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Serial Daily Diaphragm Ultrasounds in Ventilated Patients

S

Steve Reynolds

Status

Completed

Conditions

Muscle Atrophy or Weakness
Ventilator-associated Lung Injury

Treatments

Procedure: Voluntary with preceding mandatory
Procedure: Ventilation- mandatory
Procedure: Ventilation- voluntary mode only

Study type

Observational

Funder types

Other

Identifiers

NCT02174029
2013130

Details and patient eligibility

About

When a person is put on a breathing machine the investigators think that the breathing muscles can get weaker. The investigators are not sure how quickly this happens but in some people this leads to problems when they try to breathe on their own without the breathing machine. The diaphragm is at the bottom of a person's chest separating their lungs from what is in their belly and it is a very strong muscle. In fact, it is main muscle that one uses for breathing.

An ultrasound machine is a painless way to see what is happening beneath the skin. It is safe and easy to do. Using an ultrasound the investigators are planning to measure how thick the diaphragm is and how much it changes while a person is on a breathing machine in the ICU.

Getting a better understanding of this condition could lead to improved treatments that might help support patients who require a ventilator for breathing.

The investigators hypothesis is that patients for whom the breathing machine is doing all of the work of breathing, will have their diaphragm thickness gradually decrease and changing to a breathing modem mode where they have to put in more effort the diaphragm thickness will start increasing again.

Full description

The investigators propose to expand the investigators single-centre longitudinal pilot study into a complete study in which the investigators will use B-mode ultrasonography to evaluate daily changes in diaphragm thickness in all critically ill patients on mechanical ventilation (MV) until successful weaned from MV. The impact of patient age, co-morbidities, and the use of various modes of ventilation on diaphragm thickness will be assessed. Diaphragmatic thickness and its change from baseline will be evaluated as predictors of the need for a prolonged wean (>7days).

The investigators hypothesize that in patients on mandatory mode ventilation, diaphragmatic thickness will progressively decrease. Switching from mandatory to assisted breathing modes will correlate with increases in diaphragmatic thickness.

Enrollment

61 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients age ≥19 years in the ICU on ventilation

Exclusion criteria

  • History of diaphragmatic or neuromuscular disease
  • On a home ventilator
  • History of diaphragm surgery
  • Absence of adequate initial US images (3 consecutive days with at least 2 operators)
  • BMI greater than 40

Trial design

61 participants in 3 patient groups

Ventilation- mandatory mode only
Description:
those patient ventilator days during which they had only received a mandatory mode of ventilation
Treatment:
Procedure: Ventilation- mandatory
Ventilation- voluntary mode only
Description:
Those patient days on a mechanical ventilator who have not received prior mandatory ventilation during this episode of mechanical ventilation.
Treatment:
Procedure: Ventilation- voluntary mode only
voluntary with preceding mandatory
Description:
Those patient ventilator days where the patient had at least one prior day of mandatory mechanical ventilation during this episode of respiratory support.
Treatment:
Procedure: Voluntary with preceding mandatory

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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