Acta anaesthesiologica Scandinavica
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Acta Anaesthesiol Scand · Jul 2023
Randomized Controlled TrialComparing Restrictive vs. Liberal Oxygen Strategies for Trauma Patients: The TRAUMOX2 Trial - Statistical Analysis Plan.
The international advanced trauma life support guidelines recommend that all severely injured trauma patients receive supplemental oxygen based on very limited evidence. The TRAUMOX2 trial randomises adult trauma patients to a restrictive or liberal oxygen strategy for 8 h. The primary composite outcome consists of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). This manuscript presents the statistical analysis plan for TRAUMOX2. ⋯ This statistical analysis plan of the TRAUMOX2 trial will minimise bias and add transparency to the statistics applied in the analysis of the trial. The results will add evidence on restrictive and liberal supplemental oxygen strategies for trauma patients.
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Acta Anaesthesiol Scand · Jul 2023
Randomized Controlled TrialIncidence of bradycardia during noradrenaline or phenylephrine bolus treatment of postspinal hypotension in cesarean delivery: A randomized double-blinded controlled trial.
The treatment of choice for spinal anesthesia-induced hypotension during cesarean section is phenylephrine. As this vasopressor can cause reflex bradycardia, noradrenaline is a suggested alternative. This randomized double-blinded controlled trial included 76 parturients undergoing elective cesarean delivery under spinal anesthesia. ⋯ When administered in intermittent bolus doses for the treatment of postspinal hypotension in elective cesarean delivery, noradrenaline, and phenylephrine have a similar incidence of bradycardia. When treating hypotension related to spinal anesthesia in obstetric cases, strong vasopressors are commonly administered, thought these can also have side effects. This trial assessed bradycardia after bolus administration of noradrenaline or phenylephrine, and found no difference in risk for clinically meaningful bradycardia.
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Acta Anaesthesiol Scand · Jul 2023
Randomized Controlled TrialAtrial natriuretic peptide in the prevention of acute renal dysfunction after heart transplantation - a randomized placebo-controlled double-blind trial.
Acute kidney injury (AKI) and renal dysfunction after heart transplantation are common and serious complications. Atrial natriuretic peptide (ANP) has been shown to increase glomerular filtration rate (GFR) and exert renoprotective effects when used for the prevention/treatment of AKI in cardiac surgery. We tested the hypothesis that intraoperative and postoperative administration of ANP could prevent a postoperative decrease in renal function early after heart transplantation. ⋯ The study failed to detect that ANP infusion attenuates renal dysfunction or decreases the incidence of AKI after heart transplantation.
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Acta Anaesthesiol Scand · Apr 2023
Randomized Controlled TrialWearable device for prevention of postoperative and post-discharge hypoxemia: a randomized pilot trial.
The Oxalert Enhanced Pulse Oximeter (EPO) is a wearable device that detects and alerts patients to hypoxemia. In a preplanned pilot trial, we estimated the effect of continuous saturation monitoring with patient alerts on in-hospital and post-discharge saturation; we further assessed the feasibility of the intervention. ⋯ The Oxalert system was well tolerated in both groups and enrollment was strong. Patients randomized to active Oxalert systems experienced half as many postoperative desaturation events while hospitalized, although the difference was not statistically significant in this small pilot trial. In contrast, the Oxalert system did not reduce post-discharge desaturation. Detecting postoperative deterioation in surgical patients after they arrive on regular hospital wards, and even after they have been discharged home, can potentially facilitate necessary "rescue" interventions. Wearable devices assessing vital signs, including oxygenation, are a practical requirement. In this pilot study, a wearable pulse oximeter, with and without hypoxemia alarms, was tested for feasibility and acceptability for signal collection in postoperative cases, including at home. Results indicate that a full-scale trial is warranted to test for possible clinical benefit with this type of "wearable" where late postoperative hypoxia could be a concern. The trial was registered at ClincialTrial.gov (NCT04453722).
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Acta Anaesthesiol Scand · Apr 2023
Randomized Controlled TrialInfrared flashing light through the cricothyroid membrane as guidance to awake intubation with a flexible bronchoscope: A randomised cross-over study.
In case of distorted airway anatomy, awake intubation with a flexible bronchoscope can be extremely difficult or even impossible. To facilitate this demanding procedure, an infrared flashing light source can be placed on the patient's neck superficial to the cricothyroid membrane. The light travels through the skin and tissue to the trachea, from where it can be registered by the advancing bronchoscope in the pharynx and seen as flashing white light on the monitor. We hypothesised that the application of this technique would allow more proximal and easier identification of the correct pathway to the trachea in patients with severe airway pathology. ⋯ NCT03930550.