Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients

NCT04522037 | Unknown

• 1 other identifier: CODYS_2020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Morphine is used in the treatment of dyspnea and polypnea with a proven benefit on the improvement of these symptoms, both etiologically and symptomatically. This medication is used in particular in palliative care for this type of symptom. The Sars CoV2 viral pneumonia table can lead to respiratory distress. In patients with moderate to severe impairment without goal of resuscitation (level of care 3 and 4), the introduction of morphine may sometimes be necessary to relieve respiratory symptoms. These also lead to major exhaustion which can worsen the clinical picture. However, the prescription of morphine is not systematic in front of a respiratory distress table. The investigators hypothesized that early treatment with morphine lead to a better management of dyspnea, quality of live and survival in COVID-19 positive participants patients when there is not resuscitation objective management (level of care 3 and 4). The objective is to measure the efficacy of morphine in the early management of dyspnea, quality of life and survival in COVID-19 positive participants patients treated in the Hospices Civils of Lyon during COVID-19 pandemic.

Conditions

Patients Hospitalized in the Hospices Civils of Lyon; COVID-19 Disease; Moderate to Severe Dyspnea; Without Resuscitation Objective Management

Keywords

COVID-19 disease; level of care 3 and 4; morphinic treatment; dyspnea

Outcome Measures

Primary Outcomes (1)

• Title : Reduction of respiratory rate between Hour 0 and Hour 12 at initiation of morphine treatment

  The respiratory rate is analyzed at Hour 0 and Hour 12 by a scope.

  Hour 0 and Hour 12 after initiation of morphinic treatment

Study Arms (2)

interventional group

patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 receiving morphinic treatment for COVID-19 disease dyspnea.

Other: No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups

control group

patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 not receiving morphinic treatment for COVID-19 disease dyspnea.

Other: No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups

Interventions

No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups OTHER

Respiratory rate is analyzed with the scope (approved by the French national medical authorities)

control group; interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 receiving morphinic and not receiving morphinic treatment for COVID-19 disease dyspnea.

You may qualify if:

• Age over 18 years.
• Having had a Covid-19 respiratory disease confirmed by PCR or TDM or anamnestic criterion for patients living in communities for the elderly (respiratory symptomatology suggestive and at least 3 cases confirmed in the living environment).
• Having had a defined level of care after collegial discussion notified in the file rejecting the external cardiac massage and admission to the intensive care unit (Level 3 and 4 on the protocols of the Hospices Civils de Lyon).
• Collection of non-opposition

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hôpital de la Croix Rousse / GHN

Lyon, 69004, France

RECRUITING

Hôpital Edouard Herriot

Lyon, 69008, France

RECRUITING

Hôpital Lyon Sud

Pierre-Bénite, 69445, France

RECRUITING

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Myriam Legenne

CONTACT

4 72 07 25 79; myriam.legenne@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: August 21, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: February 1, 2021
• Last Updated: August 21, 2020

Record last verified: 2020-07

Locations

FR (3)