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Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS: The PROTECTION Pilot Randomized Clinical Trial.
Mauri, Tommaso; Foti, Giuseppe; Fornari, Carla; Grasselli, Giacomo; Pinciroli, Riccardo; Lovisari, Federica; Tubiolo, Daniela; Volta, Carlo Alberto; Spadaro, Savino; Rona, Roberto; Rondelli, Egle; Navalesi, Paolo; Garofalo, Eugenio; Knafelj, Rihard; Gorjup, Vojka; Colombo, Riccardo; Cortegiani, Andrea; Zhou, Jian-Xin; D'Andrea, Rocco; Calamai, Italo; Vidal González, Ánxela; Roca, Oriol; Grieco, Domenico Luca; Jovaisa, Tomas; Bampalis, Dimitrios; Becher, Tobias; Battaglini, Denise; Ge, Huiqing; Luz, Mariana; Constantin, Jean-Michel; Ranieri, Marco; Guerin, Claude; Mancebo, Jordi; Pelosi, Paolo; Fumagalli, Roberto; Brochard, Laurent; Pesenti, Antonio.
  • Mauri T; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; Department of Anesthesia, Critical Care and Emergency, Foundation IRCCS Cà Granda Maggiore Policlinico Hospital, Milan, Italy. Electronic address: tommaso.mauri@unimi.it.
  • Foti G; Anesthesia and Critical Care, San Gerardo Hospital, ASST Monza, Italy; School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.
  • Fornari C; School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.
  • Grasselli G; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; Department of Anesthesia, Critical Care and Emergency, Foundation IRCCS Cà Granda Maggiore Policlinico Hospital, Milan, Italy.
  • Pinciroli R; School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy; Anesthesia and Critical Care Service 1, Niguarda Hospital, Milan, Italy.
  • Lovisari F; Anesthesia and Critical Care Service 1, Niguarda Hospital, Milan, Italy.
  • Tubiolo D; Department of Anesthesia, Critical Care and Emergency, Foundation IRCCS Cà Granda Maggiore Policlinico Hospital, Milan, Italy.
  • Volta CA; Morphology, Surgery and Experimental Medicine, Anesthesia and Intensive Care Unit, University of Ferrara, Ferrara, Italy.
  • Spadaro S; Morphology, Surgery and Experimental Medicine, Anesthesia and Intensive Care Unit, University of Ferrara, Ferrara, Italy.
  • Rona R; Anesthesia and Critical Care, San Gerardo Hospital, ASST Monza, Italy.
  • Rondelli E; Anesthesia and Critical Care, San Gerardo Hospital, ASST Monza, Italy.
  • Navalesi P; Department of Medicine-DIMED, University of Padua, Padua, Italy; Institute of Anesthesia and Intensive Care, Padua Hospital, Padua, Italy.
  • Garofalo E; Anesthesia and Intensive Care, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy.
  • Knafelj R; Center for Internal Intensive Medicine, University Medical Center Ljubljana, Ljubljana, Slovenia.
  • Gorjup V; Center for Internal Intensive Medicine, University Medical Center Ljubljana, Ljubljana, Slovenia.
  • Colombo R; Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Milan, Italy.
  • Cortegiani A; Section of Anesthesia, Analgesia, Intensive Care and Emergency, Department of Surgical, Oncological and Oral Science, Policlinico Paolo Giaccone, University of Palermo, Palermo, Italy.
  • Zhou JX; Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • D'Andrea R; Department of Anesthesiology, Intensive Care and Transplants, University Hospital St. Orsola-Malpighi, Bologna, Italy.
  • Calamai I; AUSL Toscana Centro, Unit of Anesthesia and Resuscitation, San Giuseppe Hospital, Empoli, Italy.
  • Vidal González Á; Hospital Universitario Fundación Jiménez Díaz de Madrid, Madrid, Spain.
  • Roca O; Critical Care Department, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain; Ciber Enfermedades Respiratorias (CibeRes), Instituto de Salud Carlos III, Madrid, Spain.
  • Grieco DL; Department of Anesthesiology and Intensive Care Medicine, Catholic University of the Sacred Heart, IRCCS Fondazione Policlinico A. Gemelli, Rome, Italy.
  • Jovaisa T; Critical Care Service, Anaesthetics Division, Barking Havering and Redbridge University Hospitals NHS Trust, London, United Kingdom.
  • Bampalis D; Intensive Care Unit, Larissa General Hospital, Larissa, Greece.
  • Becher T; Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.
  • Battaglini D; Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy; Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy.
  • Ge H; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
  • Luz M; Intensive Care Department, Hospital da Mulher, Salvador, Bahia, Brazil; Intensive Care Department, Hospital Universitário Professor Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil.
  • Constantin JM; Sorbonne University, GRC 29, AP-HP, DMU DREAM, Department of Anesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Paris, France.
  • Ranieri M; Department of Anesthesiology, Intensive Care and Transplants, University Hospital St. Orsola-Malpighi, Bologna, Italy.
  • Guerin C; Médecine Intensive-Réanimation Groupement Hospitalier Edouard Herriot, Université de Lyon Faculté de Médecine Lyon-Est, Lyon, France.
  • Mancebo J; Servei de Medicina Intensiva, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
  • Pelosi P; Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy; Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy.
  • Fumagalli R; School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy; Anesthesia and Critical Care Service 1, Niguarda Hospital, Milan, Italy.
  • Brochard L; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
  • Pesenti A; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; Department of Anesthesia, Critical Care and Emergency, Foundation IRCCS Cà Granda Maggiore Policlinico Hospital, Milan, Italy.
Chest ; 159(4): 1426-1436, 2021 04.
Article in English | MEDLINE | ID: covidwho-921554
Semantic information from SemMedBD (by NLM)
1. Sighing respiration PROCESS_OF Patients
Subject
Sighing respiration
Predicate
PROCESS_OF
Object
Patients
2. Respiratory Distress Syndrom PROCESS_OF C0030705
Subject
Respiratory Distress Syndrom
Predicate
PROCESS_OF
Object
C0030705
3. Acute Hypoxemic Respiratory Failure PROCESS_OF Patients
Subject
Acute Hypoxemic Respiratory Failure
Predicate
PROCESS_OF
Object
Patients
4. Lung LOCATION_OF Elastance
Subject
Lung
Predicate
LOCATION_OF
Object
Elastance
5. Intubated PROCESS_OF Patients
Subject
Intubated
Predicate
PROCESS_OF
Object
Patients
6. Pressure breathing TREATS Patients
Subject
Pressure breathing
Predicate
TREATS
Object
Patients
7. Respiratory rate ASSOCIATED_WITH Sighing respiration
Subject
Respiratory rate
Predicate
ASSOCIATED_WITH
Object
Sighing respiration
8. Sighing respiration PROCESS_OF Patients
Subject
Sighing respiration
Predicate
PROCESS_OF
Object
Patients
9. Respiratory Distress Syndrome, Adult PROCESS_OF Patients
Subject
Respiratory Distress Syndrome, Adult
Predicate
PROCESS_OF
Object
Patients
10. Acute Hypoxemic Respiratory Failure PROCESS_OF Patients
Subject
Acute Hypoxemic Respiratory Failure
Predicate
PROCESS_OF
Object
Patients
11. Lung LOCATION_OF Elastance
Subject
Lung
Predicate
LOCATION_OF
Object
Elastance
12. Intubated PROCESS_OF Patients
Subject
Intubated
Predicate
PROCESS_OF
Object
Patients
13. Pressure breathing TREATS Patients
Subject
Pressure breathing
Predicate
TREATS
Object
Patients
14. Respiratory rate ASSOCIATED_WITH Sighing respiration
Subject
Respiratory rate
Predicate
ASSOCIATED_WITH
Object
Sighing respiration
ABSTRACT

BACKGROUND:

Sigh is a cyclic brief recruitment maneuver previous physiologic studies showed that its use could be an interesting addition to pressure support ventilation to improve lung elastance, decrease regional heterogeneity, and increase release of surfactant. RESEARCH QUESTION Is the clinical application of sigh during pressure support ventilation (PSV) feasible? STUDY DESIGN AND

METHODS:

We conducted a multicenter noninferiority randomized clinical trial on adult intubated patients with acute hypoxemic respiratory failure or ARDS undergoing PSV. Patients were randomized to the no-sigh group and treated by PSV alone, or to the sigh group, treated by PSV plus sigh (increase in airway pressure to 30 cm H2O for 3 s once per minute) until day 28 or death or successful spontaneous breathing trial. The primary end point of the study was feasibility, assessed as noninferiority (5% tolerance) in the proportion of patients failing assisted ventilation. Secondary outcomes included safety, physiologic parameters in the first week from randomization, 28-day mortality, and ventilator-free days.

RESULTS:

Two-hundred and fifty-eight patients (31% women; median age, 65 [54-75] years) were enrolled. In the sigh group, 23% of patients failed to remain on assisted ventilation vs 30% in the no-sigh group (absolute difference, -7%; 95% CI, -18% to 4%; P = .015 for noninferiority). Adverse events occurred in 12% vs 13% in the sigh vs no-sigh group (P = .852). Oxygenation was improved whereas tidal volume, respiratory rate, and corrected minute ventilation were lower over the first 7 days from randomization in the sigh vs no-sigh group. There was no significant difference in terms of mortality (16% vs 21%; P = .337) and ventilator-free days (22 [7-26] vs 22 [3-25] days; P = .300) for the sigh vs no-sigh group.

INTERPRETATION:

Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk. TRIAL REGISTRY ClinicalTrials.gov; No. NCT03201263; URL www.clinicaltrials.gov.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Respiratory Distress Syndrome / Respiratory Insufficiency / Positive-Pressure Respiration Subject: Respiratory Distress Syndrome / Respiratory Insufficiency / Positive-Pressure Respiration Type of study: Controlled clinical trial Language: English Journal: Chest Clinical aspect: Etiology / Therapy Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Respiratory Distress Syndrome / Respiratory Insufficiency / Positive-Pressure Respiration Subject: Respiratory Distress Syndrome / Respiratory Insufficiency / Positive-Pressure Respiration Type of study: Controlled clinical trial Language: English Journal: Chest Clinical aspect: Etiology / Therapy Year: 2021
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