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Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial.

ABSTRACT:

SUBMITTER: Carvalho AC

PROVIDER: S-EPMC8039799 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial.

Carvalho Ana Cristina AC Moreira Jorge J Cubelo Pedro P Cantista Pedro P Branco Catarina Aguiar CA Guimarães Bruno B

Trials 20210412 1

<h4>Objectives</h4>The primary objective of the presented study is to analyze the respiratory and functional effects of a rehabilitation program in patients affected by hospitalization in Intensive Care Unit (ICU) due to COVID-19, in comparison with the group treated with standard of care, at discharge endpoint. The secondary objectives of the presented study are to evaluate different outcomes of the rehabilitation program in comparison to standard of care regarding: functional performance at 4- ...[more]

PMID: 33845878

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Project description:IntroductionBoth physical and mental disorders may be exacerbated in patients with COVID-19 due to the experience of receiving intensive care; undergoing prolonged mechanical ventilation, sedation, proning and paralysis. Pulmonary rehabilitation is aimed to improve dyspnoea, relieve anxiety and depression, reduce the incidence of related complications, as well as prevent and improve dysfunction. However, the impact of respiratory rehabilitation on discharged patients with COVID-19 is currently unclear, especially on patients who have been mechanically ventilated over 24 hours. Therefore, we aim to investigate the efficacy of respiratory rehabilitation programmes, initiated after discharge from the intensive care unit, on the physical and mental health and health-related quality of life in critical patients with COVID-19.Methods and analysisWe have registered the protocol on PROSPERO and in the process of drafting it, we strictly followed the checklist of Preferred Reporting Items for Systematic Review and Meta-Analysis Potocols. We will search the PubMed, EMBASE, Web of Science, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, WanFang, VIP information databases and Chinese Biomedical Literature Database. Additionally, ongoing trials in the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov and ISRCTN registry will be searched as well. Studies in English or Chinese and from any country will be accepted regardless of study design. Two review authors will independently extract data and assess the quality of included studies. Continuous data are described as standard mean differences (SMDs) with 95% CIs. Dichotomous data from randomised controlled trials are described as risk ratio(RR) with 95% CIs; otherwise, it is described as odds ratio(OR) with 95% CIs. I2 and the Cochrane's Q statistic will be used to conduct heterogeneity assessment. The quality of evidence of main outcomes will be evaluated according to the Grading of Recommendations, Assessment, Development and Evaluation(GRADE) criteria. When included studies are sufficient, we will conduct subgroup analysis and sensitivity analysis; the publication bias will be statistically analysed using a funnel plot analysis and Egger's test.Ethics and disseminationOur review, planning to include published studies, does not need the request to the ethical committee. The final results of this review will be published in a peer-reviewed journal after completion.Patient and public involvementNo patient involved.Prospero registration numberCRD42020186791.

Project description:IntroductionSedation in mechanically ventilated adults in the intensive care unit (ICU) is commonly achieved with intravenous infusions of propofol, dexmedetomidine or benzodiazepines. Significant limitations associated with each can impact their usage. Inhaled isoflurane has potential benefit for ICU sedation due to its safety record, sedation profile, lack of metabolism and accumulation, and fast wake-up time. Administration in the ICU has historically been restricted by the lack of a safe and effective delivery system for the ICU. The Sedaconda Anaesthetic Conserving Device-S (Sedaconda ACD-S) has enabled the delivery of inhaled volatile anaesthetics for sedation with standard ICU ventilators, but it has not yet been rigorously evaluated in the USA. We aim to evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S compared with intravenous propofol for sedation of mechanically ventilated ICU adults in USA hospitals.Methods and analysisINhaled Sedation versus Propofol in REspiratory failure in the ICU (INSPiRE-ICU1) is a phase 3, multicentre, randomised, controlled, open-label, assessor-blinded trial that aims to enrol 235 critically ill adults in 14 hospitals across the USA. Eligible patients are randomised in a 1.5:1 ratio for a treatment duration of up to 48 (±6) hours or extubation, whichever occurs first, with primary follow-up period of 30 days and additional follow-up to 6 months. Primary outcome is percentage of time at target sedation range. Key secondary outcomes include use of opioids during treatment, spontaneous breathing efforts during treatment, wake-up time at end of treatment and cognitive recovery after treatment.Ethics and disseminationTrial protocol has been approved by US Food and Drug Administration (FDA) and central (Advarra SSU00208265) or local institutional review boards ((IRB), Cleveland Clinic IRB FWA 00005367, Tufts HS IRB 20221969, Houston Methodist IRB PRO00035247, Mayo Clinic IRB Mod22-001084-08, University of Chicago IRB21-1917-AM011 and Intermountain IRB 033175). Results will be presented at scientific conferences, submitted for publication, and provided to the FDA.Trial registration numberNCT05312385.

Project description:ObjectivesThis study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS) associated with COVID-19.We define ARDS according to the "Berlin" definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings.Trial designThis is a prospective, randomized (1:1 ratio), parallel group feasibility study in adult patients with proven COVID-19 associated ARDS.ParticipantsAll adult patients admitted to the ICU of Hamad Medical Corporation facilities in Qatar because of COVID-19 infection who develop moderate to severe ARDS are eligible. The inclusion criteria are above 18 years of age, proven COVID-19 infection, respiratory failure necessitating intubation and mechanical ventilation, ARDS with a P/F ratio of at least 200mmHg or less and a minimum PEEP 5cmH2O, BMI less 30 kg/ m2. The following exclusion criteria: no written consent, chronic respiratory disease, acute or chronic cardiovascular disease, pregnancy or need for special therapy (prone position and/or Extracorporeal membrane oxygenation).Intervention and comparatorAfter randomisation, the group A patients will be ventilated with the test-device for 48 hours. The settings will be started with the pre-existing-PEEP. The upper pressure will be determined to achieve a tidal volume of 6 ml/kg lean body mass, while the respiratory rate will be set to maintain an arterial pH above 7.2. In group B, the ventilator settings will be adjusted by the attending ICU team in accordance with lung-protective ventilation strategy. All other treatment will be unchanged and according to our local policies/guidelines.Main outcomesThe primary end point is PaO2. As this is a dynamic parameter, we will record it every 6-8 hours and analyse it sequentially.RandomisationThe study team screens the ventilated patients who fulfil the inclusion criteria and randomise using a 1:1 allocation ratio after consenting using a closed envelope method. The latter were prepared and sealed in advance by an independent person.Blinding (masking)Due to the technical nature of the study (use of a specific ventilator) blinding is only possible for the data-analysts and the patients.Numbers to be randomised (sample size)The sample size calculation based on the assumption of an effect size (change in PaO2) of 1.5 SDS in the primary endpoint (PaO2), an intended power of 80%, an alpha error of 5% and an equal sample ratio results in n=7 patients needed to treat. However, to compensate for dropouts we will include 10 patients in each group, which means in total 20 patients.Trial statusThe local registration number is MRC-05-018 with the protocol version number 3. The date of approval is 14th April 2020. Recruitment began 28th May 2020 and is expected to end in September 2020.Trial registrationThe protocol was registered before starting subject recruitment under the title: "Flow controlled ventilation in ARDS associated with COVID-19" in ClinicalTrials.org with the registration number: NCT04399317 . Registered on 22 May 2020.Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Dataset Information

Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial.

Publications

Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial.

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