Efficacy of Dexamethasone in Preventing Acute Mountain Sickness in COPD Patients

Furian, Michael; Lichtblau, Mona; Aeschbacher, Sayaka S.; Estebesova, Bermet; Emilov, Berik; Sheraliev, Ulan; Marazhapov, Nuriddin H.; Mademilov, Maamed; Osmonov, Batyr; Bisang, Maya; Ulrich, Stefanie; Latshang, Tsogyal D.; Ulrich, Silvia; Sooronbaev, Talant; Bloch, Konrad E.

doi:10.1016/j.chest.2018.06.006

Cited by 20 publications

(25 citation statements)

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“…The relevance of the improvement in hypoxemia by dexamethasone is uncertain as the minimal clinically important degree of alleviation of hypoxemia is unknown and symptoms of AMS were not reduced. 12 However, it is generally accepted that the health risks of hypoxemia increase with its severity, in particular, in patients with cardiopulmonary disease, such as the participants in the present study. Air travel recommendations suggest that patients with stable respiratory disease reaching a Sp o 2 lower than 85% during a normobaric hypoxic challenge test (breathing 15% fractional inspired oxygen for 20 minutes) use in-flight oxygen.…”

Section: Discussionmentioning

confidence: 78%

“…Sample size estimation based on the trial evaluating effects of dexamethasone on AMS indicated a minimal number of 100 participants. 12 The present trial was powered with 80% to detect a mean (SD) minimal difference in Sp o 2 (primary outcome) of 2% (3.5%) 5 and, in AHI, an important secondary outcome, of 10 (17) events/h, with a 2-sided significance level of α = .05.…”

Section: Methodsmentioning

confidence: 99%

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Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters

et al. 2019

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Key Points Question Does preventive dexamethasone treatment mitigate altitude-related nocturnal hypoxemia in lowlanders with chronic obstructive pulmonary disease traveling to a high altitude? Findings In this randomized clinical trial of 118 patients with chronic obstructive pulmonary disease who lived below 800 m, dexamethasone, 4 mg, orally twice daily, starting 24 hours before ascent and while staying in a clinic at 3100 m, significantly mitigated the altitude-induced decrease in mean arterial oxygen saturation during 2 nights at 3100 m by 2% to 3%. In addition, dexamethasone therapy prevented emergence of central sleep apnea and improved subjective sleep quality. Meaning Patients with chronic obstructive pulmonary disease traveling to a high altitude may benefit from preventive dexamethasone treatment in terms of nocturnal oxygenation and sleep quality.

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Section: Discussionmentioning

confidence: 78%

Section: Methodsmentioning

confidence: 99%

Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters

et al. 2019

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“…The current study was performed from June to August 2015 within the scope of a randomized, placebo controlled double blind parallel design trial evaluating effectiveness of dexamethasone in prevention of altitude-related adverse health effects (ARAHE) in lowlanders with COPD traveling to and staying for 2 days at the high altitude (3100 m) clinic of Tuja-Ashu, Kyrgyztan (clinicaltrials.gov Identifier: NCT02450968). The effects of altitude and of dexamethasone on AMS and various other clinical and physiologic outcomes have been reported recently ( Furian et al, 2018 ).…”

Section: Methodsmentioning

confidence: 99%

“…Since the minimal important difference for COPL and other indices of PC has not been established we based the sample size estimation for this study on previous studies in 51 healthy individuals who showed a significant change in indices of PC measured by the Wii balance board at 2590 m ( Stadelmann et al, 2015 ). In addition, a sample size estimation was performed for the primary outcome of the main trial associated with the current study, the cumulative incidence of ARAHE during the stay at 3100 m. According to these calculations, a minimal number of 100 participants including drop-outs were required to detect a 50% reduction in ARAHE by dexamethasone ( Furian et al, 2018 ).…”

Section: Methodsmentioning

confidence: 99%

Postural Control in Lowlanders With COPD Traveling to 3100 m: Data From a Randomized Trial Evaluating the Effect of Preventive Dexamethasone Treatment

et al. 2018

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Objective: To evaluate the effects of acute exposure to high altitude and preventive dexamethasone treatment on postural control in patients with chronic obstructive pulmonary disease (COPD).Methods: In this randomized, double-blind parallel-group trial, 104 lowlanders with COPD GOLD 1-2 age 20–75 years, living near Bishkek (760 m), were randomized to receive either dexamethasone (2 × 4 mg/day p.o.) or placebo on the day before ascent and during a 2-day sojourn at Tuja-Ashu high altitude clinic (3100 m), Kyrgyzstan. Postural control was assessed with a Wii Balance BoardTM at 760 m and 1 day after arrival at 3100 m. Patients were instructed to stand immobile on both legs with eyes open during five tests of 30 s each, while the center of pressure path length (PL) was measured.Results: With ascent from 760 to 3100 m the PL increased in the placebo group from median (quartiles) 29.2 (25.8; 38.2) to 31.5 (27.3; 39.3) cm (P < 0.05); in the dexamethasone group the corresponding increase from 28.8 (22.8; 34.5) to 29.9 (25.2; 37.0) cm was not significant (P = 0.10). The mean difference (95% CI) between dexamethasone and placebo groups in altitude-induced changes (treatment effect) was -0.3 (-3.2 to 2.5) cm, (P = 0.41). Multivariable regression analysis confirmed a significant increase in PL with higher altitude (coefficient 1.6, 95% CI 0.2 to 3.1, P = 0.031) but no effect of dexamethasone was shown (coefficient -0.2, 95% CI -0.4 to 3.6, P = 0.925), even when controlled for several potential confounders. PL changes were related more to antero-posterior than lateral sway. Twenty-two of 104 patients had an altitude-related increase in the antero-posterior sway velocity of >25%, what has been associated with an increased risk of falls in previous studies.Conclusion: Lowlanders with COPD travelling from 760 to 3100 m revealed postural instability 24 h after arriving at high altitude, and this was not prevented by dexamethasone.Trial Registration: clinicaltrials.gov Identifier: NCT02450968.

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“…The medical literature contains a multitude of examples of RCTs across many disease and intervention types. Some examples of recent twoarm randomized controlled trials published in CHEST are presented in Table 1 [11][12][13][14][15] to demonstrate various applications of RCTs, although these examples are not exhaustive.…”

Section: Use Cases Of Study Designmentioning

confidence: 99%

Randomized Controlled Trials

Zabor

Kaizer

Hobbs

2020

Chest

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Randomized controlled trials (RCTs) are considered the highest level of evidence to establish causal associations in clinical research. There are many RCT designs and features that can be selected to address a research hypothesis. Designs of RCTs have become increasingly diverse as new methods have been proposed to evaluate increasingly complex scientific hypotheses.This article reviews the principles and general concepts behind many common RCT designs and introduces newer designs that have been proposed, such as adaptive and cluster randomized trials. A focus on the many choices for randomization within an RCT is described, along with their potential tradeoffs. To illustrate their diversity, examples of RCTs from the literature are provided. Statistical considerations, such as power and type I error rates, are discussed with the intention of providing practical guidance about how to specify study hypotheses that address the scientific question while being statistically appropriate. Finally, the freely available Consolidated Standards of Reporting Trials guidelines and US Food and Drug Administration guidance documents are introduced, along with a set of guidelines one should consider when planning an RCT or reviewing RCTs submitted for publication in peer-reviewed academic journals.

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Efficacy of Dexamethasone in Preventing Acute Mountain Sickness in COPD Patients

Cited by 20 publications

References 24 publications

Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters

Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters

Postural Control in Lowlanders With COPD Traveling to 3100 m: Data From a Randomized Trial Evaluating the Effect of Preventive Dexamethasone Treatment

Randomized Controlled Trials

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