Diaphragm Protective Ventilation in the Intensive Care Unit

NCT03527797 | Completed

• 1 other identifier: NL62486.029.17
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Muscle Weakness; Muscle Damage; Respiration, Artificial; Respiratory, Diaphragm

Keywords

Critical illness associated diaphragm weakness; Mechanical ventilation; Critical illness; Respiratory muscle dysfunction

Outcome Measures

Primary Outcomes (1)

• Adequate diaphragm loading

  Percentage of time that the diaphragm operates within physiological levels of activity (Transdiaphragmatic pressure per breath between 3-12 cmH2O).

  24 hours

Secondary Outcomes (4)

• Pressure-time product of diaphragm activity

  24 hours

• Work of breathing

  24 hours

• Markers for lung-protective ventilation

  24 hours

• Patient ventilator interaction

  24 hours

Study Arms (2)

Control

NO INTERVENTION

Standard of care

Intervention

EXPERIMENTAL

Titration of support level

Other: Titration of support level

Interventions

Titration of support level OTHER

Increasing support in case diaphragm activity is too high. Decreasing support in case diaphragm activity is too low.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Receives partially supported mechanical ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University medical center

Amsterdam, North Holland, 1081HV, Netherlands

Location

MeSH Terms

Conditions

Critical Illness; Muscle Weakness; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Leo M Heunks, MD, PhD

  Professor of Experimental Intensive Care

  PRINCIPAL INVESTIGATOR

• Angélique Spoelstra - de Man, MD, PhD

  Intensivist

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 17, 2018
• Study Start: May 16, 2018
• Primary Completion: July 16, 2020
• Study Completion: October 18, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

NL (1)