Retrospective analysis of telematic glaucoma clinic as a consequence of COVID-19 pandemic (preprint)

PURPOSE Due to COVID-19 pandemic, the glaucoma clinic had to adapt to meet the needs of this chronic disease. New technologies allowed us to monitor some of these patients in a telematic way.  METHODS We retrospectively analyzed patients with-open angle glaucoma who were visited between September 2021 and March 2022, and compared Visual Field (VF) and Optical Coherence Tomography (OCT) parameters depending on whether they had telematic or only face-to-face controls. All patients were stratified in each group according to glaucoma severity.  RESULTS A total of 204 eyes from 118 patients were included in the analysis, with 100 in the group with only face-to-face controls (group 1/FTF) and 104 with some telematic control (group 2/HG). In group 2/HG, an average of 3.37 face-to-face visits and 1.27 telematic visits were made, while group 1/FTF had 4.4 face-to-face visits. There was no significant difference between the pre-pandemic and 2 years after it visits, neither in Visual Accuity, OCT and VF parameters. Regarding glaucoma severity, there were more cases of severe glaucoma in group 1/FTF and more cases of mild glaucoma in group 2/HG.  CONCLUSIONS Telematic management of the glaucoma clinic, with the use of appropriate tools, can be useful for maintaining the quality of care during periods of face-to-face consultations saturation or when face-to-face control is completely impossible.

High flow nasal oxygen in patients with COVID-19 associated acute respiratory failure (preprint)

Purpose: Whether the use of high-flow nasal oxygen in adult patients with COVID-19 associated acute respiratory failure improves clinically relevant outcomes remains unclear. We thus sought to assess the effect of high-flow nasal oxygen on ventilator-free days, compared to early initiation of invasive mechanical ventilation, on adult patients with COVID-19. Methods: : We conducted a multicentre cohort study using a prospectively collected database of patients with COVID-19 associated acute respiratory failure admitted to 36 Spanish and Andorran intensive care units (ICUs). Main exposure was the use of high-flow nasal oxygen (conservative group), while early invasive mechanical ventilation (within the first day of ICU admission; early intubation group) served as the comparator. The primary outcome was ventilator-free days at 28 days. ICU length of stay and all-cause in-hospital mortality served as secondary outcomes. We used propensity score matching to adjust for measured confounding. Results: : Out of 468 eligible patients, a total of 122 matched patients were included in the present analysis (61 for each group). When compared to early intubation, the use of high-flow nasal oxygen was associated with an increase in ventilator-free days (mean difference: 8.0 days; 95% confidence interval (CI): 4.4 to 11.7 days), and a reduction in ICU length of stay (mean difference: -8.2 days; 95% CI -12.7 to -3.6 days). No difference was observed in all-cause in-hospital mortality between groups (odds ratio: 0.64; 95% CI: 0.25 to 1.64). Conclusions: The use of high-flow nasal oxygen upon ICU admission in adult patients with COVID-19 related acute hypoxemic respiratory failure may lead to an increase in ventilator-free days and a reduction in ICU length of stay, when compared to early initiation of invasive mechanical ventilation. Future studies should confirm our findings.

Incidence of New-Onset Pain, Characteristics and Influence on Health-Related Quality of life in COVID-19 Survivors After Critical Illness. Analysis of the PAIN COVID Clinical Trial cohort. (preprint)

Background: To explore the incidence and characteristics of new-onset pain, its impact on quality of life (HRQoL), and to quantify the presence of mood disorders in critically ill COVID-19 survivors. Methods: This is a preliminary report of PAIN-COVID clinical trial (NCT04394169) presenting a descriptive analysis in critical ill COVID 19 survivors one month after hospital discharge.  Pain was assed using the Brief Pain Inventory short form, Douleur Neuropathique 4 Questions test and Pain Catastrophizing Scale. Health related quality of life (HRQoL) was evaluated with EQoL-5D/5L and mood disorders with Hospital Anxiety and Depression test (HAD).Results: From May 27th to July 19th 2020, 203 patients were consecutively screened for eligibility and 65 were finally included in this analysis. In 33 (50.8%) patients a new-onset pain was reported: 18 (54.5%) reported clinically significant intense pain, 11 (33.3%) a positive screening for neuropathic pain, 3 (9.1%) clinically relevant pain catastrophizing thoughts, 29 (87.9%) pain in ≥2 body sites and 5 (15.2%) widespread pain. Median EQoL-5D/5L index value and visual analogue scale was 0.8 (IQR 0.57-0.87) and 70 (IQR 60-80) respectively. Pain intensity was negatively correlated both to the former (Spearman Rho: -0.546, p<0.001) and to the latter (Spearman Rho: -0.387, p=0.001). A HAD anxiety and depression value over 8 were obtained in 7 (10,8 %) and 5 (7,7%) of patients, respectively.Conclusion: The incidence of new-onset pain in critically ill COVID-19 survivors is high and it was associated with a lower HRQoL. Trial registration: NCT04394169. Registered 19 May 2020. https://clinicaltrials.gov/ct2/show/NCT04394169

Predictors of failure with high-flow nasal oxygen therapy in COVID-19 patients with acute respiratory failure: a multicentre observational study (preprint)

Purpose We aimed to describe the use of high-flow nasal oxygen (HFNO) in patients with COVID-19 acute respiratory failure and factors associated with a shift to invasive mechanical ventilation.Methods This is a multicentre, observational study from a prospectively collected database of consecutive COVID-19 patients admitted to 36 Spanish and Andorran intensive care units (ICUs) who received HFNO on ICU admission during a 22-week period (March 12-August 13, 2020). Outcomes of interest were factors on the day of ICU admission associated with the need for endotracheal intubation. We used multivariable logistic regression and mixed effects models. A predictive model for endotracheal intubation in patients treated with HFNO was derived and internally validated.Results From a total of 259 patients initially treated with HFNO, 140 patients (54%) required invasive mechanical ventilation. Baseline non-respiratory Sequential Organ Failure Assessment (SOFA) score [odds ratio (OR) 1.78; 95% confidence interval (CI) 1.41–2.35], and the ROX index calculated as the ratio of partial pressure of arterial oxygen to inspired oxygen fraction divided by respiratory rate (OR 0.53; 95% CI: 0.37–0.72), and pH (OR 0.47; 95% CI: 0.24–0.86) were associated with intubation. Hospital site explained 1% of the variability in the likelihood of intubation after initial treatment with HFNO. A predictive model including non-respiratory SOFA score and the ROX index showed excellent performance (AUC 0.88, 95%CI 0.80–0.96).Conclusions Among adult critically ill patients with COVID-19 initially treated with HFNO, the SOFA score and the ROX index may help to identify patients with higher likelihood of intubation.

Awake prone positioning does not reduce the risk of intubation in COVID-19 treated with High-Flow Nasal Oxygen therapy. A multicenter, adjusted cohort study (preprint)

Background: Awake prone positioning (awake-PP) in non-intubated coronavirus disease 2019 (COVID-19) patients could avoid endotracheal intubation, reduce the use of critical care resources, and improve survival. We aimed to examine whether the combination of high-flow nasal oxygen therapy (HFNO) with awake-PP prevents the need for intubation when compared to HFNO alone. Methods Prospective, multicentre, adjusted observational cohort study in consecutive COVID-19 patients with acute respiratory failure (ARF) receiving respiratory support with HFNO from 12 March to 9 June, 2020. Patients were classified as HFNO with or without awake-PP. Logistic models were fitted to predict treatment at baseline using the following variables: age, sex, obesity, non-respiratory sequential organ failure assessment score, APACHE-II, C-reactive protein, days from symptoms onset to HFNO initiation, respiratory rate and peripheral oxyhemoglobin saturation. We compared data on demographics, vital signs, laboratory markers, need for invasive mechanical ventilation, days to intubation, ICU length of stay, and ICU mortality between HFNO patients with and without awake-PP. Results A total of 1076 patients with COVID-19 ARF were admitted, of which 199 patients received HFNO and were analyzed. Fifty-five (27.6%) were pronated during HFNO; 60 (41%) and 22 (40%) patients from the HFNO and HFNO+awake-PP groups were intubated. The use of awake-PP as an adjunctive therapy to HFNO did not reduce the risk of intubation [RR 0.87 (95%CI: 0.53–1.43), p=0.60]. Patients treated with HFNO+awake-PP showed a trend for delay in intubation compared to HFNO alone [median 1 (interquartile range, IQR 1.0-2.5) vs 2 IQR 1.0-3.0] days, (p=0.055), but awake-PP did not affect 28-day mortality [RR 1.04 (95%CI: 0.40–2.72), p=0.92]. Conclusion In patients with COVID-19 ARF treated with HFNO, the use of awake-PP did not reduce the need for intubation or affect mortality.

Rationale and Study Design of an Early Care, Therapeutic Education, and Psychological Intervention for the Management of Post-intensive Care Syndrome and Chronic Pain After Coronavirus Disease 2019 (PAIN-COVID): Study protocol for a randomized controlled trial (preprint)

Background: Critically ill patients with COVID-19 disease are an especially susceptible population to develop Post-intensive Care Syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term deterioration in mental, cognitive, and functional health after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and a psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19 disease. The primary objective is to determine if the program is superior to standard-of-care on health-related life quality at six months after hospital discharge. The secondary objectives are to determine if the intervention is superior to standard care, evaluating the health-related life quality, the incidence of chronic pain and the degree of functional limitation, the incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge.Methods: The PAINCOVID trial is a unicentric randomized, controlled, patient blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at six months after hospital discharge, and randomization will be performed with a 1:1 allocation. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available.The sample size calculated is 84 patients, 42 for each arm. Estimating a loss of follow up of 20%, a sample size of 102 patients is necessary (51 each group). Discussion: This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention for the management of PICS and Chronic Pain after COVID-19. The intervention will serve as a sample of the need to implement early care programs on early stages, having an incalculable impact given the current scenario of the pandemic.Trial registration: This study is being in accordance with the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board Comité Ético de Investigación Clínica del Hospital Clinic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020 at  clinicaltrials.gov (NCT04394169).