Qol 5D-5L questionnaire includes 5 domains and an optic analogue scale from 0 (worse) up to 100 (best). Each domain (mobility, self care, usual activities, pain / discomfort, anxiety / depression) scores from 1(best score) up to 5 (worse score). The total score of all domains ranges from 5 (best score) up to 25 (worse score).The total perceived quality of life will be graded by the patient.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >65 years,
  • BMI> 35kg/m2,
  • weak cough,
  • heart (i.e heart failure ) and lung comorbidities (i.e COPD),
  • hypercapnia during mechanical ventilation
  • > 72hours on mechanical ventilation
  • failed first spontaneous breathing trial

Exclusion Criteria:

  • Glasgow Coma scale (GCS)<13,
  • pre-existing neuromuscular disease or deformity of Spinal Cord,
  • terminal disease
  • hemodynamic instability with >0.1μg/kg/min noradrenaline
  • patients of immediately need of Non-invasive ventilation after extubation

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): NCT03908658


Contacts
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Contact: Anna Christakou +306977370284 achristakou@phed.uoa.gr
Contact: Irini Patsaki +306942064363 ipatsaki@yahoo.gr

Locations
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Greece
Evangelismos Hospital Recruiting
Athens, Greece, 10676
Contact: Anna Christakou    +306977370284    achristakou@phed.uoa.gr   
Contact: Irini Patsaki    +306942064363    ipatsaki@yahoo.gr   
Sub-Investigator: Emmanouil Papadopoulos         
Sub-Investigator: Alexandros Kouvarakos         
Sub-Investigator: Martha Katartzi         
Principal Investigator: Eleni Ischaki         
Sponsors and Collaborators
Evangelismos Hospital
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Responsible Party: ISCHAKI ELENI, Consultant, ICU Department, Evangelismos Hospital
ClinicalTrials.gov Identifier: NCT03908658    
Other Study ID Numbers: 6345/14-03-2019
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants' data will be available will be available following publication
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: following publication

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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 ISCHAKI ELENI, Evangelismos Hospital:
inspiratory muscle training
Nasal High Flow
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes