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Efficacy of non-invasive ventilation and oxygen therapy on immunocompromised patients with acute hypoxaemic respiratory failure: protocol for a systematic review and meta-analysis of randomised controlled trials.

ABSTRACT: BACKGROUND:The number of immunocompromised patients has increased in recent years. Acute respiratory failure is a common complication leading to intensive care unit (ICU) admission and high mortality among such patients. The use of non-invasive ventilation (NIV) or oxygen therapy among these patients remains controversial, according to the inconsistent results of several randomised clinical trials (RCTs). This meta-analysis aims to evaluate whether NIV or oxygen therapy is the more appropriate initial oxygenation strategy for the immunocompromised patients with acute respiratory failure. METHOD:We will search all the RCTs that compared the efficacy of NIV and oxygen therapy on immunocompromised adult patients with acute hypoxaemic respiratory failure on the major databases (Cochrane Library, MEDLINE, EMBASE, Web of Science and others), conference proceedings and grey literature. Eligible RCTs will be included in accordance with the pre-specified eligibility criteria. The risk of bias will be assessed using the Cochrane Collaboration criteria and the quality of evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation system. Data will be extracted with a standardised form and analysed using RevMan V.5.3 analyses software. Heterogeneity will be assessed using I2 statistic and the source of which will be investigated. Publication bias will be identified with the funnel plot. ETHICS AND DISSEMINATION:Ethical approval is not required since it is not carried out in humans. The systematic review will be published in peer-reviewed journals and disseminated extensively through conferences.

SUBMITTER: Li Z

PROVIDER: S-EPMC5734293 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Efficacy of non-invasive ventilation and oxygen therapy on immunocompromised patients with acute hypoxaemic respiratory failure: protocol for a systematic review and meta-analysis of randomised controlled trials.

Li Zongru Z Wang Tao T Yang Yi Y Zhang Lixi L Wang Meng M Liu Gang G He Kun K Shi Juhong J He Jianqiang J Ma Yong Y Li Yi Y Zhu Huadong H Yu Xuezhong X

BMJ open 20170630 6

<h4>Background</h4>The number of immunocompromised patients has increased in recent years. Acute respiratory failure is a common complication leading to intensive care unit (ICU) admission and high mortality among such patients. The use of non-invasive ventilation (NIV) or oxygen therapy among these patients remains controversial, according to the inconsistent results of several randomised clinical trials (RCTs). This meta-analysis aims to evaluate whether NIV or oxygen therapy is the more appro ...[more]

PMID: 28667214

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Project description:BackgroundAlthough non-invasive respiratory management strategies have been implemented to avoid intubation, patients with de novo acute hypoxaemic respiratory failure (AHRF) are high risk of treatment failure. In the previous meta-analyses, the effect of non-invasive ventilation was not evaluated according to ventilation modes in those patients. Furthermore, no meta-analyses comparing non-invasive respiratory management strategies with invasive mechanical ventilation (IMV) have been reported. We performed a network meta-analysis to compare the efficacy of non-invasive ventilation according to ventilation modes with high-flow nasal oxygen (HFNO), standard oxygen therapy (SOT), and IMV in adult patients with AHRF.MethodsThe Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and Ichushi databases were searched. Studies including adults with AHRF and randomized controlled trials (RCTs) comparing two different respiratory management strategies (continuous positive airway pressure (CPAP), pressure support ventilation (PSV), HFNO, SOT, or IMV) were reviewed.ResultsWe included 25 RCTs (3,302 participants: 27 comparisons). Using SOT as the reference, CPAP (risk ratio [RR] 0.55; 95% confidence interval [CI] 0.31-0.95; very low certainty) was associated significantly with a lower risk of mortality. Compared with SOT, PSV (RR 0.81; 95% CI 0.62-1.06; low certainty) and HFNO (RR 0.90; 95% CI 0.65-1.25; very low certainty) were not associated with a significantly lower risk of mortality. Compared with IMV, no non-invasive respiratory management was associated with a significantly lower risk of mortality, although all certainties of evidence were very low. The probability of being best in reducing short-term mortality among all possible interventions was higher for CPAP, followed by PSV and HFNO; IMV and SOT were tied for the worst (surface under the cumulative ranking curve value: 93.2, 65.0, 44.1, 23.9, and 23.9, respectively).ConclusionsWhen performing non-invasive ventilation among patients with de novo AHRF, it is important to avoid excessive tidal volume and lung injury. Although pressure support is needed for some of these patients, it should be applied with caution because this may lead to excessive tidal volume and lung injury. Trial registration protocols.io (Protocol integer ID 49375, April 23, 2021). https://doi.org/10.17504/protocols.io.buf7ntrn .

Project description:IntroductionTracheal intubation in the intensive care unit (ICU) is associated with severe life-threatening complications including severe hypoxaemia. Preoxygenation before intubation has been recommended in order to decrease such complications. Non-invasive ventilation (NIV)-assisted preoxygenation allows increased oxygen saturation during the intubation procedure, by applying a positive end-expiratory pressure (PEEP) to prevent alveolar derecruitment. However, the NIV mask has to be taken off after preoxygenation to allow the passage of the tube through the mouth. The patient with hypoxaemia does not receive oxygen during this period, at risk of major hypoxaemia. High-flow nasal cannula oxygen therapy (HFNC) has a potential for apnoeic oxygenation during the apnoea period following the preoxygenation with NIV. Whether application of HFNC combined with NIV is more effective at reducing oxygen desaturation during the intubation procedure compared with NIV alone for preoxygenation in patients with hypoxaemia in the ICU with acute respiratory failure remains to be established.Methods and analysisThe HFNC combined to NIV for decreasing oxygen desaturation during the intubation procedure in patients with hypoxaemia in the ICU (OPTINIV) trial is an investigator-initiated monocentre randomised controlled two-arm trial with assessor-blinded outcome assessment. The OPTINIV trial randomises 50 patients with hypoxaemia requiring orotracheal intubation for acute respiratory failure to receive NIV (pressure support=10, PEEP=5, fractional inspired oxygen (FiO2)=100%) combined with HFNC (flow=60 L/min, FiO2=100%, interventional group) or NIV alone (reference group) for preoxygenation. The primary outcome is lowest oxygen saturation during the intubation procedure. Secondary outcomes are intubation-related complications, quality of preoxygenation and ICU mortality.Ethics and disseminationThe study project has been approved by the appropriate ethics committee (CPP Sud-Méditerranée). Informed consent is required. If combined application of HFNC and NIV for preoxygenation of patients with hypoxaemia in the ICU proves superior to NIV preoxygenation, its use will become standard practice, thereby decreasing hypoxaemia during the intubation procedure and potential complications related to intubation.Trial registration numberNCT02530957.

Project description:Acute respiratory failure (ARF) remains the leading reason for intensive care unit (ICU) admission of immunocompromised patients. In the most severe cases, high-flow oxygen therapy may fail to ensure adequate gas exchange, and mechanical ventilation (MV) must be used. This scenario is associated with high mortality rates of 40 to 60%, depending on the cause of ARF and type of immune deficiency. The use of non-invasive ventilation (NIV) in this situation has been criticized as potentially delaying the initiation of optimal treatment. In contrast, early NIV used prophylactically in patients with ARF who do not meet the criteria for invasive MV (IMV) may obviate the need for IMV, thereby decreasing the morbidity and mortality rates. We aim to demonstrate that a management strategy including early NIV decreases 28-day mortality rates compared to oxygen therapy alone in immunocompromised patients with ARF.This is a multicenter parallel-group randomized controlled trial comparing early NIV to oxygen therapy alone in immunocompromised patients with ARF. All immunocompromised adult patients admitted to admission for ARF are eligible for randomization. Patient with ARF onset more than 72 hours earlier or ARF related to cardiogenic pulmonary edema or hypercapnia, or with a need for immediate endotracheal intubation or other organ failure are not eligible.After inclusion patient are allocated to receive early NIV (intervention arm) or oxygen therapy only (control arm).We plan to enroll 374 patients in 29 ICUs. An interim analysis is planned after the inclusion of 187 patients. The main objective is to demonstrate early NIV increases survival as compared to oxygen therapy alone. Other outcomes include the need of IMV, organ failure evolution, nosocomial infections rate, 6 months survival.This study is expected to demonstrate an improved 28-day survival in immunocompromised patients managed with early NIV.Clinicaltrials.gov NCT01915719. Registered on 26 July 2013.

Dataset Information

Efficacy of non-invasive ventilation and oxygen therapy on immunocompromised patients with acute hypoxaemic respiratory failure: protocol for a systematic review and meta-analysis of randomised controlled trials.

Publications

Efficacy of non-invasive ventilation and oxygen therapy on immunocompromised patients with acute hypoxaemic respiratory failure: protocol for a systematic review and meta-analysis of randomised controlled trials.

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