CClinicalTrials.gg
Status unknownNCT01530282ERNIUpdated Feb 9, 2012

Non-invasive Measurements of Elastance and Resistance

A Phase 2 interventional study of Invasive method and Non invasive method in Respiratory Insufficiency, sponsored by University of Turin, Italy. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-02-09.

Sponsored by University of Turin, Italy · Phase 2, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study summary

The study aims to assess the agreement between respiratory mechanics parameters measured noninvasively by means of brief airways occlusions at the beginning of inspiration and the reference parameters obtained with standard techniques of esophageal and gastric pressure under static and dynamic conditions in a mixed population of ICU patients mechanically ventilated in pressure support ventilation mode.

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Conditions studied

  • Respiratory Insufficiency

Keywords

  • Respiratory Insufficiency [C08.618.846]
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 15 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • intact respiratory drive;
  • PaO2/FiO2 ratio > 150 with a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O;
  • pH between 7.35 and 7.45;
  • patient alert, conscious, and cooperative with a Glasgow Coma Scale ≥ 10.

Exclusion criteria

Exclusion Criteria:

  • infection, sepsis or septic shock; (with fever no)
  • hemodynamic instability;
  • respiratory centres depression;
  • esophageal deformity, or gastric/esophageal illnesses;
  • previous recent gastric/esophageal surgery.
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Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    measurement of respiratory mechanics

    Invasive method: two catheters will be inserted to measure reference respiratory mechanics Non_invasive method: airway pressure measured during a 150-200 ms occlusion at the beginning of inspiration.

    Other: Invasive method · Other: Non invasive method

Interventions

  • OtherInvasive method

    Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)

  • OtherNon invasive method

    Non_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration

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What researchers measure

Primary outcomes

  1. Non-invasive respiratory mechanics measurement

    use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics

    Time frame: 2 hours

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01530282
Lead sponsor
University of Turin, Italy
Responsible party
Marco Ranieri (MD Professor, University of Turin, Italy) — Principal investigator
First posted
Feb 9, 2012
Start date
Feb 2012
Primary completion
Nov 2012 (estimated)
Completion
Nov 2012 (estimated)
Last update
Feb 9, 2012

Study contacts

Vito Marco VM Ranieri, MD
Contact
marco.ranieri@unito.it
+39 0116334001
Gabriela G Ferreyra, MSC
Contact
gabriela.ferreyra@unito.it
+39 0116334001
Vito Marco VM RANIERI, MD
principal investigator · Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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