High flow oxygen for dyspnea in hospitalized patients with cancer: A 4x4 crossover randomized clinical trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12077-12077
Author(s):  
David Hui ◽  
Farley Hernandez ◽  
Saji Thomas ◽  
Zhanni Lu ◽  
Ahmed F. Elsayem ◽  
...  

12077 Background: Dyspnea is common in hospitalized cancer patients and highly distressing. High flow oxygen (HFOx) is administered for oxygenation in this setting; however, its effect on dyspnea has not been well examined, particularly among non-hypoxemic patients. In this phase II trial, we assessed the effect of HFOx, high flow air (HFAir), low flow oxygen (LFOx) and low flow air (LFAir) on dyspnea. We hypothesized that HFO and HFA can alleviate dyspnea. Methods: This double-blind, 4x4 crossover clinical trial enrolled hospitalized patients with cancer who were dyspneic (NRS ≥3 at rest) and non-hypoxemic (SpO2>90% on room air). Patients were randomized to 10 minutes of HFOx, HFAir, LFOx and LFAir in different orders. The flow rate was titrated between 20-60 L/min in the high flow groups and 2 L/min in the low flow groups. The primary outcome was dyspnea 0-10 numeric rating scale (NRS) “now”, where 0=none and 10=worst. Secondary outcomes included modified Borg scale dyspnea intensity and unpleasantness, adverse effects, and overall preference. We compared among the interventions with a linear mixed model adjusting for time, treatment effect, period effect and carryover effect. Results: 17 patients completed 55 interventions in a random order. Mean age 51, 58% female, mean baseline dyspnea NRS 6.3 (SD 1.7). The absolute change of dyspnea NRS between 0 and 10 minutes was -1.8 (SD 1.7) for HFOx, -1.8 (2.0) for HFAir, -0.5 (0.8) for LFOx and -0.6 (1.2) for LFAir. In mixed model analysis, HFOx group provided greater dyspnea relief than LFOx (mean difference [95% CI] -0.80 [-1.45, -0.15], P=0.02) and LFAir (-1.24 [-1.90, -0.57], P<0.001). HFAir also provided a significantly greater dyspnea relief than LFOx (-0.95 [-1.61, -0.30], P=0.005) and LFAir (-1.39 [-2.05, -0.73], P<0.001). No difference was found between HFOx and HFAir nor between LFOx and LFAir. There was no significant carryover effect. Dyspnea Borg scale intensity and unpleasantness showed similar changes. Oxygen saturation increased in the HFOx group (97.2% to 99.7%) and LFOx group (95.5% to 98.2%) but not HFAir nor LFAir groups. HFOx was well tolerated. At the end of the study, 7 (54%), 4 (31%), 1 (8%) and 1 (8%) patients blindly preferred HFOx, HFAir, LFOx and LFAir, respectively. Conclusions: For the first time, we found that HFOx and HFAir provided a rapid and clinically significant reduction of dyspnea at rest in hospitalized cancer patients even when they were non-hypoxemic, supporting a role for high flow devices to provide palliation beyond oxygenation. Larger studies are needed to confirm these findings. Clinical trial information: NCT02932332 .

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11600-11600
Author(s):  
David Hui ◽  
Liliana Larsson ◽  
Sajan Thomas ◽  
Carol Harrison ◽  
Jimin Wu ◽  
...  

11600 Background: High flow oxygen therapy is effective for hypoxemic respiratory failure. However, its effect on dyspnea in non-hypoxemic patients is unknown. In this 2x2 factorial, double-blind randomized clinical trial, we assessed the effect of flow rate (high vs. low) and gas (oxygen vs. air) on exertional dyspnea in cancer patients. Methods: Non-hypoxemic patients with cancer completed two structured cycle ergometer exercise tests with Low Flow Air [LFAir] at 2 L/min. They were then randomized to receive High Flow Oxygen [HFOx] with up to 60 L/min, High Flow Air [HFAir], Low Flow Oxygen [LFOx] or LFAir during a constant work rate exercise test at 80% maximum. Dyspnea intensity was assessed with the modified 0-10 Borg scale. The primary outcome was difference in the slope of dyspnea intensity vs. time during the third test. Secondary outcomes included difference in exercise time, vital signs, and adverse events. We estimated that 10 patients per arm will provide 86% power to detect a 1-standard deviation main effect and 86% power to detect a 2-SD interaction effect with an alpha of 5%. A linear mixed effects model was used to assess the impact of flow rate and gas on study outcomes. Results: 45 patients were randomized and 44 completed the study (10, 11, 12, 11 patients on HFOx, HFAir, LFOx, LFAir, respectively). The mean age was 63 (range 47-77); 18 (41%) were female; 34 (44%) had lung cancer; and 20 (46%) had metastatic disease. In mixed effects model, the association between the change in dyspnea intensity over time with flow rate differed significantly between oxygen and air (P = 0.04). Specifically, HFOx (slope difference -0.20, P < 0.001) and LFOx (-0.14, P = 0.01) were significantly better than LFAir, but not HFAir (+0.09, P = 0.09). Exercise time also significantly increased with HFOx (difference +2.5 min, P = 0.009) compared to LFAir, but not HFAir (+0.63 min, P = 0.48) or LFOx (+0.39 min, P = 0.65). HFOx was well tolerated without significant adverse effects. Conclusions: The combination of high flow rate and oxygen improved dyspnea and exercise duration during constant work exercise test in non-hypoxemic cancer patients. Larger trials are needed to confirm the benefits of HFOx during exercises. Clinical trial information: NCT02357134.


2021 ◽  
Author(s):  
Guillaume Béraud ◽  
Jean-François Timsit ◽  
Henri Leleu

AbstractRemdesivir and dexamethasone are the only drugs providing reductions in the lengths of hospital stays for COVID-19 patients. We assessed the impacts of remdesivir on hospital-bed resources and budgets affected by the COVID-19 outbreak. A stochastic agent-based model was combined with epidemiological data available on the COVID-19 outbreak in France and data from two randomized control trials. Strategies involving treating with remdesivir only patients with low-flow oxygen and patients with low-flow and high-flow oxygen were examined. Treating all eligible low-flow oxygen patients during the entirety of the second wave would have decreased hospital-bed occupancy in conventional wards by 4% [2%; 7%] and intensive care unit (ICU)-bed occupancy by 9% [6%; 13%]. Extending remdesivir use to high-flow-oxygen patients would have amplified reductions in ICU-bed occupancy by up to 14% [18%; 11%]. A minimum remdesivir uptake of 20% was required to observe decreases in bed occupancy. Dexamethasone had effects of similar amplitude. Depending on the treatment strategy, using remdesivir would, in most cases, generate savings (up to 722€) or at least be cost neutral (an extra cost of 34€). Treating eligible patients could significantly limit the saturation of hospital capacities, particularly in ICUs. The generated savings would exceed the costs of medications.


Author(s):  
Edit Nadasi ◽  
Gellert Cseh

In cancer, more than 30% of patients die due to cachexia and more than 50% of patients with cancer die with cachexia being present. Patients with cancer cachexia frequently develop a chronic negative energy and protein balance driven by a combination of reduced food intake and metabolic change. Several studies have already demonstrated the usefulness of oral nutritional supplements (ONS) in managing malnutrition of cancer patients. Though increased energy intake is very important in managing cancer-related malnutrition, the source of this extra energy and the presence of anti-inflammatory and immunonutritional components may also play an important role. Here we present the study protocol of a randomized, open-label, multicentre clinical trial aimed to determine whether an ONS composed according to the needs of patients with malignant diseases an ONS composed according to the needs of patients with malignant diseases is more effective than a general product in improving the nutritional status in cancer patients.


BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037964
Author(s):  
Shahan Waheed ◽  
Nazir Najeeb Kapadia ◽  
Muhammad Faisal Khan ◽  
Salima Mansoor Kerai ◽  
Ahmed Raheem ◽  
...  

IntroductionApnoeic oxygenation is a process of delivering continuous oxygen through nasal cannula during direct laryngoscopy. The oxygen that is delivered through these nasal cannulas is either low flow or high flow. Although the effectiveness of apnoeic oxygenation has been shown through systematic reviews and randomised controlled trials, a comparison of high-flow versus low-flow oxygen delivery has not been tested through a superiority study design. In this study we propose to assess the effectiveness of giving low-flow oxygen with head side elevation versus high-flow oxygen with head side elevation against the usual practice of care in which no oxygen is provided during direct laryngoscopy.Methods and analysisThis will be a three-arm study instituting a block randomisation technique with a sample size of 46 in each arm (see table 1). Due to the nature of the intervention, no blinding will be introduced. The primary outcomes will be lowest non-invasive oxygen saturation measurement during direct laryngoscopy and during the 2 min after the placement of the tube and the first pass success rate. The intervention constitutes head side elevation up to 30° for improving glottis visualisation together with low-flow or high-flow oxygen delivery through nasal cannula to increase safe apnoea time for participants undergoing endotracheal intubation. Primary analysis will be intention to treat.Ethics and disseminationThe study is approved by the Ethical Review Committee of Aga Khan University Hospital (2019-0726-2463). The project is an institution University Research Committee grant recipient 192 002ER-PK. The results of the study will be disseminated among participants, patient communities and healthcare professionals in the institution through seminars, presentations and emails. Further, the findings will be published in a highly accessed peer-reviewed medical journal and will be presented at both national and international conferences.Trial registration numberClinicalTrials.gov Registry (NCT04242537).


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3020-3020
Author(s):  
Lauren Elreda ◽  
Reena K Vora ◽  
Alice J. Cohen

Abstract Background: Venous thromboembolism (VTE) remains a major cause of morbidity and mortality in hospitalized patients with cancer. In 2007, both ASCO and the NCCN developed clinical practice guidelines to help prevent and treat thrombosis in patients with cancer. Adherence to these guidelines has led to successful reduction of VTE in hospitalized patients. Because noncompliance with anticoagulant prophylaxis was an ongoing problem at our institution, a standardized order set for thromboprophylaxis (TP) utilizing anticoagulant therapy was developed and implemented for patients with cancer diagnoses. Methods: All patients admitted to the inpatient oncology unit with a cancer diagnosis were screened for VTE prophylaxis utilizing a standardized order set. Cancer diagnosis and other risk factors for VTE were recorded on the TP order set along with choice of anticoagulant TP. Treatment options included Lovenox 40 mg once subcutaneous (sc)daily for patients with normal renal function, lovenox 30 mg sc daily for creatinine clearance &lt;30cc/min, heparin(h) 5000 units sc every 8 hours. Pneumatic compression devices were utilized in patients who had contraindications to anticoagulation. Exclusion criteria included patients already on therapeutic anticoagulation, active bleeding, and platelet count (plt) &lt;50,000. TP was instituted upon admission and continued until discharge. Patients were clinically monitored for VTE for 4 weeks post discharge and if symptomatic, venous Dopplers, VQ and/or Spiral CT scans were performed. Retrospective review of all VTE events in hospitalized cancer patients occurring in the previous quarter prior to initiation of the standardized order set was performed and number of VTE events and length of stay (LOS) were compared to the treatment group. Results: 100 cancer patients were admitted to the inpatient oncology unit from 4/08–7/08 with use of the standardized TP order set for all patients. 89 patients received TP as follows: 79 received lovenox 40 mg sc daily, 2 lovenox 30mg sc daily, 5 h 5000 units sc q 8 hours, and 3 flowtron boots. 11 patients did not receive TP for the following reasons: 6 were on therapeutic anticoagulation for previous VTE, 4 had a plt &lt; 50,000, 1 had brain metastases with surrounding edema. Of those who did receive TP, no VTE occurred during hospitalization and for 1 month post discharge. No bleeding complications were seen. As compared to those patients treated with the TP order set, 20/207 (9.6%) non-surgical hospitalized patients with cancer developed VTE during their hospitalization in the previous quarter (p&lt;0.01). Of these patients, 11 did not receive TP, and 9 patients received TP: 5 with flowtron boots, 2 short term TP lovenox which was discontinued prematurely, 2 h 5000 units sc 8 hours. The average LOS of patients managed utilizing the TP order set was 7.1 days compared to 19.0 days (p&lt;0.0001) in hospitalized cancer patients with VTE events prior to use of the TP order set. Conclusion: Hospitalized cancer patients are at significant risk for the development of VTE. The implementation of a standard order set ensures compliance with TP and significantly reduces VTE events. LOS is significantly reduced in hospitalized cancer patients by preventing VTE.


Author(s):  
Sarita Thawanaphong ◽  
Wasuwat Kitisomprayoonkul ◽  
Kannit Pongpipatpaiboon ◽  
Napplika Kongpolprom

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19563-19563
Author(s):  
P. Thapaliya ◽  
A. Donato ◽  
K. Curl

19563 Background: Clostridium difficle infection is a major cause of morbidity and mortality in hospitalized patients. The recent use of cancer chemotherapy agents is a frequently cited risk factor but there is a paucity of evidence to this regard. Objective: To determine if an association exists between C. difficile infection requiring hospitalization and recent chemotherapy in patients with cancer. Design: A retrospective case control study. Setting: Community Teaching Hospital Participants: 357 cancer patients admitted with diarrhea or developed diarrhea during their hospital stay that were tested for C. difficile diarrhea via toxin assay over a 2 year period. Outcome Measurements: C. difficile infection using tests for toxin A and or B in stool. Results: Eighty-nine cases had stool positive for C. difficile toxin whereas 267 controls were negative. 30/89 (33%) cases and 90/268 (33%) controls were found to have chemotherapy in the six weeks before collection of stool for toxin assay (Odds Ratio (OR) 1.09, p=1.0 using Pearson Chi square). Factors associated with infection on logistic regression analysis included recent antibiotic usage (OR 1.99, 95% CI 1.01- 3.93),hospitalization in preceding 2 wks with OR 4.1 (95%CI 2.39–7.05) and institutionalization with OR 2.13 (95 % CI 1.03–4.39). Conclusions: C .difficile infection in cancer patients is more likely in recently institutionalized or hospitalized patients who have received recent antibiotics, but not patients with recent chemotherapy. No significant financial relationships to disclose.


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