Serial Daily Diaphragm Ultrasounds in Ventilated Patients

NCT02174029 | Completed

• 1 other identifier: 2013130
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Atrophy or Weakness; Ventilator-associated Lung Injury

Keywords

Atrophy; Ventilator; Induced; Diaphragm; Dysfunction

Outcome Measures

Primary Outcomes (1)

• US measurement of diaphragm and quadriceps thickness

  Diaphragm thickness will be measured once per day and continue until extubation, liberation from mechanical ventilation, transfer to another facility, death, or study completion.

  Participants will be ultrasounded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution

Secondary Outcomes (15)

• Quadriceps muscle thickness

  Participants will be ultrasounded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution

• PEEP (Postive end expiratory pressure) applied by the mechanical ventilator at the time of the ultraspound

  Participants will be ultrasounded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution

• re-intubated within 48 hours

  followed for 48 hours post extubation, or 3 month study period has ended

• mean daily fluid balance

  Will be recorded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution

• mean daily FiO2 (oxygen level administered)

  Will be recorded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution

Study Arms (3)

Ventilation- mandatory mode only

those patient ventilator days during which they had only received a mandatory mode of ventilation

Procedure: Ventilation- mandatory

Ventilation- voluntary mode only

Those patient days on a mechanical ventilator who have not received prior mandatory ventilation during this episode of mechanical ventilation.

Procedure: Ventilation- voluntary mode only

voluntary with preceding mandatory

Those patient ventilator days where the patient had at least one prior day of mandatory mechanical ventilation during this episode of respiratory support.

Procedure: Voluntary with preceding mandatory

Interventions

Ventilation- mandatory PROCEDURE

Patient days during which only a mandatory ventilation mode was used and prior to this no voluntary mode was used.

Ventilation- mandatory mode only

Ventilation- voluntary mode only PROCEDURE

Patient days on a voluntary mode with no preceding days with a majority of time spend on a mandatory mode

Ventilation- voluntary mode only

Voluntary with preceding mandatory PROCEDURE

Patient days on a voluntary vent mode with at least one day prior during which the majority of the vent mode was mandatory.

voluntary with preceding mandatory

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mechanically ventilated critical ill patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steve Reynolds: lead
• Fraser Health: collaborator

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

MeSH Terms

Conditions

Muscular Atrophy; Asthenia; Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Steven Reynolds, MD

  Royal Columbian Hospital, Fraser Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head and Research Director, Department of Critical Care, Royal Columbian Hospital

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 25, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

CA (1)