STRATIC: Comparison of 2 Ventilatory Support Strategies During Coronavirus Disease 2019 (Covid-19) Pneumonia

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other)
• Overall Status: Completed
• CT.gov ID: NCT04799691
• Collaborator: (none)
• Enrollment: 133
• Location: 1
• Actual Duration (Months): 11.4
• Patients Per Site Per Month: 11.6

Study Details

Study Description

Brief Summary

This retrospective monocentric study compares 2 ventilatory support strategies on outcomes (length of stay, intubation, mortality) in patients admitted in Intensive Care Unit with Covid-19 related pneumonia : invasive strategy used during the first period and non-invasive strategies (Continuous Positive Airway Pressure, High Flow Nasal Canula, Prone Position) used during the second period.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Procedure: Invasive ventilation strategy; Procedure: Non-invasive ventilation strategies

Study Design

• Study Type: Observational
• Actual Enrollment: 133 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Comparison of 2 Ventilatory Support Strategies in Patients With Covid-19 Pneumonia Admitted in ICU : Retrospective Monocentric Study
• Actual Study Start Date: Feb 1, 2021
• Actual Primary Completion Date: Jan 15, 2022
• Actual Study Completion Date: Jan 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Invasive strategy group Patients admitted in ICU with Covid-19 related pneumonia during COVID19 first period.	Procedure: Invasive ventilation strategy; Use of an invasive ventilatory support strategy
Non-invasive strategy group Patients admitted in ICU with Covid-19 related pneumonia during COVID19 second period.	Procedure: Non-invasive ventilation strategies; Use of non-invasive ventilatory support strategies

Outcome Measures

Primary Outcome Measures

1. Length of stay in ICU [At the moment of ICU discharge or death, up to 3 month]

   Number of days spent in ICU

Secondary Outcome Measures

1. Mortality [At the moment of ICU discharge or death, up to 3 month]

   Rate of patients alive at the moment of intensive care unit discharge

2. Complications [At the moment of ICU discharge or death, up to 3 month]

   Number of complications during intensive care unit stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient with confirmed SARS COV2 infection

• Acute Respiratory Distress Syndrome

• Patient more than 18 year old

Exclusion Criteria:

• Intensive Care Unit admission for extra pulmonary failure

• "Do Not Reanimated" order

• Patient from another Intensive Care Unit

• Patient objection

• Judicial protection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Sainte Musse	Toulon	Var	France	83056

Sponsors and Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

• Study Director: Aude Garnero, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• ClinicalTrials.gov Identifier: NCT04799691
• Other Study ID Numbers: 2021-CHITS-004
• First Posted: Mar 16, 2021
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• 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
• Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: Invasive strategy; Non-invasive strategy; Continuous Positive Airway Pressure; High Flow Nasal Canula; Prone position
• Additional relevant MeSH terms: COVID-19; Pneumonia

Study Results

No Results Posted as of Mar 17, 2022