Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome

NCT04411459 | Completed

• 1 other identifier: 273/2020/OSS/AUSLBO
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 20

Brief Summary

This multicentric prospective clinical practice study aims at evaluating clinical factors associated with a prolonged invasive mechanical ventilation and other outcomes such as mortality and ICU length of stay in patients affected from COVID-19 related pneumonia and ARDS.

Conditions

COVID-19; Mechanical Ventilation; Quality of Life; Radiologic Increased Density of Lung; Sedation; Complication of Treatment

Keywords

COVID-19; Mechanical Ventilation; Quality of life; Complications during ICU stay

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation and 28 days ventilator free days

  Ventilator free days (VFDs) will be calculated in a time frame of 28 days, the beginning of observation will coincide with the day of intubation and observation will end after successful disconnection from mechanical ventilation. For intubated patients, post extubation non invasive ventilation (NIV) will not be accounted as a ventilation period, in case of interval reintubation within 28 days, VFDs will be counted from the last successful extubation. For tracheostomized patients, ventilator free days will be counted after successful disconnection from mechanical ventilation and interval reconnections will be considered in the ventilation interval as for intubated patients.

  28 days

Secondary Outcomes (11)

• ICU Mortality

  60 days

• 30 days survival after ICU discharge

  30 days

• 90 days survival after ICU discharge

  90 days

• Quality of life at 90 days after ICU discharge measured with 15D instrument

  90 days

• Radiologic aspects - structured description of CT and RX data

  90 days

Study Arms (1)

COVID-19 pneumonia patients

Patients needing intubation and mechanical ventilation for COVID-19 related pneumonia without other primary causes of ICU admission

Other: Invasive mechanical ventilation

Interventions

Invasive mechanical ventilation OTHER

Invasive mechanical ventilation for respiratory failure associated to COVID-19 pneumonia

COVID-19 pneumonia patients

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

This study enrolls patients admitted to ICU needing intubation and mechanical ventilation bacause of respiratory failure for COVID-19 pneumonia without other primary causes for ICU admission

You may qualify if:

• Age ≥ 18 years
• ICU admission because of the need of mechanical ventilation in the context of COVID-19 related pneumonia (swab proven)

You may not qualify if:

• COVID-19 related pneumonia complicating the clinical course of patients admitted to the ICU for another reason (e.g. trauma, stroke)

Sponsors & Collaborators

• Azienda Usl di Bologna: lead
• Lorenzo Gamberini: collaborator

Study Sites (20)

Ospedale Santa Maria Annunziata - Anestesia e Rianimazione

Bagno a Ripoli, FI, Italy

Location

A.O. SS. Antonio, Biagio e Cesare Arrigo - Anestesia e Rianimazione

Alessandria, Italy

Location

Anestesia e Rianimazione - Ospedale Civile di Baggiovara

Baggiovara, Italy

Location

Anestesia e Rianimazione - Ospedale di Bentivoglio

Bentivoglio, Italy

Location

Azienda Unità Sanitaria Locale

Bologna, 40100, Italy

Location

Anestesia e Rianimazione - Ospedale Bellaria

Bologna, Italy

Location

Anestesia e Rianimazione - Policlinico Universitario S.Orsola - Malpighi

Bologna, Italy

Location

Anestesia e Terapia intensiva dei trapianti addominali e chirurgia epatobiliare - Policlinico Universitario S.Orsola - Malpighi

Bologna, Italy

Location

Anestesia e Terapia Intensiva Polivalente - Policlinico Universitario S.Orsola - Malpighi

Bologna, Italy

Location

Ospedale SS. Trinità - Anestesia e Rianimazione

Borgomanero, Italy

Location

Anestesia e Rianimazione - Ospedale M. Bufalini

Cesena, Italy

Location

Anestesia e Rianimazione - Ospedale degli Infermi

Faenza, Italy

Location

Anestesia e Rianimazione Universitaria - Arcispedale Sant'Anna Ferrara

Ferrara, Italy

Location

Anestesia e Rianimazione - Ospedale Morgagni - Pierantoni

Forlì, Italy

Location

Anestesia e Rianimazione - Ospedale di Imola S.Maria della Scaletta

Imola, Italy

Location

Ospedale Santo Stefano - Anestesia e Rianimazione

Prato, Italy

Location

Anestesia e Rianimazione - Ospedale S. Maria delle Croci

Ravenna, Italy

Location

Anestesia e Rianimazione - Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

Location

Anestesia e Rianimazione - Ospedale di Riccione

Riccione, Italy

Location

Anestesia e Rianimazione - Ospedale Infermi

Rimini, Italy

Location

Related Publications (9)

• Yehya N, Harhay MO, Curley MAQ, Schoenfeld DA, Reeder RW. Reappraisal of Ventilator-Free Days in Critical Care Research. Am J Respir Crit Care Med. 2019 Oct 1;200(7):828-836. doi: 10.1164/rccm.201810-2050CP.

  PMID: 31034248 BACKGROUND

• Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.

  PMID: 32291463 BACKGROUND

• Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

  PMID: 32250385 RESULT

• Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.

  PMID: 32227758 RESULT

• Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.

  PMID: 32320003 RESULT

• Dalpiaz G, Gamberini L, Carnevale A, Spadaro S, Mazzoli CA, Piciucchi S, Allegri D, Capozzi C, Neziri E, Bartolucci M, Muratore F, Coppola F, Poerio A, Giampalma E, Baldini L, Tonetti T, Cappellini I, Colombo D, Zani G, Mellini L, Agnoletti V, Damiani F, Gordini G, Laici C, Gola G, Potalivo A, Montomoli J, Ranieri VM, Russo E, Taddei S, Volta CA, Scaramuzzo G. Clinical implications of microvascular CT scan signs in COVID-19 patients requiring invasive mechanical ventilation. Radiol Med. 2022 Feb;127(2):162-173. doi: 10.1007/s11547-021-01444-7. Epub 2022 Jan 16.

  PMID: 35034320 DERIVED

• Gamberini L, Mazzoli CA, Prediletto I, Sintonen H, Scaramuzzo G, Allegri D, Colombo D, Tonetti T, Zani G, Capozzi C, Dalpiaz G, Agnoletti V, Cappellini I, Melegari G, Damiani F, Fusari M, Gordini G, Laici C, Lanza MC, Leo M, Marudi A, Papa R, Potalivo A, Montomoli J, Taddei S, Mazzolini M, Ferravante AF, Nicali R, Ranieri VM, Russo E, Volta CA, Spadaro S; ICU-RER COVID-19 Collaboration; Radiology Collaborators (to be indexed and searchable into PubMed); Pneumology Collaborators (to be indexed and searchable into PubMed). Health-related quality of life profiles, trajectories, persistent symptoms and pulmonary function one year after ICU discharge in invasively ventilated COVID-19 patients, a prospective follow-up study. Respir Med. 2021 Nov-Dec;189:106665. doi: 10.1016/j.rmed.2021.106665. Epub 2021 Oct 22.

  PMID: 34717097 DERIVED

• Gamberini L, Mazzoli CA, Sintonen H, Colombo D, Scaramuzzo G, Allegri D, Tonetti T, Zani G, Capozzi C, Giampalma E, Agnoletti V, Becherucci F, Bertellini E, Castelli A, Cappellini I, Cavalli I, Crimaldi F, Damiani F, Fusari M, Gordini G, Laici C, Lanza MC, Leo M, Marudi A, Nardi G, Ottaviani I, Papa R, Potalivo A, Ranieri VM, Russo E, Taddei S, Volta CA, Spadaro S; ICU-RER COVID-19 Collaboration. Quality of life of COVID-19 critically ill survivors after ICU discharge: 90 days follow-up. Qual Life Res. 2021 Oct;30(10):2805-2817. doi: 10.1007/s11136-021-02865-7. Epub 2021 May 12.

  PMID: 33977415 DERIVED

• Gamberini L, Tonetti T, Spadaro S, Zani G, Mazzoli CA, Capozzi C, Giampalma E, Bacchi Reggiani ML, Bertellini E, Castelli A, Cavalli I, Colombo D, Crimaldi F, Damiani F, Fogagnolo A, Fusari M, Gamberini E, Gordini G, Laici C, Lanza MC, Leo M, Marudi A, Nardi G, Ottaviani I, Papa R, Potalivo A, Russo E, Taddei S, Volta CA, Ranieri VM; ICU-RER COVID-19 Collaboration. Factors influencing liberation from mechanical ventilation in coronavirus disease 2019: multicenter observational study in fifteen Italian ICUs. J Intensive Care. 2020 Oct 15;8:80. doi: 10.1186/s40560-020-00499-4. eCollection 2020.

  PMID: 33078076 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: February 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: October 16, 2020
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (20)