Ferran Roche-Campo

Determinants of Procedural Pain Intensity in the Intensive Care Unit. The Europain® Study

RATIONALE Intensive care unit (ICU) patients undergo several diagnostic and therapeutic procedures every day. The prevalence, intensity, and risk factors of pain related to these procedures are not well known. OBJECTIVES To assess self-reported procedural pain intensity versus baseline pain, examine pain intensity differences across procedures, and identify risk factors for procedural pain intensity. METHODS Prospective, cross-sectional, multicenter, multinational study of pain intensity associated with 12 procedures. Data were obtained from 3,851 patients who underwent 4,812 procedures in 192 ICUs in 28 countries. MEASUREMENTS AND MAIN RESULTS Pain intensity on a 0-10 numeric rating scale increased significantly from baseline pain during all procedures (P < 0.001). Chest tube removal, wound drain removal, and arterial line insertion were the three most painful procedures, with median pain scores of 5 (3-7), 4.5 (2-7), and 4 (2-6), respectively. By multivariate analysis, risk factors independently associated with greater procedural pain intensity were the specific procedure; opioid administration specifically for the procedure; preprocedural pain intensity; preprocedural pain distress; intensity of the worst pain on the same day, before the procedure; and procedure not performed by a nurse. A significant ICU effect was observed, with no visible effect of country because of its absorption by the ICU effect. Some of the risk factors became nonsignificant when each procedure was examined separately. CONCLUSIONS Knowledge of risk factors for greater procedural pain intensity identified in this study may help clinicians select interventions that are needed to minimize procedural pain. Clinical trial registered with www.clinicaltrials.gov (NCT 01070082).

A new classification for sleep analysis in critically ill patients.

BACKGROUND Patients in intensive care units (ICUs) experience severe sleep alterations and conventional sleep scoring rules are difficult to use in these patients. In a previous study, we showed that abnormal sleep EEG and wake EEG patterns could predict the outcome of noninvasive ventilation in a group of patients treated for acute respiratory failure. Our aims were to assess the prevalence of these abnormal sleep/wake EEG patterns in a larger group and search for objective parameters to help their identification. METHODS We reviewed sleep studies previously performed with full polysomnography during 17-h in conscious nonsedated ICU patients receiving invasive ventilation during weaning or noninvasive ventilation for acute respiratory failure. RESULTS We included 57 patients. Sleep scoring using conventional rules was not feasible in 16 (28%) patients due to the absence of stage-2 markers. Wake EEG in these 16 patients, although recognizable, showed abnormal features, including decreased reactivity to eye opening and slower peak EEG frequency compared to patients with normal sleep-wake EEGs. CONCLUSION In almost one third of awake mechanically ventilated ICU patients, sleep cannot be classified with standard criteria. Two new states, atypical sleep and pathologic wakefulness, need to be added. We suggest rules for scoring these states. The origin and links with outcomes of these abnormal EEG patterns deserve investigation.

Ventilator-Associated Pneumonia During Weaning From Mechanical Ventilation: Role of Fluid Management

BACKGROUND Pulmonary edema may alter alveolar bacterial clearance and infectivity. Manipulation of fluid balance aimed at reducing fluid overload may, therefore, influence ventilator-associated pneumonia (VAP) occurrence in intubated patients. The objective of the present study was to assess the impact of a depletive fluid-management strategy on ventilator-associated complication (VAC) and VAP occurrence during weaning from mechanical ventilation. METHODS We used data from the B-type Natriuretic Peptide for the Fluid Management of Weaning (BMW) randomized controlled trial performed in nine ICUs across Europe and America. We compared the cumulative incidence of VAC and VAP between the biomarker-driven, depletive fluid-management group and the usual-care group during the 14 days following randomization, using specific competing-risk methods (the Fine and Gray model). RESULTS Among the 304 patients analyzed, 41 experienced VAP, including 27 (17.8%) in the usual-care group vs 14 (9.2%) in the interventional group (P = .03). From the Fine and Gray model, the probabilities of VAC and VAP occurrence were both significantly reduced with the interventional strategy while adjusting for weaning outcome as a competing event (subhazard ratios [25th-75th percentiles], 0.44 [0.22-0.87], P = .02 and 0.50 [0.25-0.96], P = .03, respectively). CONCLUSIONS Using proper competing risk analyses, we found that a depletive fluid-management strategy, when initiating the weaning process, has the potential for lowering VAP risk in patients who are mechanically ventilated. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT00473148; URL: www.clinicaltrials.gov.

Original ResearchCritical CareVentilator-Associated Pneumonia During Weaning From Mechanical Ventilation: Role of Fluid Management

BACKGROUND Pulmonary edema may alter alveolar bacterial clearance and infectivity. Manipulation of fluid balance aimed at reducing fluid overload may, therefore, influence ventilator-associated pneumonia (VAP) occurrence in intubated patients. The objective of the present study was to assess the impact of a depletive fluid-management strategy on ventilator-associated complication (VAC) and VAP occurrence during weaning from mechanical ventilation. METHODS We used data from the B-type Natriuretic Peptide for the Fluid Management of Weaning (BMW) randomized controlled trial performed in nine ICUs across Europe and America. We compared the cumulative incidence of VAC and VAP between the biomarker-driven, depletive fluid-management group and the usual-care group during the 14 days following randomization, using specific competing-risk methods (the Fine and Gray model). RESULTS Among the 304 patients analyzed, 41 experienced VAP, including 27 (17.8%) in the usual-care group vs 14 (9.2%) in the interventional group (P = .03). From the Fine and Gray model, the probabilities of VAC and VAP occurrence were both significantly reduced with the interventional strategy while adjusting for weaning outcome as a competing event (subhazard ratios [25th-75th percentiles], 0.44 [0.22-0.87], P = .02 and 0.50 [0.25-0.96], P = .03, respectively). CONCLUSIONS Using proper competing risk analyses, we found that a depletive fluid-management strategy, when initiating the weaning process, has the potential for lowering VAP risk in patients who are mechanically ventilated. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT00473148; URL: www.clinicaltrials.gov.

Comparison of Sleep Quality With Mechanical Versus Spontaneous Ventilation During Weaning of Critically Ill Tracheostomized Patients

Background:In mechanically ventilated patients under mechanical ventilation in the ICU, ventilatory mode or settings may influence sleep quality. The aim of this study was to evaluate the direct impact of mechanical ventilation per se on sleep quantity and quality in patients who were able to tolerate separation from mechanical ventilation over prolonged periods. Design and Setting:Randomized crossover clinical trial in a medical ICU. Patients:Sixteen conscious patients, free of sedation and tracheostomized because of prolonged weaning from mechanical ventilation, were included in the study when able to tolerate at least 5 hours of spontaneous ventilation. Interventions:Patients were randomized to receive either spontaneous ventilation or mechanical ventilation at low levels of pressure support for two crossover periods of 5-hour duration each, from 22:00 to 08:00. Polysomnography was performed throughout the study. Measurements and Results:Total sleep time was higher during mechanical ventilation than during spontaneous ventilation (183 min vs 132 min, p = 0.04). No significant differences between mechanical ventilation and spontaneous ventilation were observed in slow wave sleep time (45 min vs 28 min), rapid eye movement sleep time (11 min vs 3 min), or the fragmentation index (25 vs 23 arousals and awakenings per hr). In four patients, however, our analysis of patient–ventilator interaction suggested that the ventilatory settings were suboptimal and could have been improved to potentially improve sleep. Conclusions:In difficult-to-wean tracheostomized patients, sleep quality was similar with or without the ventilator. Sleep quantity was higher during mechanical ventilation. Reconnection to the ventilator during the night period may favor sleep efficiency in tracheostomized patients in prolonged weaning.

Results of noninvasive ventilation in very old patients

BackgroundNoninvasive ventilation (NIV) is frequently used for the management of acute respiratory failure (ARF) in very old patients (≥ 80 years), often in the context of a do-not-intubate order (DNI). We aimed to determine its efficacy and long-term outcome.MethodsProspective cohort of all patients admitted to the medical ICU of a tertiary hospital during a 2-year period and managed using NIV. Characteristics of patients, context of NIV, and treatment intensity were compared for very old and younger patients. Six-month survival and functional status were assessed in very old patients.ResultsDuring the study period, 1,019 patients needed ventilatory support and 376 (37%) received NIV. Among them, 163 (16%) very old patients received ventilatory support with 60% of them managed using NIV compared with 32% of younger patients (p < 0.0001). Very old patients received NIV more frequently with DNI than in younger patients (40% vs. 8%). Such cases were associated with high mortality for both very old and younger patients. Hospital mortality was higher in very old than in younger patients but did not differ when NIV was used for cardiogenic pulmonary edema or acute-on-chronic respiratory failure (20% vs. 15%) and in postextubation (15% vs. 17%) out of a context of DNI. Six-month mortality was 51% in very old patients, 67% for DNI patients, and 77% in case of NIV failure and endotracheal intubation. Of the 30 hospital survivors, 22 lived at home and 13 remained independent for activities of daily living.ConclusionsVery old patients managed using NIV have an overall satisfactory 6-month survival and functional status, except for endotracheal intubation after NIV failure.

Sleep in hypercapnic critical care patients under noninvasive ventilation: conventional versus dedicated ventilators.

Objective:To compare sleep quality between two types of ventilators commonly used for noninvasive ventilation: conventional ICU ventilators and dedicated noninvasive ventilators; and to evaluate sleep during and between noninvasive ventilation sessions in critically ill patients. Design:Physiological sleep study with a randomized assessment of the ventilator type. Setting:Medical ICU in a university hospital. Patients:Twenty-four patients admitted for acute hypercapnic respiratory failure requiring noninvasive ventilation. Interventions:Patients were randomly assigned to receive noninvasive ventilation with either an ICU ventilators (n = 12) or a dedicated noninvasive ventilators (n = 12), and their sleep and respiratory parameters were recorded by polysomnography from 4 PM to 9 AM on the second, third, or fourth day after noninvasive ventilation initiation. Measurements and Main Results:Sleep architecture was similar between ventilator groups, including sleep fragmentation (number of arousals and awakenings/hr), but the dedicated noninvasive ventilators group showed a higher patient–ventilator asynchrony-related fragmentation (28% [17–44] vs. 14% [7.0–22]; p = 0.02), whereas the ICU ventilators group exhibited a higher noise-related fragmentation. Ineffective efforts were more frequent in the dedicated noninvasive ventilators group than in the ICU ventilators group (34 ineffective efforts/hr of sleep [15–125] vs. two [0–13]; p < 0.01), possibly as a result of a higher tidal volume (7.2 mL/kg [6.7–8.8] vs. 5.8 [5.1–6.8]; p = 0.04). More sleep time occurred and sleep quality was better during noninvasive ventilation sessions than during spontaneous breathing periods (p < 0.05) as a result of greater slow wave and rapid eye movement sleep and lower fragmentation. Conclusions:There were no observed differences in sleep quality corresponding to the type of ventilator used despite slight differences in patient–ventilator asynchrony. Noninvasive ventilation sessions did not prevent patients from sleeping; on the contrary, they seem to aid sleep when compared with unassisted breathing.

Delirium and Circadian Rhythm of Melatonin During Weaning From Mechanical Ventilation: An Ancillary Study of a Weaning Trial

BACKGROUND Delirium is frequent in patients in the ICU, but its association with the outcome of weaning from mechanical ventilation has not been assessed. Circadian rhythm alteration may favor delirium. In the current study, we assessed the impact of delirium during weaning and associated alterations in the circadian rhythm of melatonin excretion. METHODS This was a substudy of 70 participants of the B-type Natriuretic Peptide for the Fluid Management of Weaning trial, comparing two fluid management strategies during weaning. Patients with or without delirium (as assessed using the Confusion Assessment Method for the ICU) were compared in terms of baseline characteristics and outcomes and the circadian rhythm of melatonin excretion using the 24-h excretion of its urinary metabolite 6-sulfatoxymelatonin (aMT6s). RESULTS Among the 70 patients included, 43 (61.4%) experienced delirium at the initiation of weaning. Delirium at the initiation of weaning was associated with more alcohol consumption, a greater severity of illness, and medication use before weaning (including neuromuscular blockade, antibiotics, sedatives, and narcotics). Delirium at the initiation of weaning was associated with more respiratory and neurologic complications and a reduced probability of successful extubation (Cox multivariate model hazard ratio of successful extubation = 0.54; 95% CI, 0.30-0.95; P = .03). Delirium was also associated with a significant reduction in peak, mean, amplitude, and total values of aMT6s urinary excretion during the first 24 h of weaning (general linear model F statistic = 5.81, P = .019). CONCLUSIONS Delirium is frequent at the initiation of ventilator weaning. It is associated with a prolongation of weaning and an alteration in the circadian rhythm of melatonin excretion. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT00473148; URL: www.clinicaltrials.gov.

Prone positioning in acute respiratory distress syndrome (ARDS): When and how?

Acute respiratory distress syndrome (ARDS) is a severe form of respiratory failure. It remains one of the most devastating conditions in the intensive care unit. Mechanical ventilation with positive end-expiratory pressure is a cornerstone therapy for ARDS patients. One adjuvant alternative is to place the patient in a prone position. Since it was first described in 1976, prone positioning has been safely employed to improve oxygenation in many patients with ARDS. Prone positioning may also minimize secondary lung injury induced by mechanical ventilation, although this benefit has not been investigated as extensively, despite its potential. In spite of a strong physiological justification, prone positioning is still not widely accepted as an adjunct therapy in ARDS patients and it is only used regularly in only 10% of ICUs. This may be explained in part by the reluctance to change position, risks and unclear effects on relevant outcomes. In this paper, we review all aspects of prone positioning, from the pathophysiology to the clinical studies of patient outcome, and we also discuss the latest controversies surrounding this treatment.

A randomized controlled trial of fentanyl in the pre-emptive treatment of pain associated with turning in patients under mechanical ventilation: research protocol.

AIM To compare the effectiveness and safety of fentanyl with placebo as pre-emptive treatment for pain associated with turning in patients in intensive care units. BACKGROUND Turning is frequently a painful procedure in this setting. Pre-emptive administration of supplementary analgesia may help decrease this pain. However, medical literature on pre-emptive analgesia in these patients is scarce. DESIGN A randomized, double-blind, controlled clinical trial. METHODS This study will assess the benefits and risks of pre-emptive analgesia with fentanyl compared with placebo on turning-associated pain. Eighty patients will be recruited from among those older than 18 years and needing mechanical ventilation for at least 24 hours. Pain intensity will be assessed using the Behavioral Pain Scale. Primary outcome will be pain intensity between the baseline and 30 minutes after turning, measured by the area under the curve of the pain scale scores. Secondary outcomes will be the usefulness of physiological parameters and the Bispectral Index to measure pain and the safety of pre-emptive fentanyl in turning. The study protocol was approved in February 2011. DISCUSSION If pre-emptive fentanyl is more effective than placebo and reasonably safe, the results of the current study may change nursing attitude in managing turning in critically ill patients. As a consequence, pain may be decreased during this nursing procedure.