Pressure support ventilation at 0, 5, and 10% IRT in Mechanical Ventilation - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Mechanical Ventilation

Intervention / Treatment

Procedure: pressure support ventilation at 0, 5, and 10% IRT

Detailed Description

Introduction Pressure Support Ventilation is widely used in patients in the ICU. Matching the patient's respiratory needs with adequate ventilator settings is necessary to ensure a low work of breathing (WOB) and maximal patient comfort. The inspiratory rise time (IRT) determines the time to reach the selected airway pressure. A short IRT results in a high peak inspiratory flow and a short time to reach that peak, but is also associated with the development of turbulent flow, resulting in increased WOB. Aim of this study is to investigate the effects of different IRT settings on WOB and patient comfort during pressure support ventilation.

Methods We will performed a prospective, single blind cohort study in patients on Pressure Support Ventilation. 10 healthy adult patients admitted to the ICU after elective facial or neck surgery will be included. All patients will be ventilated in pressure support mode using a Servo 300 ventilator (Siemens. Elema, Solna, Sweden), with a positive end expiratory pressure of 5 cm H2O, pressure support level of 12 cm H2O above PEEP and an inspiratory oxygen fraction of 0.40. Patients have to be awake and cooperative (Ramsay 2). WOB will be measured with an esophageal balloon, and miniature flowmeter (Bicore system). Breathing comfort will be evaluated using a visual analogue scale (VAS) ranging from 1 to 10. WOB and patient comfort will be measured (in random order) at 0, 5, and 10% IRT. For statistical analysis the two-way analysis of variance will used. A p value of < 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Nijmegen, Netherlands, 6500 HB
    - Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

awake and cooperative patient
ICU admission following surgery of head or neck

Exclusion Criteria:

coagulopathy
inability to sit
hypoxemia and/or hypercapnia and /or hypocapnia
Pain score > 5 (on scale 1-10)
esophageal abnormalities
Pregnancy
COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Work of breathing

Secondary Outcome Measures

Outcome Measure
patient comfort

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

Principal Investigator: Cornelia WE Hoedemaekers, MD PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion

December 7, 2022

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria