PEEP Setting in COVID19-related ARDS

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT05115526
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

The best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from acute respiratory distress syndrome is still matter of debate. Electrical impedance tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an optimized ventilation homogeneity.

Condition or Disease	Intervention/Treatment	Phase
ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2	Other: PEEP setting

Detailed Description

COVID-19 related ARDS patients admitted to the ICU in March 2021 requiring mechanical ventilation were enrolled. Patients were monitored by an esophageal catheter and a 32-electrode EIT device. Within 48 hours after the start of mechanical ventilation, different levels of PEEP were applied based upon PEEP/ Fraction of inspired oxygen tables, positive end-expiratory transpulmonary (PL)/ FiO2 table, and EIT. Respiratory mechanics variables were recorded.

Study Design

• Study Type: Observational
• Actual Enrollment: 17 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Positive End-expiratory Pressure Setting in COVID-19 Related ARDS : Comparison Between Electrical Impedance Tomography, PEEP/ Fraction of Inspired Oxygen Tables, and Transpulmonary Pressure.
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Mar 15, 2021
• Actual Study Completion Date: May 1, 2021

Outcome Measures

Primary Outcome Measures

1. Value of PEEP [a single determination, within 24-48 hours after mechanical ventilation initiation]

   different PEEP values obtained through using different methods

Secondary Outcome Measures

1. Respiratory mechanics [a single determination, within 24-48 hours after mechanical ventilation initiation]

   Respiratory mechanics (plateau pressure, driving pressure, compliance, mechanical power) following different PEEP settings

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• COVID19-related ARDS under invasive mechanical ventilation

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Réanimation Médicale, Hôpital Central	Nancy		France

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05115526
• Other Study ID Numbers: 2021PI117
• First Posted: Nov 10, 2021
• Last Update Posted: Nov 10, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Nov 10, 2021