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CompletedNCT00294879Updated Jun 2, 2008

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

An interventional study of pressure support ventilation at 0, 5, and 10% IRT in Mechanical Ventilation, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-02.

Sponsored by Radboud University Medical Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mechanical Ventilation
03

In context

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • coagulopathy
  • inability to sit
  • hypoxemia and/or hypercapnia and /or hypocapnia
  • Pain score > 5 (on scale 1-10)
  • esophageal abnormalities
  • Pregnancy
  • COPD
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
10 participants (estimated)

Interventions

  • Procedurepressure support ventilation at 0, 5, and 10% IRT
06

What researchers measure

Primary outcomes

  1. Work of breathing

Secondary outcomes

  1. patient comfort

07

Study locations

1 site
  • Radboud University Nijmegen Medical Centre
    Nijmegen, 6500 HB, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00294879
Lead sponsor
Radboud University Medical Center
First posted
Feb 22, 2006
Start date
Feb 2006
Completion
Mar 2008
Last update
Jun 2, 2008

Study contacts

Cornelia WE Hoedemaekers, MD PhD
principal investigator · Radboud University Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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