Clinical trial NCT03527797: Diaphragm Protective Ventilation in the Intensive Care Unit
Official title: Diaphragm-protective Mechanical Ventilation in Critically Ill Patients: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Muscle Weakness
Muscle Damage
Respiration, Artificial
Respiratory, Diaphragm
Keywords: Critical illness associated diaphragm weakness
Mechanical ventilation
Critical illness
Respiratory muscle dysfunction
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to an accident, pneumonia or surgery, patients can have severe shortness of breath or lung damage to such an extent that it compromises vital functions. At such times, mechanical ventilation can be lifesaving. The ventilator temporarily takes over the function of the respiratory muscles to ensure adequate uptake of oxygen and removal of carbon dioxide. Mechanical ventilation can usually be stopped quickly after the initial disease has been treated. Unfortunately, in up to 25-40% of ventilated patients it takes several days to weeks before mechanical ventilation can be discontinued, even after treatment of the initial disease. This phenomenon is termed weaning failure. Weakness of the respiratory muscles, such as the diaphragm, is one of the leading causes of weaning failure.

Like other skeletal muscles, the diaphragm can become weakened if it is used too little. This happens often during mechanical ventilation because of excessive assistance provided by the ventilator or use of sedative medication. Excessive activity of the diaphragm can also lead to damage and weakness, just like in other muscles that have to perform excessive amounts for a prolonged period of time. Additionally, excessive work by the diaphragm might have a direct damaging effect on the lungs, which leads to a vicious cycle. As such, it is very important to find a balance between resting the diaphragm (which may lead to weakness) and placing excessive work on the diaphragm (which can damage the diaphragm and possibly the lungs).

In this study, the investigators want to test whether insufficient activity and excessive activity of the diaphragm during mechanical ventilation can be prevented or reduced. The investigators plan to measure the diaphragm activity in 40 participants on mechanical ventilation. Participants will be randomly assigned to the intervention group or the control group. In the intervention group, ventilator support levels will be adjusted according to the observed diaphragm activity, in an attempt to ensure adequate diaphragm activity. The control group receives usual care. The hypothesis is that adjusting the level of support provided by the ventilator is a feasible method to improve the time that the diaphragm operates within acceptable levels of activity over a 24 hour period.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Receives partially supported mechanical ventilation
* Estimated duration of mechanical ventilation after inclusion of at least 24 hours, as estimated by the attending physician

Exclusion Criteria:

* Known neuromuscular disease
* Contra-indications for nasogastric intubation (upper airway surgery, bleeding disorders)
* Expected difficulties in obtaining reliable pressure measurements, such as known airleak into pleural space or diaphragmatic herniation

Primary outcomes:
measure: Adequate diaphragm loading
timeFrame: 24 hours
Secondary outcomes:
measure: Pressure-time product of diaphragm activity
timeFrame: 24 hours
measure: Work of breathing
timeFrame: 24 hours
measure: Markers for lung-protective ventilation
timeFrame: 24 hours
measure: Patient ventilator interaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University medical center
state: Noord-Holland
Study officials:
affiliation: Professor of Experimental Intensive Care
name: Leo M Heunks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intensivist
name: Angélique Spoelstra - de Man, MD, PhD
role: STUDY_CHAIR
References: