Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial.

BACKGROUND: Mechanical ventilation (MV) is a life-saving technology that restores or assists breathing. Like any treatment, MV has side effects. In some patients it can cause diaphragmatic atrophy, injury, and dysfunction (ventilator-induced diaphragmatic dysfunction, VIDD). Accumulating evidence suggests that VIDD makes weaning from MV difficult, which involves increased morbidity and mortality. METHODS AND ANALYSIS: This paper describes the protocol of a randomized, controlled, open-label, multicenter trial that is designed to investigate the safety and effectiveness of a novel therapy, temporary transvenous diaphragm pacing (TTVDP), to improve weaning from MV in up to 88 mechanically ventilated adult patients who have failed at least two spontaneous breathing trials over at least 7 days. Patients will be randomized (1:1) to TTVDP (treatment) or standard of care (control) groups. The primary efficacy endpoint is time to successful extubation with no reintubation within 48 h. Secondary endpoints include maximal inspiratory pressure and ultrasound-measured changes in diaphragm thickness and diaphragm thickening fraction over time. In addition, observational data will be collected and analyzed, including 30-day mortality and time to discharge from the intensive care unit and from the hospital. The hypothesis to be tested postulates that more TTVDP patients than control patients will be successfully weaned from MV within the 30 days following randomization. DISCUSSION: This study is the first large-scale clinical trial of a novel technology (TTVDP) aimed at accelerating difficult weaning from MV. The technology tested provides the first therapy directed specifically at VIDD, an important cause of delayed weaning from MV. Its results will help delineate the place of this therapeutic approach in clinical practice and help design future studies aimed at defining the indications and benefits of TTVDP. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03096639 . Registered on 30 March 2017.

Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study).

INTRODUCTION: Respiratory muscle dysfunction has been associated with failure to wean from mechanical ventilation. It has therefore been hypothesised that these patients might benefit from inspiratory muscle training (IMT). Evidence, however, is thus far limited to data from small, single-centre studies with heterogeneity in inclusion criteria, training modalities and outcomes. The aim of this study is to evaluate the effects of a novel IMT method on weaning outcomes in selected patients with weaning difficulties. METHODS: This study is designed as a double-blind, parallel-group, randomised controlled superiority trial with 1:1 allocation ratio. Patients with weaning difficulties will be randomly allocated into either an IMT group (intervention) or a sham-IMT group (control). Ninetypatients (45 in each group) will be needed to detect a 28% difference in the proportion of weaning success between groups (estimated difference in primary outcome based on previous studies) with a risk for type I error (α) of 5% and statistical power (1-ß) of 80%. Patients will perform four sets of 6-10 breaths daily against an external load using a tapered flow resistive loading device (POWERbreathe KH2, HaB International, UK). Training intensity in the intervention group will be adjusted to the highest tolerable load. The control group will train against a low resistance that will not be modified during the training period. Training will becontinued until patients are successfully weaned or for a maximum duration of 28 days. Pulmonary and respiratory muscle function, weaning duration, duration of mechanical ventilation, ventilator-free days and length of stay in the intensive care unit will be evaluated as secondary outcomes. Χ2 tests and analysis of covariance with adjustments for baseline values of respective outcomesas covariates will be used to compare results after the intervention period between groups. ETHICS AND DISSEMINATION: Ethics approval was obtained from the local ethical committee (Ethische Commissie Onderzoek UZ/KU Leuven protocol ID: S60516). Results from this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peerreviewed journals. TRIAL STATUS: Enrolment into the study have started in August 2017. Data collection and data analysis are expected to be completed in September 2021. TRIAL REGISTRATION NUMBER: NCT03240263.

Diaphragm electromyography guidance for a lung transplant recipient with difficult weaning from mechanical ventilation: A case report.

RATIONALE: Many factors contribute to a complicated postoperative course following difficult weaning off a ventilator after lung transplantation. PATIENT CONCERNS: A female patient underwent a successful surgery but received a size-mismatched lung graft. The graft had been pruned before transplantation. She experienced delayed ventilator weaning 3 days after lung transplantation. DIAGNOSES: A postoperative X-ray revealed a normal mediastinal structure and diaphragm position. Diaphragmatic function was assessed by diaphragm electromyography (EMGdi) via esophageal and surface electrodes. EMGdi showed decreased left compound motor action potentials (CMAPs), prolonged left phrenic nerve conduction time (PNCT), failure to induce right CMAPs and PNCT under bilateral magnetic stimulation, and right phrenic nerve injury. INTERVENTIONS: She was treated with neural nutritional support and prescribed rehabilitation measures such as strengthening limb activities on the bed. OUTCOMES: The patient finally achieved satisfactory outcomes after an early diagnosis and medical interventions. LESSONS: Lung size mismatch before transplantation and phrenic nerve injury during surgery should be avoided wherever possible.

The Care-Integrated Concentration Meditation Program for Patients With Weaning Difficulty: A Pilot Study.

Because of the multifaceted process of weaning patients with prolonged mechanical ventilation, enhancing weaning success remains a challenge. The Care-Integrated Concentration Meditation Program was developed on the basis of Buddhist philosophy and implemented to determine its procedural feasibility. A qualitative case study with 3 participants was conducted, and the process and initial outcomes were evaluated.

[Weaning--definition and clinical context from the anesthetic point of view]. / Respiratorentwöhnung--Definition und klinischer Kontext aus Sicht der Anästhesie.

Independent from the mode of mechanical ventilation, particularly a quick termination of mechanical ventilation is essential for the weaning progress. Respirator-associated complications need to be early detected and treated. Thus it is important to know correspondent pathomechanisms as they have a crucial influence on the weaning process.To facilitate a holistic treatment approach for patients in prolonged weaning, a tight junction of intensive care within specialized units seems mandatory.

Adequacy of oral intake in critically ill patients 1 week after extubation.

Hospital malnutrition is associated with increased morbidity and mortality, particularly among patients admitted to intensive care units (ICUs). The purpose of this observational study (August to November 2007) was to examine the adequacy of oral intake and to identify predictors of oral intake after ICU patients were removed from invasive mechanical ventilation. Patients aged > or = 18 years who required mechanical ventilation for at least 24 hours, advanced to an oral diet postextubation, and did not require supplemental enteral or parenteral nutrition were included. The first 7 days of oral intake after extubation were assessed via modified multiple-pass 24-hour recall and the numbers of days on therapeutic diets and reasons for decreased intake were collected. Oral intake <75% of daily requirements was considered inadequate. Descriptive statistics, chi2, Student t tests, and logistic regression analyses were conducted. Of the 64 patients who met eligibility criteria, 50 were included. Of these 50 patients, 54% were women and intubated for 5.2 days, with a mean age of 59.1 years, body mass index of 28.7, and Acute Physiology and Chronic Health Evaluation II score of 21.9. Subjective Global Assessment determined 44% were malnourished upon admission to the ICU. The average daily energy and protein intake failed to exceed 50% of daily requirements on all 7 days for the entire population. The majority of patients who consumed <75% of daily requirements were prescribed a therapeutic diet and/or identified "no appetite" and nausea/vomiting as the barriers to eating. Although more research is needed, these data call into question the use of restrictive oral diets and suggest that alternative medical nutrition therapies are needed to optimize nutrient intake in this unique patient population.

Levine's framework in long-term ventilated patients during the weaning course.

Within the context of Levine's conceptual framework, this study evaluated fatigue and protein calorie malnutrition affecting adult, long-term ventilated patients during the weaning process. Levine's principles of energy and structural integrity provided the basis for an evaluation of the fatigue and prealbumin levels for 11 patients. During the weaning process (1 to 4 weeks), fatigue data were collected at multiple points while prealbumin levels were collected weekly. Statistically significant findings revealed that long-term ventilated patients had distinctive fatigue trends in addition to trends associated with low prealbumin levels, which can affect the patient's weaning ability.