Serial Daily Diaphragm Ultrasounds in Ventilated Patients

NCT ID: NCT02174029

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-09-30

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.

Detailed 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.

Conditions

Muscle Atrophy or Weakness; Ventilator-associated Lung Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ventilation- mandatory mode only

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

Ventilation- mandatory

Intervention Type: PROCEDURE

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

Ventilation- voluntary mode only

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

Ventilation- voluntary mode only

Intervention Type: PROCEDURE

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

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.

Voluntary with preceding mandatory

Intervention Type: PROCEDURE

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

Interventions

Ventilation- mandatory

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

Intervention Type: PROCEDURE

Ventilation- voluntary mode only

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

Intervention Type: PROCEDURE

Voluntary with preceding mandatory

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fraser Health

OTHER

Sponsor Role: collaborator

Steve Reynolds

OTHER

Sponsor Role: lead

Responsible Party

Steve Reynolds

Head and Research Director, Department of Critical Care, Royal Columbian Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steven Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Columbian Hospital, Fraser Health

Locations

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Countries

Canada

Other Identifiers

2013130

Identifier Type: -

Identifier Source: org_study_id