Effects of Inspiration Rise Time on Work of Breathing and Comfort of Conscious Patients on Mechanical Ventilation

NCT00294879 | Completed

• 1 other identifier: LBCH 0601
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Work of breathing

Secondary Outcomes (1)

• patient comfort

Interventions

pressure support ventilation at 0, 5, and 10% IRT PROCEDURE

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Study Officials

• Cornelia WE Hoedemaekers, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 22, 2006
• Study Start: February 1, 2006
• Study Completion: March 1, 2008
• Last Updated: June 2, 2008

Record last verified: 2008-05

Locations

NL (1)