Breathing Effort in Covid-19 Pneumonia: Effects of Positive Pressure, Inspired Oxygen Fraction and Decubitus

NCT04885517 | Unknown

• 1 other identifier: 2782
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates the role of positive pressure, inspired oxygen fraction and different decubiti (seated, supine, prone) on breathing effort (as assessed by esophageal pressure swings) in Covid-19 pneumonia (at different disease stages) and in other causes of respiratory failure. The hypothesis is that positive pressure might be deleterious in terms of breathing effort if the main pathological mechanism associated with Sars-CoV-2 infection in the lung is not alveolar damage (as in other causes of respiratory failure) but vascular impairment as previously reported. The effects of high inspired oxygen fractions and decubiti might also be different with respect to other causes of respiratory failure.

Conditions

COVID-19 Pneumonia

Keywords

COVID-19 Pneumonia; Esophageal Pressure; Respiratory Drive

Outcome Measures

Primary Outcomes (1)

• Esophageal pressure swings at different levels of positive end-expiratory pressure (PEEP)

  The main outcome of the study is represented by the difference in esophageal pressure swings (expiratory minus inspiratory) between the three levels of end expiratory pressure applied (0-7-12 cmH2O)

  160 minutes

Secondary Outcomes (2)

• Esophageal pressure swings at different levels of inspired oxygen fraction

  160 minutes

• Esophageal pressure swings at different decubiti

  160 minutes

Study Arms (8)

Spontaneous breathing, Venturi Mask FiO2 0.5, seated decubitus

EXPERIMENTAL

Patient will be evaluated after 20 minutes of spontaneous breathing, with FiO2 0.5 (Venturi Mask), during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.

Device: Esophageal catheter

Spontaneous breathing, Non Rebreathing Mask, seated decubitus

EXPERIMENTAL

Patient will be evaluated after 20 minutes of spontaneous breathing, with FiO2 1 (Non Rebreathing Mask), during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.

Device: Esophageal catheter

Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, seated decubitus

EXPERIMENTAL

Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 0.5, during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.

Device: Esophageal catheter

Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, supine decubitus

EXPERIMENTAL

Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 0.5, during supine decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.

Device: Esophageal catheter

Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, prone decubitus

EXPERIMENTAL

Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 0.5, during prone decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.

Device: Esophageal catheter

Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 1, seated decubitus

EXPERIMENTAL

Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 1.0, during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.

Device: Esophageal catheter

Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 0.5, seated decubitus

EXPERIMENTAL

Patient will be evaluated after 20 minutes of CPAP (12 cmH2O), with FiO2 0.5, during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.

Device: Esophageal catheter

Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 1, seated decubitus

EXPERIMENTAL

Patient will be evaluated after 20 minutes of CPAP (7 cmH2O), with FiO2 1.0, during seated decubitus. Respiratory, haemodynamics, and data on blood gas analysis will be obtained.

Device: Esophageal catheter

Interventions

Esophageal catheter DEVICE

Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine

Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 0.5, seated decubitus; Continuous Positive Airway Pressure (CPAP) 12 cmH2O, FiO2 1, seated decubitus; Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, prone decubitus; Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, seated decubitus; Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 0.5, supine decubitus; Continuous Positive Airway Pressure (CPAP) 7 cmH2O, FiO2 1, seated decubitus; Spontaneous breathing, Non Rebreathing Mask, seated decubitus; Spontaneous breathing, Venturi Mask FiO2 0.5, seated decubitus

Eligibility Criteria

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

You may qualify if:

• Group 1 (Covid-19 early pneumonia)
• Age \> 18
• Positive Sars-CoV 2 nasal swab
• interstitial pneumonia at either CT scan or chest X-ray
• Respiratory failure requiring CPAP for less than 48 hours
• FiO2 ≤0.5 and CPAP≤10 cmH2O
• Group 2 (Covid-19 severe pneumonia)
• Age \> 18
• Positive Sars-CoV 2 nasal swab
• interstitial pneumonia at either CT scan or chest X-ray
• Respiratory failure requiring CPAP
• Signs of severity with CPAP 10 cmH2O and FiO2 0.5: pulse oximetry (SpO2) ≤ 93% associated to either:
• Dyspnea
• Two or more signs of increased respiratory effort (respiratory rate ≥25 bpm, use of accessory inspiratory muscles , tirage, intercostal space depression, nasal flaring, expiratory abdominal efforts, PaCO2 \< 35)
• Group 3 (Non Covid-19 pneumonia)

You may not qualify if:

• Group 1 (Covid-19 early pneumonia)
• Concomitant chronic pulmonary disease
• Chronic heart failure New York Heart Association (NYHA) 3-4
• Bacterial pulmonary associated infection (diagnosed or suspected)
• Pulmonary embolism
• Acute cardiogenic pulmonary edema
• Signs of severity with CPAP 10 cmH2O and FiO2 0.5: SpO2≤ 93% associated to either:
• Dyspnea
• Two or more signs of increased respiratory effort (respiratory rate ≥25 bpm, use of accessory inspiratory muscles , tirage, intercostal space depression, nasal flaring, expiratory abdominal efforts, PaCO2 \< 35)
• At least one sign of respiratory fatigue/decompensation (pH\<7.30 with PaCO2 \>45, respiratory rate \<15 bpm, paradoxal abdominal breathing, mental status alteration)
• Group 2 (Covid-19 severe pneumonia)
• Concomitant chronic pulmonary disease
• Chronic heart failure NYHA 3-4
• Bacterial pulmonary associated infection (diagnosed or suspected)
• Pulmonary embolism

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (1)

A.O.U. San Luigi Gonzaga Di Orbassano

Orbassano, Italy/Turin, 10043, Italy

RECRUITING

Related Publications (15)

• Gattinoni L, Coppola S, Cressoni M, Busana M, Rossi S, Chiumello D. COVID-19 Does Not Lead to a "Typical" Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2020 May 15;201(10):1299-1300. doi: 10.1164/rccm.202003-0817LE. No abstract available.

  PMID: 32228035 RESULT

• Couzin-Frankel J. The mystery of the pandemic's 'happy hypoxia'. Science. 2020 May 1;368(6490):455-456. doi: 10.1126/science.368.6490.455. No abstract available.

  PMID: 32355007 RESULT

• Aliberti S, Radovanovic D, Billi F, Sotgiu G, Costanzo M, Pilocane T, Saderi L, Gramegna A, Rovellini A, Perotto L, Monzani V, Santus P, Blasi F. Helmet CPAP treatment in patients with COVID-19 pneumonia: a multicentre cohort study. Eur Respir J. 2020 Oct 15;56(4):2001935. doi: 10.1183/13993003.01935-2020. Print 2020 Oct.

  PMID: 32747395 RESULT

• Elharrar X, Trigui Y, Dols AM, Touchon F, Martinez S, Prud'homme E, Papazian L. Use of Prone Positioning in Nonintubated Patients With COVID-19 and Hypoxemic Acute Respiratory Failure. JAMA. 2020 Jun 9;323(22):2336-2338. doi: 10.1001/jama.2020.8255.

  PMID: 32412581 RESULT

• Chiumello D, Busana M, Coppola S, Romitti F, Formenti P, Bonifazi M, Pozzi T, Palumbo MM, Cressoni M, Herrmann P, Meissner K, Quintel M, Camporota L, Marini JJ, Gattinoni L. Physiological and quantitative CT-scan characterization of COVID-19 and typical ARDS: a matched cohort study. Intensive Care Med. 2020 Dec;46(12):2187-2196. doi: 10.1007/s00134-020-06281-2. Epub 2020 Oct 21.

  PMID: 33089348 RESULT

• Marini JJ, Gattinoni L. Management of COVID-19 Respiratory Distress. JAMA. 2020 Jun 9;323(22):2329-2330. doi: 10.1001/jama.2020.6825. No abstract available.

  PMID: 32329799 RESULT

• Poston JT, Patel BK, Davis AM. Management of Critically Ill Adults With COVID-19. JAMA. 2020 May 12;323(18):1839-1841. doi: 10.1001/jama.2020.4914. No abstract available.

  PMID: 32215647 RESULT

• Gattinoni L, Giosa L, Bonifazi M, Pasticci I, Busana M, Macri M, Romitti F, Vassalli F, Quintel M. Targeting transpulmonary pressure to prevent ventilator-induced lung injury. Expert Rev Respir Med. 2019 Aug;13(8):737-746. doi: 10.1080/17476348.2019.1638767. Epub 2019 Jul 5.

  PMID: 31274034 RESULT

• Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.

  PMID: 27626833 RESULT

• Tonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC.

  PMID: 32325004 RESULT

• Goligher EC, Jonkman AH, Dianti J, Vaporidi K, Beitler JR, Patel BK, Yoshida T, Jaber S, Dres M, Mauri T, Bellani G, Demoule A, Brochard L, Heunks L. Clinical strategies for implementing lung and diaphragm-protective ventilation: avoiding insufficient and excessive effort. Intensive Care Med. 2020 Dec;46(12):2314-2326. doi: 10.1007/s00134-020-06288-9. Epub 2020 Nov 2.

  PMID: 33140181 RESULT

• Apigo M, Schechtman J, Dhliwayo N, Al Tameemi M, Gazmuri RJ. Development of a work of breathing scale and monitoring need of intubation in COVID-19 pneumonia. Crit Care. 2020 Jul 31;24(1):477. doi: 10.1186/s13054-020-03176-y. No abstract available.

  PMID: 32736637 RESULT

• Vaporidi K, Akoumianaki E, Telias I, Goligher EC, Brochard L, Georgopoulos D. Respiratory Drive in Critically Ill Patients. Pathophysiology and Clinical Implications. Am J Respir Crit Care Med. 2020 Jan 1;201(1):20-32. doi: 10.1164/rccm.201903-0596SO.

  PMID: 31437406 RESULT

• 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 RESULT

• Giosa L, Collins PD, Sciolla M, Cerrone F, Di Blasi S, Macri MM, Davicco L, Laguzzi A, Gorgonzola F, Penso R, Steinberg I, Muraccini M, Perboni A, Russotto V, Camporota L, Bellani G, Caironi P. Effects of CPAP and FiO2 on respiratory effort and lung stress in early COVID-19 pneumonia: a randomized, crossover study. Ann Intensive Care. 2023 Oct 17;13(1):103. doi: 10.1186/s13613-023-01202-0.

  PMID: 37847454 DERIVED

Study Officials

• Pietro Caironi, MD

  San Luigi Gonzaga Hospital

  PRINCIPAL INVESTIGATOR

• Lorenzo Giosa, MD

  San Luigi Gonzaga Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Caironi, Pr

CONTACT

+390119026386; pietro.caironi@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 13, 2021
• Study Start: February 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)