High Flow Nasal Cannulae vs Venturi Mask in Respiratory Failure Due to Pneumonia

NCT03515031 | Recruiting

• 1 other identifier: PapaGiovanniH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the efficacy of treatment with HFNC (group A) compared to administration of oxygen therapy by Venturi mask (group B, standard therapy) in terms of reaching of endotracheal intubation criteria during acute respiratory failure due to severe pneumonia. Inclusion Criteria: Respiratory rate (RR) at rest ≥20 bpm or presence of respiratory distress (severe dyspnoea at rest or use of accessory respiratory muscles or abdominal paradox); PaO2 / FiO2 ≤250 during oxygenation with Venturi Oxygenation mask at FiO2 = 50% administered for at least 60 minutes; Diagnosis of pneumonia as the sole cause of acute respiratory failure. Randomization: 150 consecutive patients will be randomized either to High Flow Nasal Cannula Oxygenation (75 patients, HFNCO with flow ≥ 60 L/min and FiO2 to maintain SpO2 ≥ ) or Venturi Mask Oxygenation (control, 75 patients). Patients from both groups will be treated with antibiotic therapy according to the IDSA/ATS 2007 guidelines for community-acquired pneumonia and the IDSA/ATS 2016 guidelines for hospital-acquired pneumonia. Intubation Criteria: MAJOR CRITERIA: Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability Need for sedation MINOR CRITERIA (maintained for ≥1h): Reduction ≥30% of the value of the PaO2/FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale Persistence or onset of respiratory distress Vital parameters, Kelly scale and arterial blood gas analysis (BGA) will be performed on admission, and at 1, 24, at 48 hours, at the achievement of clinical stability, and whenever there is a clinical worsening. Patients enrolled in HFNC arm will continue HFNC oxygenation until clinical stability, defined as: Body temperature ≤ 37°C and ≥36°C for 24 consecutive hours Good ability in swallowing CRP and WBC normalization trend than the admission exams Hemodynamic stability Lack of respiratory distress SpO2 94-98% The primary outcome variable is the proportion of patients who reach the endotracheal intubation criteria - regardless of the actual intubation rate - within the first 48 hours of treatment. The primary analysis will be performed on the ITT population

Conditions

Respiratory Insufficiency; Pneumonia

Keywords

High Flow Nasal Cannula; Venturi mask

Outcome Measures

Primary Outcomes (1)

• Clinical Failure

  The primary endpoint is the achievement of clinical failure defined as: At least one of major criteria Or At least 2 or more of the minor criteria maintained for at least 1 consecutive hour: MAJOR CRITERIA: Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability (Heart Rate ≤ 50 bpm with loss of alertness or Systolic Blood Pressure ≤ 70 mmHg) Need for sedation MINOR CRITERIA (observed for ≥ 1 hour): Reduction ≥30% of the value of the PaO 2 / FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale (see Appendix II) Persistence or onset of respiratory distress ( severe dyspnea or use of accessories respiratory muscles or paradoxical abdominal motion)

  Participants will be followed for the duration of hospital stay, for a maximum of 30 days

Secondary Outcomes (4)

• 30-day mortality after admission

  day 30

• improvement of respiratory exchanges compared to baseline

  hospital admission (=day 1), day 2, until the achievement of clinical stability

• adverse events

  Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week

• hospital stay

  Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week

Study Arms (2)

High Flow Nasal Cannula Oxygenation

EXPERIMENTAL

High Flow Nasal Cannula Oxygenation with a minimum flow ≥ 60L / min, and an FiO2 such as to maintain a SpO2 ≥ 92% for at least 48 hours until clinical stability

Device: High Flow Nasal Cannula Oxygenation

Venturi Mask Oxygenation

ACTIVE COMPARATOR

Venturi Mask Oxygenation, with an FiO2 such as to maintain an SpO2 ≥ 92% for at least 48 hours until clinical stability

Device: Venturi Mask Oxygenation

Interventions

High Flow Nasal Cannula Oxygenation DEVICE

Delivery of humidified and heated (37ºC) high flow oxygen

High Flow Nasal Cannula Oxygenation

Venturi Mask Oxygenation DEVICE

delivery of high flow oxygen

Venturi Mask Oxygenation

Eligibility Criteria

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

You may qualify if:

• male or female of any ethnic group
• age greater than or equal to 18 years;
• respiratory rate (RR) at rest ≥ 20 breaths/minute or presence of respiratory distress (severe - dyspnea at rest or use of accessory respiratory muscles or paradox abdominal movement) PaO 2/ FiO 2 ≤250 during oxygen therapy with Venturi mask with FiO 2 50% administered for at least 60 minutes;
• diagnosis of pneumonia as the unique cause of acute respiratory failure
• informed consent obtained from the patient or the closest relative in case of patient's inability to give it.

You may not qualify if:

• other diagnoses (instead of pneumonia) as a cause of acute respiratory failure
• unstable angina and acute myocardial infarction in place;
• Acute respiratory acidosis with pH \<7.35 and PaCO 2 \> 45 mmHg;
• systolic blood pressure \<90 mmHg unresponsive to fluids or with amines
• severe arrhythmias;
• epileptic seizures;
• the degree of vigilance depending on the Kelly scale \> 3 (see Appendix II)
• impaired swallowing, which increases the risk of pneumonia aspiration inability to protect airways
• craniofacial trauma or burns
• uncooperative patient
• presence of open wound (skull, chest, abdomen)
• respiratory arrest or need for intubation
• ongoing pregnancy or suspected

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Vicky Rubini

Bergamo, 24127, Italy

RECRUITING

Related Publications (6)

• Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

  PMID: 25981908 BACKGROUND

• Liesching TN, Lei Y. Efficacy of High-Flow Nasal Cannula Therapy in Intensive Care Units. J Intensive Care Med. 2017 Jan 1:885066616689043. doi: 10.1177/0885066616689043. Online ahead of print.

  PMID: 28110612 BACKGROUND

• Ischaki E, Pantazopoulos I, Zakynthinos S. Nasal high flow therapy: a novel treatment rather than a more expensive oxygen device. Eur Respir Rev. 2017 Aug 9;26(145):170028. doi: 10.1183/16000617.0028-2017. Print 2017 Sep 30.

  PMID: 28794144 BACKGROUND

• Brambilla AM, Aliberti S, Prina E, Nicoli F, Del Forno M, Nava S, Ferrari G, Corradi F, Pelosi P, Bignamini A, Tarsia P, Cosentini R. Helmet CPAP vs. oxygen therapy in severe hypoxemic respiratory failure due to pneumonia. Intensive Care Med. 2014 Jul;40(7):942-9. doi: 10.1007/s00134-014-3325-5. Epub 2014 May 10.

  PMID: 24817030 BACKGROUND

• Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.

  PMID: 17278083 BACKGROUND

• Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.

  PMID: 27418577 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Pneumonia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Lung Diseases

Study Officials

• roberto cosentini, MD

  ASST Papa Giovanni XXIII, Bergamo, Italy

  STUDY DIRECTOR

Central Study Contacts

roberto cosentini, MD

CONTACT

+39 338 600 2601; r.cosentini@gmail.com

andrea duca, MD

CONTACT

+39 339 698 0728; andreaducamd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will be blind to the treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Head of Emergency Room

Model Details: open randomized controlled trial

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 3, 2018
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)