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Esophageal Manometry in Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT02901158
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Stefan Lundin, Sahlgrenska University Hospital, Sweden

Brief Summary:

Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure.

In this study high resolution solid-state manometry technique was used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure.


Condition or disease
Acute Respiratory Failure

Detailed Description:

Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure.

In this study high resolution solid-state manometry technique was instead used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. The manometry catheter has 36 circumferential sensors at 1 cm intervals. Each sensor has 12 pressure-sensitive segments that add to the signal at that location. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure. Possible differences in tidal variations in esophageal pressure in different parts of the esophagus were assessed.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Esophageal Manometry in Mechanically Ventilated Patients
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : May 2018

Group/Cohort
Critical care patients
Mechanically ventilated patients in the critical care unit
OR-patients
Mechanically ventilated patients in the operating room



Primary Outcome Measures :
  1. Esophageal pressure measurements in mechanically ventilated patients [ Time Frame: Within one hour ]
    Esophageal pressure was measured in mechanically ventilated patients in the critical care unit and in the operating room.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mechanically ventilated patients in the critical care unit and in the operating room.
Criteria

Inclusion Criteria:

  • Patients in the critical care unit receiving mechanical ventilation or Patients anesthetized and undergoing surgery

Exclusion Criteria:

  • Patients with a contraindication to insert a catheter in the esophagus for instance due to an operation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901158


Locations
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Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Stefan Lundin, MD, PhD Sahlgrenska University Hospital, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stefan Lundin, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02901158     History of Changes
Other Study ID Numbers: LUA-74203
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Stefan Lundin, Sahlgrenska University Hospital, Sweden:
esophageal pressure
chest wall elastance
lung elastance
transpulmonary pressure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases