Inspiratory Muscle Training and Nasal High Flow in Difficult Weaning

The Effectiveness of Inspiratory Muscle Training and Nasal High Flow Oxygen in Difficult Weaning of ICU Patients

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.

Study Overview

• Status: Unknown
• Conditions: High-risk for Reintubation Patients; Weaning Outcome
• Intervention / Treatment: Other: Inspiratory muscle Training and Nasal High Flow; Device: Inspiratory muscle training and Venturi mask

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.

• Study Type: Interventional
• Enrollment (Anticipated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Christakou; Phone Number: +306977370284; Email: achristakou@phed.uoa.gr
• Study Contact Backup: Name: Irini Patsaki; Phone Number: +306942064363; Email: ipatsaki@yahoo.gr

Study Locations

• Greece
  • Athens, Greece, 10676
    • Recruiting
    • Evangelismos Hospital
    • Contact: Anna Christakou; Phone Number: +306977370284; Email: achristakou@phed.uoa.gr
    • Contact: Irini Patsaki; Phone Number: +306942064363; Email: ipatsaki@yahoo.gr
    • Sub-Investigator: Emmanouil Papadopoulos
    • Sub-Investigator: Alexandros Kouvarakos
    • Sub-Investigator: Martha Katartzi
    • Principal Investigator: Eleni Ischaki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of weaning failure	Rate of weaning failure in high-risk for reintubation patients	48 hours after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Inspiratory Pressure	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	Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge
Maximal Expiratory Pressure	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	Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge
Endurance of respiratory muscles	Endurance of respiratory muscles will be calculated comparing the preloading and postloading values of the MIP	Within 2 hours after patient randomization, within 24 hours after extubation , within 24 hours after ICU discharge
Muscle strenght	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)	Within 2 hours after patient randomization, within 24 hours after ICU discharge, within 24 hours before hospital discharge
Functional ability	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	Within 24 hours after ICU discharge, within 24 hours before hospital discharge
Short Form 36 Health Survey (SF-36) questionnaire	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.	Within 24 hours before hospital discharge
Euro-Qol 5 Dimensions 5 Level of severity scale (Euro-Qol 5D-5L scale)	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.	Within 24 hours before hospital discharge

Collaborators and Investigators

• Sponsor: Evangelismos Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2019
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): March 20, 2021

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: inspiratory muscle training; Nasal High Flow
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 6345/14-03-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participants' data will be available will be available following publication
• IPD Sharing Time Frame: following publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No