Figure 2

Nursing home tracheostomy care Heredia

Heredia / May 16, 2017

The trial is completed in at the least seven ICUs, one in a university-affiliated hospital (the educational infirmary, Amsterdam) and six in training hospitals (Rijnstate Hospital, Arnhem; Onze Lieve Vrouwe Gasthuis, Amsterdam; Amphia Hospital, Breda, Oosterhout and Ettenleur; Antonius Hospital, Nieuwegein; Medical Center Haaglanden, The Hague and Leidschendam; and Isala Hospital, Zwolle) within the Netherlands.


Invasively ventilated adult nonpregnant customers, elderly ≥18 many years, with an anticipated length of time of ventilation of greater than a day, are eligible for participation. Customers tend to be excluded should they got unpleasant air flow an additional ICU right preceding today's ICU entry; air flow during transportation into hospital, or ventilation were only available in the er or in the operating theater is permitted however. Where the health background necessitates the continuation of bronchodilators (as an example, for chronic obstructive pulmonary illness or symptoms of asthma) or in situations of a known sensitivity on trial medication, the in-patient should be omitted from involvement. Customers with neuromuscular diseases or complete spinal-cord lesions, and consequently with an expected requirement for long-term ventilation, are also omitted. Finally, earlier randomization inside NEBULAE trial excludes clients from participation also.

Patient enrollment, randomization and blinding

Consecutive patients tend to be screened for eligibility by neighborhood investigators and managing doctors. Customers meeting all addition criteria and no exclusion criteria are candidates for addition inside study and will also be randomly assigned in a 1 to 1 proportion, after well-informed consent is distributed by the individual or their particular legal representative, to either a method of preventive nebulization of acetylcysteine and salbutamol four times every day (the ‘preventive nebulization’ arm) or nebulization of acetylcysteine or salbutamol on indication (the ‘nebulization on sign’ supply). Randomization will likely to be carried out by the regional detectives and treating physicians as soon as possible, but always within 24 hours after start of unpleasant ventilation in ICU. In order to avoid prediction of future patients’ allocation, randomization sequence is produced making use of a permuted block design with arbitrary block dimensions stratified by study center. Maintenance of allocation concealment is going to be warranted using a central, devoted, password-protected, SSL-encrypted web-based, automatic randomization system, offered a day a day (ALEA® computer software, TenALEA consortium, Amsterdam, holland), developed by the medical analysis Unit within the educational infirmary, Amsterdam, The Netherlands, which will be perhaps not mixed up in conduct of the research. Because of the nature regarding the input, blinding of this clients and caregivers is not feasible. Results evaluation is going to be done according to the study protocol by independent ICU doctors perhaps not mixed up in test. Investigators performing analysis tend to be blinded for intervention.

The assigned method is proceeded until tracheal extubation. If someone needs reintubation and extra invasive ventilation within a period of 28 times, the technique to that your client is randomized will likely be resumed.


Whenever randomized toward preventive nebulization supply, the patient will get nebulization every 6 hours with solutions containing 300 mg acetylcysteine plus 2.5 mg salbutamol. Flasks of acetylcysteine and salbutamol are supplied because of the pharmacy regarding the participating center. Since no placebo will undoubtedly be made use of, labeling associated with medications is not essential. Solutions tend to be nebulized using jet nebulizers or vibrating mesh nebulizers, according to neighborhood access in participating centers. Nebulizers are set relating to manufacturer’s tips. External nebulizers are run on pressured atmosphere or oxygen at a continuous movement of 3 to 5 L/min. The nebulizer may be attached to the tubing system, constantly following the heated humidifier or the heat and moisture exchange (HME) filter (this is certainly, beside the patient). A nebulization program typically persists 20 to 30 minutes. The type of nebulizer utilized should be taped in case record type (CRF).

Whenever randomized toward nebulization on indicator supply, nebulization of acetylcysteine or salbutamol is fixed. The doctor staff can choose purchase nebulization of solutions containing 300 mg acetylcysteine 2.5 mg salbutamol in the event someone has persistent dense and tenacious secretions or in situations of bronchospasm (suspected if you have a clinical wheezing, and signs and symptoms of obstruction of the lower airways on ventilator waves or the end-tidal CO2 curve), respectively. Day-to-day reassessment for the indications mentioned previously will reassure that nebulization is stopped whenever no more needed. The decision to begin and prevent nebulization is recorded within the CRF.