Who is sponsoring NCT02367170?

NCT02367170 is sponsored by University of Florida.

What drugs are being tested in NCT02367170?

Interventions: Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure, Midazolam, Volitional Measurement of Maximal Inspiratory Pressure (MIP), Inspiratory Muscle Strength Training (IMST), SHAM Inspiratory Muscle Strength Training (IMST), Diaphragm thickness measurement, Blood and Urine samples.

What is the status of NCT02367170?

NCT02367170 is currently TERMINATED.

Last reviewed 2018-04-04 · How we verify

Study: Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care: Project 4A: Inspiratory Muscle Training and Diaphragm Strength

NCT02367170 Phase 1/Phase 2 TERMINATED Results posted

Investigators will assess the effect of exercise on markers of inflammation and protein catabolism. This research study will further our understanding of how treating Chronic Critical illness (CCI) - related respiratory muscle weakness with strength training can not only improve muscle function, but also potentially blunt the inflammation and catabolism of Peristent Inflammation/Immunosuppression and Catabolism (PICS).

Details

Lead sponsor	University of Florida
Phase	Phase 1/Phase 2
Status	TERMINATED
Enrolment	1
Start date	2015-03
Completion	2015-07

Conditions

Sepsis

Interventions

Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure
Midazolam
Volitional Measurement of Maximal Inspiratory Pressure (MIP)
Inspiratory Muscle Strength Training (IMST)
SHAM Inspiratory Muscle Strength Training (IMST)
Diaphragm thickness measurement
Blood and Urine samples

Primary outcomes

A Change in Diaphragm Strength From Baseline as an Effect of Inspiratory Muscle Strength Training (IMST) Intervention and Sham Patients — Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 28
In this randomized, interventional study, 24 CCI patients will be assigned to either a sham group or to receive IMST for up to 28 days. Evaluation of diaphragm/inspiratory muscle strength and muscle thickness will be made with three techniques: 1) non-volitional magnetic stimulation of the phrenic nerves, 2) noninvasive measurement of diaphragm thickness with ultrasound and 3) the standard, clinical method of measuring maximal inspiratory pressure (MIP). Investigators hypothesize that IMST will lead to improvements in all three measures. This study will provide information about possible effective respiratory muscle rehabilitation techniques that are likely to lead to reduced time patients will require mechanical ventilation and improved MIP and weaning outcome in long-term, failure to wean patients

Countries

United States