NCT04286490

Brief Summary

Patients suffering from Acute Respiratory Distress Syndrome (ARDS) with a prone position (PP) indication will benefit from measurements of renal resistive index, intra-abdominal pressure (IAP), urinary oxygen tension (uPO2) and ventilatory mechanics in supine position (baseline IAP), after 2 hours in PP at the current IAP value, thirty minutes after patients' abdomen suspension in order to resume baseline IAP and after patients' are turned back to supine position.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

February 18, 2020

Last Update Submit

January 27, 2025

Conditions

Acute Respiratory Distress SyndromeAcute Kidney InjuryProne PositionIntra-Abdominal Hypertension

Outcome Measures

Primary Outcomes (1)

  • change in renal resistive index (RRI)

    RRI measurement will be performed on a right kidney arcuate/interlobar artery, with a high frequency Doppler probe. Three to five consecutive measures will be obtained then RRI computed according to the formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity).

    At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

Secondary Outcomes (13)

  • change in renal medullary oxygen tension

    At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

  • ventilatory mechanics: transpulmonary pressure

    At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

  • ventilatory mechanics: driving pressure

    At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

  • ventilatory mechanics: elastance

    At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

  • haematosis

    At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

  • +8 more secondary outcomes

Study Arms (1)

Prone position

EXPERIMENTAL
Other: Prone position

Interventions

Prone positionOTHER

Abdomen suspension in prone position

Prone position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ARDS patients according to Berlin criteria, intubated, mechanically ventilated
  • with PaO₂/FiO₂ \< 150 mmHg,
  • neuromuscular blockade
  • with an indication of PP done by the physician in charge
  • possibility to differ PP for one hour
  • patients should be hemodynamically stable since at least 4 hours

You may not qualify if:

  • Pregnant or breast-feeding women
  • legal protection, no social security affiliation
  • PP contra-indication
  • nasogastric tube contra-indication
  • extra corporeal membrane oxygenation
  • cardiac arrhythmia
  • obesity
  • advanced cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Grenoble University

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Kidney InjuryIntra-Abdominal Hypertension

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCompartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 27, 2020

Study Start

June 30, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

January 29, 2025

Record last verified: 2025-01

Locations

FR(1)