Dataset Information

ELMO, a new helmet interface for CPAP to treat COVID-19-related acute hypoxemic respiratory failure outside the ICU: a feasibility study.

ABSTRACT:

Objective

To assess the feasibility of using a new helmet interface for CPAP, designated ELMO, to treat COVID-19-related acute hypoxemic respiratory failure (AHRF) outside the ICU.

Methods

This was a proof-of-concept study involving patients with moderate to severe AHRF secondary to COVID-19 admitted to the general ward of a public hospital. The intervention consisted of applying CPAP via the ELMO interface integrated with oxygen and compressed air flow meters (30 L/min each) and a PEEP valve (CPAP levels = 8-10 cmH2O), forming the ELMOcpap system. The patients were monitored for cardiorespiratory parameters, adverse events, and comfort.

Results

Ten patients completed the study protocol. The ELMOcpap system was well tolerated, with no relevant adverse effects. Its use was feasible outside the ICU for a prolonged amount of time and was shown to be successful in 60% of the patients. A CPAP of 10 cmH2O with a total gas flow of 56-60 L/min improved oxygenation after 30-to 60-min ELMOcpap sessions, allowing a significant decrease in estimated FIO2 (p = 0.014) and an increase in estimated PaO2/FIO2 ratio (p = 0.008) within the first hour without CO2 rebreathing.

Conclusions

The use of ELMOcpap has proven to be feasible and effective in delivering high-flow CPAP to patients with COVID-19-related AHRF outside the ICU. There were no major adverse effects, and ELMO was considered comfortable. ELMOcpap sessions significantly improved oxygenation, reducing FIO2 without CO2 rebreathing. The overall success rate was 60% in this pilot study, and further clinical trials should be carried out in the future.(ClinicalTrials.gov identifier: NCT04470258 [http://www.clinicaltrials.gov/]).

SUBMITTER: Tomaz BS

PROVIDER: S-EPMC8836630 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

ELMO, a new helmet interface for CPAP to treat COVID-19-related acute hypoxemic respiratory failure outside the ICU: a feasibility study.

Tomaz Betina Santos BS Gomes Gabriela Carvalho GC Lino Juliana Arcanjo JA Menezes David Guabiraba Abitbol de DGA Soares Jorge Barbosa JB Furtado Vasco V Soares Júnior Luiz L Farias Maria do Socorro Quintino MDSQ Lima Debora Lilian Nascimento DLN Pereira Eanes Delgado Barros EDB Holanda Marcelo Alcantara MA

Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia 20220202 1

<h4>Objective</h4>To assess the feasibility of using a new helmet interface for CPAP, designated ELMO, to treat COVID-19-related acute hypoxemic respiratory failure (AHRF) outside the ICU.<h4>Methods</h4>This was a proof-of-concept study involving patients with moderate to severe AHRF secondary to COVID-19 admitted to the general ward of a public hospital. The intervention consisted of applying CPAP via the ELMO interface integrated with oxygen and compressed air flow meters (30 L/min each) and ...[more]

PMID: 35137871

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Project description:BackgroundRespiratory failure due to COVID-19 pneumonia is associated with high mortality and may overwhelm health care systems, due to the surge of patients requiring advanced respiratory support. Shortage of intensive care unit (ICU) beds required many patients to be treated outside the ICU despite severe gas exchange impairment. Helmet is an effective interface to provide continuous positive airway pressure (CPAP) noninvasively. We report data about the usefulness of helmet CPAP during pandemic, either as treatment, a bridge to intubation or a rescue therapy for patients with care limitations (DNI).MethodsIn this observational study we collected data regarding patients failing standard oxygen therapy (i.e., non-rebreathing mask) due to COVID-19 pneumonia treated with a free flow helmet CPAP system. Patients' data were recorded before, at initiation of CPAP treatment and once a day, thereafter. CPAP failure was defined as a composite outcome of intubation or death.ResultsA total of 306 patients were included; 42% were deemed as DNI. Helmet CPAP treatment was successful in 69% of the full treatment and 28% of the DNI patients (P < 0.001). With helmet CPAP, PaO2/FiO2 ratio doubled from about 100 to 200 mmHg (P < 0.001); respiratory rate decreased from 28 [22-32] to 24 [20-29] breaths per minute, P < 0.001). C-reactive protein, time to oxygen mask failure, age, PaO2/FiO2 during CPAP, number of comorbidities were independently associated with CPAP failure. Helmet CPAP was maintained for 6 [3-9] days, almost continuously during the first two days. None of the full treatment patients died before intubation in the wards.ConclusionsHelmet CPAP treatment is feasible for several days outside the ICU, despite persistent impairment in gas exchange. It was used, without escalating to intubation, in the majority of full treatment patients after standard oxygen therapy failed. DNI patients could benefit from helmet CPAP as rescue therapy to improve survival.Trial registrationNCT04424992.

Project description:ImportanceHelmet noninvasive ventilation has been used in patients with COVID-19 with the premise that helmet interface is more effective than mask interface in delivering prolonged treatments with high positive airway pressure, but data about its effectiveness are limited.ObjectiveTo evaluate whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.Design, setting, and participantsThis was a multicenter, pragmatic, randomized clinical trial that was conducted in 8 sites in Saudi Arabia and Kuwait between February 8, 2021, and November 16, 2021. Adult patients with acute hypoxemic respiratory failure (n = 320) due to suspected or confirmed COVID-19 were included. The final follow-up date for the primary outcome was December 14, 2021.InterventionsPatients were randomized to receive helmet noninvasive ventilation (n = 159) or usual respiratory support (n = 161), which included mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen.Main outcomes and measuresThe primary outcome was 28-day all-cause mortality. There were 12 prespecified secondary outcomes, including endotracheal intubation, barotrauma, skin pressure injury, and serious adverse events.ResultsAmong 322 patients who were randomized, 320 were included in the primary analysis, all of whom completed the trial. Median age was 58 years, and 187 were men (58.4%). Within 28 days, 43 of 159 patients (27.0%) died in the helmet noninvasive ventilation group compared with 42 of 161 (26.1%) in the usual respiratory support group (risk difference, 1.0% [95% CI, -8.7% to 10.6%]; relative risk, 1.04 [95% CI, 0.72-1.49]; P = .85). Within 28 days, 75 of 159 patients (47.2%) required endotracheal intubation in the helmet noninvasive ventilation group compared with 81 of 161 (50.3%) in the usual respiratory support group (risk difference, -3.1% [95% CI, -14.1% to 7.8%]; relative risk, 0.94 [95% CI, 0.75-1.17]). There were no significant differences between the 2 groups in any of the prespecified secondary end points. Barotrauma occurred in 30 of 159 patients (18.9%) in the helmet noninvasive ventilation group and 25 of 161 (15.5%) in the usual respiratory support group. Skin pressure injury occurred in 5 of 159 patients (3.1%) in the helmet noninvasive ventilation group and 10 of 161 (6.2%) in the usual respiratory support group. There were 2 serious adverse events in the helmet noninvasive ventilation group and 1 in the usual respiratory support group.Conclusions and relevanceResults of this study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. However, interpretation of the findings is limited by imprecision in the effect estimate, which does not exclude potentially clinically important benefit or harm.Trial registrationClinicalTrials.gov Identifier: NCT04477668.

Project description:BackgroundInhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of neonatal hypoxemic respiratory failure (NHRF). However, there is lack of sustained improvement in 30 to 46% of infants. Aerosolized prostaglandins I2 (PGI2) and E1 (PGE1) have been reported to be effective selective pulmonary vasodilators. The objective of this study was to evaluate the feasibility of a randomized controlled trial (RCT) of inhaled PGE1 (IPGE1) in NHRF.MethodsTwo pilot multicenter phase II RCTs are included in this report. In the first pilot, late preterm and term neonates with NHRF, who had an oxygenation index (OI) of ≥15 and <25 on two arterial blood gases and had not previously received INO, were randomly assigned to receive two doses of IPGE1 (300 and 150 ng/kg/min) or placebo. The primary outcome was the enrollment of 50 infants in six to nine months at 10 sites. The first pilot was halted after four months for failure to enroll a single infant. The most common cause for non-enrollment was prior initiation of INO. In a re-designed second pilot, co-administration of IPGE1 and INO was permitted. Infants with suboptimal response to INO received either aerosolized saline or IPGE1 at a low (150 ng/kg/min) or high dose (300 ng/kg/min) for a maximum duration of 72 hours. The primary outcome was the recruitment of an adequate number of patients (n = 50) in a nine-month-period, with fewer than 20% protocol violations.ResultsNo infants were enrolled in the first pilot. Seven patients were enrolled in the second pilot; three in the control, two in the low-dose IPGE1, and two in the high-dose IPGE1 groups. The study was halted for recruitment futility after approximately six months as enrollment targets were not met. No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported.ConclusionsThese two pilot RCTs failed to recruit adequate eligible newborns with NHRF. Complex management RCTs of novel therapies for persistent pulmonary hypertension of the newborn (PPHN) may require novel study designs and a longer period of time from study approval to commencement of enrollment.Trial registrationCLINICALTRIALS.GOV: Pilot one: NCT number: 00598429 registered on 10 January 2008. Last updated: 3 February 2011. Pilot two: NCT number: 01467076 17 October 2011. Last updated: 13 February 2013.

Project description:Rationale: The respective effects of positive end-expiratory pressure (PEEP) and pressure support delivered through the helmet interface in patients with hypoxemia need to be better understood. Objectives: To assess the respective effects of helmet pressure support (noninvasive ventilation [NIV]) and continuous positive airway pressure (CPAP) compared with high-flow nasal oxygen (HFNO) on effort to breathe, lung inflation, and gas exchange in patients with hypoxemia (PaO2/FiO2 ⩽ 200). Methods: Fifteen patients underwent 1-hour phases (constant FiO2) of HFNO (60 L/min), helmet NIV (PEEP = 14 cm H2O, pressure support = 12 cm H2O), and CPAP (PEEP = 14 cm H2O) in randomized sequence. Measurements and Main Results: Inspiratory esophageal (ΔPES) and transpulmonary pressure (ΔPL) swings were used as surrogates for inspiratory effort and lung distension, respectively. Tidal Volume (Vt) and end-expiratory lung volume were assessed with electrical impedance tomography. ΔPES was lower during NIV versus CPAP and HFNO (median [interquartile range], 5 [3-9] cm H2O vs. 13 [10-19] cm H2O vs. 10 [8-13] cm H2O; P = 0.001 and P = 0.01). ΔPL was not statistically different between treatments. PaO2/FiO2 ratio was significantly higher during NIV and CPAP versus HFNO (166 [136-215] and 175 [158-281] vs. 120 [107-149]; P = 0.002 and P = 0.001). NIV and CPAP similarly increased Vt versus HFNO (mean change, 70% [95% confidence interval (CI), 17-122%], P = 0.02; 93% [95% CI, 30-155%], P = 0.002) and end-expiratory lung volume (mean change, 198% [95% CI, 67-330%], P = 0.001; 263% [95% CI, 121-407%], P = 0.001), mostly due to increased aeration/ventilation in dorsal lung regions. During HFNO, 14 of 15 patients had pendelluft involving >10% of Vt; pendelluft was mitigated by CPAP and further by NIV. Conclusions: Compared with HFNO, helmet NIV, but not CPAP, reduced ΔPES. CPAP and NIV similarly increased oxygenation, end-expiratory lung volume, and Vt, without affecting ΔPL. NIV, and to a lesser extent CPAP, mitigated pendelluft. Clinical trial registered with clinicaltrials.gov (NCT04241861).

Project description:Driving pressure (DP) is a marker of severity of lung injury in patients with acute respiratory distress syndrome (ARDS) and has a strong association with outcome. However, it is uncertain whether limiting DP can reduce the mortality of patients with acute hypoxemic respiratory failure (AHRF). Therefore, this study aimed to determine the correlation between the initial DP setting and the clinical outcomes of patients with AHRF upon their initial admission to the intensive care unit (ICU). The Medical Information Mart for Intensive Care IV (MIMIC-IV) database was used to search the data of patients with AHRF, with 180-day mortality representing the primary outcome. Multiple regression analysis was subsequently performed to evaluate the initial DP and 180-day mortality association. The reliability of the results was validated using restricted cubic splines and interaction studies. This study retrospectively analyzed data from 907 patients-581 (64.06%) in the survival group and 326 (35.94%) in the nonsurvival group (NSG)-who were followed up 180 days after admission. The results revealed that an elevated initial DP was significantly correlated with 180-day mortality (HR 1.071 (95% CI 1.040, 1.102)), especially when the initial DP exceeded 12 cmH2O. AHRF patients with an initial DP > 12 cmH2O had significantly greater mortality at 28 days (p = 0.0082), 90 days (p = 0.0083), and 180 days (p = 0.0039) than those with an initial DP ≤ 12 cmH2O. Among severe patients with AHRF, 180-day mortality was significantly greater in the group with an initial DP > 12 cmH2O than in the group with an initial DP ≤ 12 cmH2O (p = 0.029). The hospital length of stay (LOS) for patients with an initial DP < 12 cmH2O was significantly longer than that for those with an initial DP > 12 cmH2O (p = 0.029). Among patients with AHRF and an initial DP > 12 cmH2O, the survival group had a significantly longer LOS in the ICU than the NSG (p = 0.00026). The initial DP settings were correlated with 180-day mortality among patients with AHRF admitted to the ICU. Particularly for patients with AHRF, it is crucial to consider implementing early restrictive DP ventilation as a potential means to mitigate mortality, and close monitoring is essential to evaluate its impact.

Dataset Information

ELMO, a new helmet interface for CPAP to treat COVID-19-related acute hypoxemic respiratory failure outside the ICU: a feasibility study.

Objective

Methods

Results

Conclusions

Publications

ELMO, a new helmet interface for CPAP to treat COVID-19-related acute hypoxemic respiratory failure outside the ICU: a feasibility study.

Similar Datasets

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