COVID-19 Acute Respiratory Distress SyndromeNCT05178160
Positive End Espiratory Pressure Trial in Coronavirus Disease 19 Treated With Continuous Positive Airway Pressure
A study testing PEEP Standard Protocol in people with COVID-19 Acute Respiratory Distress Syndrome, run by Santa Maria delle Grazie Hospital at 1 site in Italy.
Trial summary
Consecutive patients with hypoxemic respiratory failure, CT evidence of bilateral pneumonia and diagnosis of Coronavirus Disease 19 (COVID-19) with molecular nasopharyngeal swab consecutively admitted to the COVID Care Unit of the "Santa Maria delle Grazie" Hospital were enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- PEEP Standard Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years;
- diagnosis of SARS-CoV-2 infection confirmed by means of RT-PCR on specimen from nasopharyngeal swab;
- bilateral interstitial pneumonia at CT scan;
- hypoxemic respiratory failure defined as PaO2/FiO2 < 200 at blood gas analyses.
Who cannot join
- type 2 respiratory failure;
- hemodynamic instability requiring vasopressors and/or inotropes support;
- CT evidence of pneumothorax/pneumomediastinum;
- concomitant acute medical disease (stroke; myocardial infarction; septic shock; gastrointestinal bleeding; acute renal failure requiring dialysis)
Trial locations and contacts
1 site in 1 country.
Italy1 site
COVID CARE UNIT Santa Maria delle Grazie Hospital
Pozzuoli, Naples, 80078
About this study
Official title: Lung Ultrasound-Guided PEEP Titration Versus Standard Protocol in Patients With COVID-19 ARDS Treated With CPAP: a Single Center Prospective Trial
Consecutive patients with hypoxemic respiratory failure, CT evidence of bilateral pneumonia and diagnosis of Coronavirus Disease 19 (COVID-19) with molecular nasopharyngeal swab consecutively admitted to the COVID Care Unit of the "Santa Maria delle Grazie" Hospital were enrolled. All the patients with clinical indication for Continuous Positive Airway Pressure (CPAP) were randomized 1:1 into two groups: Group A received a fixed Positive End Expiratory Pressure (PEEP) of 10 centimetre of water (cmH2O), Group B underwent the PEEP trial to identify the optimal PEEP (defined as the highest value that preceded the appearance of the "lung pulse" at lung ultrasound and that determined an increase in PaO2/FiO2 by at least 20%). Primary endpoint was defined as a composite in-hospital mortality+intubation, secondary endpoint was the improvement of PaO2/FiO2. As safety indicator, the incidence of pneumothorax was collected.
Read the detailed description
Consecutive COVID-19 patients affected by Acute Respiratory Syndrome (ARDS) admitted to COVID Care Unit of "Santa Maria delle Grazie" Hospital, Pozzuoli (Naples, Italy), were prospectively enrolled in the study. Inclusion criteria were: age > 18 years, diagnosis of Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) infection confirmed by means of a nucleic acid test by real-time reverse transcription polymerase chain reaction (RT-PCR) on specimen from nasopharyngeal swab, bilateral interstitial pneumonia at CT scan; hypoxemic respiratory failure defined as PaO2 (partial pressure of oxygen) to FiO2 (fraction of inspired oxygen) ratio < 200.
As exclusion criteria were considered: type 2 respiratory failure; hemodynamic instability requiring vasopressors and/or inotropes support; CT evidence of pneumothorax/pneumomediastinum; concomitant acute medical disease (stroke; myocardial infarction; septic shock; gastrointestinal bleeding; acute renal failure requiring dialysis) who could affect the prognosis independent from COVID - 19.
All the patients enrolled underwent clinical history, physical examination, laboratory tests, arterial blood gas analysis, lung ultrasound, chest CT. During the hospital stay, the patients were treated according to the standard and experimental protocol available; therapies administered, and collateral effects were collected.
All participants gave their written informed consent. All the patients eligible to receive CPAP were consecutively 1:1 randomized to PEEP trial (Group A) or standard treatment (Group B).
In the Group A, PEEP was increased from 5 to 7.5 and 10 cmH20 in 30-minute steps during which lung ultrasound and blood gas analyses were repeated. PEEP responsiveness was evaluated comparing ultrasound findings and arterial blood gas parameters during oxygen supplementation with helmet-CPAP at different PEEP levels (5, 7.5 and 10, respectively), maintaining the same FiO2. A PEEP-responder is defined as a subject with clinical and/or arterial blood gases improvement with helmet-CPAP without signs of lung hyperinflation. The best PEEP was defined as the PEEP value before the appearance of lung pulse and with a PaO2/FiO2 levels stable or major than 20% in comparison to the basal value. In the Standard practice group CPAP was set at 10 cmH2O for all patients and a blood gas analysis was performed after 2 hours.
Endotracheal intubation was considered in presence of impaired respiratory mechanics, worsening of respiratory acidosis, decreased mental status.
Primary outcome was defined by a composite of hospital mortality and need of endotracheal intubation. Secondary outcome was considered the effect of CPAP on PaO2/FiO2 and respiratory rate. As a safety indicator the incidence of pneumothorax was considered.
- Being tested
- PEEP Standard Protocol
- Keywords
- COVID-19, PEEP trial, CPAP, lung ultrasound
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP Standard ProtocolOther
All the patients treated with CPAP receive a PEEP standard of 10 cmH2O with a fixed FiO2
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | All the patients undergo to helmet-CPAP setting PEEP at 10 cmH2O and performing a blood gas analysis after 2 hours Receives: Other: PEEP Standard Protocol |
| Group B | Experimental | All the patients undergo to helmet-CPAP. PEEP was increased from 5 to 7.5 and 10 cmH20 in 30-minute steps during which lung ultrasound and blood gas analyses were repeated. The best PEEP was setted as the PEEP value before the appearance of lung pulse and with a PaO2/FiO2 levels stable or major than 20% in comparison to the basal value Receives: Other: PEEP Standard Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
composite of hospital mortality and need of endotracheal intubation
Measured: From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.
Secondary outcomes (1)
Secondary outcome
effect on P/F ratio at blood gas analyses
Measured: From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Maria delle Grazie Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Bosso, Santa Maria delle Grazie Hospital
- Investigators
- Fabio G Numis, MD, Study chair, Santa Maria delle Grazie Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178160
- Sponsor's protocol ID
- N2N-01-COVID 19
- Status last verified
- Jan 2022
- First submitted
- 31 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosso G, Allegorico E, Pagano A, Porta G, Serra C, Minerva V, Mercurio V, Russo T, Altruda C, Arbo P, De Sio C, Dello Vicario F, Numis FG. Lung ultrasound as diagnostic tool for SARS-CoV-2 infection. Intern Emerg Med. 2021 Mar;16(2):471-476. doi: 10.1007/s11739-020-02512-y. Epub 2020 Oct 3.
PubMed 33011929Pagano A, Porta G, Bosso G, Allegorico E, Serra C, Dello Vicario F, Minerva V, Russo T, Altruda C, Arbo P, Mercurio V, Numis FG. Non-invasive CPAP in mild and moderate ARDS secondary to SARS-CoV-2. Respir Physiol Neurobiol. 2020 Sep;280:103489. doi: 10.1016/j.resp.2020.103489. Epub 2020 Jul 3.
PubMed 32629100Paolini V, Faverio P, Aliberti S, Messinesi G, Foti G, Sibila O, Monzani A, De Giacomi F, Stainer A, Pesci A. Positive end expiratory pressure in acute hypoxemic respiratory failure due to community acquired pneumonia: do we need a personalized approach? PeerJ. 2018 Jan 30;6:e4211. doi: 10.7717/peerj.4211. eCollection 2018.
PubMed 29404202
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound-Guided PEEP Titration Versus Standard Protocol in Patients With COVID-19 ARDS Treated With CPAP: a Single Center Prospective Trial
- ClinicalTrials.gov ID
- NCT05178160
- Acronym / sponsor ID
- N2N-01-COVID 19
- Keywords
- COVID-19, PEEP trial, CPAP, lung ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Santa Maria delle Grazie HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Consecutive patients with hypoxemic respiratory failure, CT evidence of bilateral pneumonia and diagnosis of Coronavirus Disease 19 (COVID-19) with molecular nasopharyngeal swab consecutively admitted to the COVID Care Unit of the "Santa Maria delle Grazie" Hospital were enrolled. All the patients with clinical indication for Continuous Positive Airway Pressure (CPAP) were randomized 1:1 into two groups: Group A received a fixed Positive End Expiratory Pressure (PEEP) of 10 centimetre of water (cmH2O), Group B underwent the PEEP trial to identify the optimal PEEP (defined as the highest value that preceded the appearance of the "lung pulse" at lung ultrasound and that determined an increase in PaO2/FiO2 by at least 20%). Primary endpoint was defined as a composite in-hospital mortality+intubation, secondary endpoint was the improvement of PaO2/FiO2. As safety indicator, the incidence of pneumothorax was collected.
Detailed description
Consecutive COVID-19 patients affected by Acute Respiratory Syndrome (ARDS) admitted to COVID Care Unit of "Santa Maria delle Grazie" Hospital, Pozzuoli (Naples, Italy), were prospectively enrolled in the study. Inclusion criteria were: age > 18 years, diagnosis of Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) infection confirmed by means of a nucleic acid test by real-time reverse transcription polymerase chain reaction (RT-PCR) on specimen from nasopharyngeal swab, bilateral interstitial pneumonia at CT scan; hypoxemic respiratory failure defined as PaO2 (partial pressure of oxygen) to FiO2 (fraction of inspired oxygen) ratio < 200.
As exclusion criteria were considered: type 2 respiratory failure; hemodynamic instability requiring vasopressors and/or inotropes support; CT evidence of pneumothorax/pneumomediastinum; concomitant acute medical disease (stroke; myocardial infarction; septic shock; gastrointestinal bleeding; acute renal failure requiring dialysis) who could affect the prognosis independent from COVID - 19.
All the patients enrolled underwent clinical history, physical examination, laboratory tests, arterial blood gas analysis, lung ultrasound, chest CT. During the hospital stay, the patients were treated according to the standard and experimental protocol available; therapies administered, and collateral effects were collected.
All participants gave their written informed consent. All the patients eligible to receive CPAP were consecutively 1:1 randomized to PEEP trial (Group A) or standard treatment (Group B).
In the Group A, PEEP was increased from 5 to 7.5 and 10 cmH20 in 30-minute steps during which lung ultrasound and blood gas analyses were repeated. PEEP responsiveness was evaluated comparing ultrasound findings and arterial blood gas parameters during oxygen supplementation with helmet-CPAP at different PEEP levels (5, 7.5 and 10, respectively), maintaining the same FiO2. A PEEP-responder is defined as a subject with clinical and/or arterial blood gases improvement with helmet-CPAP without signs of lung hyperinflation. The best PEEP was defined as the PEEP value before the appearance of lung pulse and with a PaO2/FiO2 levels stable or major than 20% in comparison to the basal value. In the Standard practice group CPAP was set at 10 cmH2O for all patients and a blood gas analysis was performed after 2 hours.
Endotracheal intubation was considered in presence of impaired respiratory mechanics, worsening of respiratory acidosis, decreased mental status.
Primary outcome was defined by a composite of hospital mortality and need of endotracheal intubation. Secondary outcome was considered the effect of CPAP on PaO2/FiO2 and respiratory rate. As a safety indicator the incidence of pneumothorax was considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: PEEP Standard ProtocolAll the patients undergo to helmet-CPAP setting PEEP at 10 cmH2O and performing a blood gas analysis after 2 hours |
| Group B | Experimental | Other: PEEP Standard ProtocolAll the patients undergo to helmet-CPAP. PEEP was increased from 5 to 7.5 and 10 cmH20 in 30-minute steps during which lung ultrasound and blood gas analyses were repeated. The best PEEP was setted as the PEEP value before the appearance of lung pulse and with a PaO2/FiO2 levels stable or major than 20% in comparison to the basal value |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years;
- diagnosis of SARS-CoV-2 infection confirmed by means of RT-PCR on specimen from nasopharyngeal swab;
- bilateral interstitial pneumonia at CT scan;
- hypoxemic respiratory failure defined as PaO2/FiO2 < 200 at blood gas analyses.
Key exclusion criteria (4 listed)
- type 2 respiratory failure;
- hemodynamic instability requiring vasopressors and/or inotropes support;
- CT evidence of pneumothorax/pneumomediastinum;
- concomitant acute medical disease (stroke; myocardial infarction; septic shock; gastrointestinal bleeding; acute renal failure requiring dialysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP Standard ProtocolAll the patients treated with CPAP receive a PEEP standard of 10 cmH2O with a fixed FiO2 | Other | Group A, Group B |
Primary outcome
Primary outcome
Time frame: From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.
composite of hospital mortality and need of endotracheal intubation
1 secondary outcome
Secondary outcome
Time frame: From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Results publication: PubMed 33011929Bosso G, Allegorico E, Pagano A, Porta G, Serra C, Minerva V, Mercurio V, Russo T, Altruda C, Arbo P, De Sio C, Dello Vicario F, Numis FG. Lung ultrasound as diagnostic tool for SARS-CoV-2 infection. Intern Emerg Med. 2021 Mar;16(2):471-476. doi: 10.1007/s11739-020-02512-y. Epub 2020 Oct 3.
- Results publication: PubMed 32629100Pagano A, Porta G, Bosso G, Allegorico E, Serra C, Dello Vicario F, Minerva V, Russo T, Altruda C, Arbo P, Mercurio V, Numis FG. Non-invasive CPAP in mild and moderate ARDS secondary to SARS-CoV-2. Respir Physiol Neurobiol. 2020 Sep;280:103489. doi: 10.1016/j.resp.2020.103489. Epub 2020 Jul 3.
- Results publication: PubMed 29404202Paolini V, Faverio P, Aliberti S, Messinesi G, Foti G, Sibila O, Monzani A, De Giacomi F, Stainer A, Pesci A. Positive end expiratory pressure in acute hypoxemic respiratory failure due to community acquired pneumonia: do we need a personalized approach? PeerJ. 2018 Jan 30;6:e4211. doi: 10.7717/peerj.4211. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio G Numis, MD study chair
Santa Maria delle Grazie Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP Standard Protocol in people with COVID-19 Acute Respiratory Distress Syndrome, run by Santa Maria delle Grazie Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05178160, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.