ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID

ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID

ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID

ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

BackgroundCentral to the tenet of informed consent is the quality of disclosure of information by the investigator and the understanding thereof by the research subject or his or her surrogate. This study was designed to measure parents’ understanding of the elements of informed consent for clinical studies in which their children had been approached to participate.MethodsThe study sample consisted of 505 parents who had been approached for permission to allow their child to participate in a clinical anesthesia or surgery study. Regardless of whether the parent consented (consenters, n = 411) or declined (nonconsenters, n = 94) to their child's participation in a study, they were interviewed to determine their understanding of 11 elements of consent. Two independent assessors who were familiar with the study protocols scored the parents’ levels of understanding.ResultsParents perceived their overall understanding of the elements of consent as high (8.7 ± 1.6; 0–10 scale); however, this represented a significant overestimation compared with the assessors’ measures of parental understanding (7.3 ± 1.8;P< 0.0001). Furthermore, consenters had greater understanding than nonconsenters (7.6 ± 1.6vs.6.1 ± 1.9;P< 0.001). Several predictors of understanding were identified, including whether the parent consented, education level, clarity of disclosure, child in previous study, age of parent, parent listened to disclosure, and degree to which parent read the consent document. The day on which consent was sought had no impact on the level of understanding.ConclusionsParents approached for permission to allow their child to participate in a research study had less than optimal understanding of the elements of consent. As such, investigators must make every effort to enhance understanding and ensure that parents have sufficient information to make informed decisions regarding their child's participation in research studies.

ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

BackgroundParticipation of children in clinical research requires not only parental permission but also the assent of the child. Although there is no fixed age at which assent should be sought, investigators should obtain assent from children considered able to provide it. This study was designed to determine children's understanding of the elements of disclosure for studies in which they had assented to participate.MethodsThe study population included 102 children aged 7–18 yr who had given their assent to participate in a clinical anesthesia or surgical study. Children were interviewed using a semistructured format to determine their understanding of eight core elements of disclosure for the study to which they had agreed to participate. Two independent assessors scored the children's levels of understanding of these elements.ResultsThe children's perceived level of understanding of the elements of disclosure was significantly greater than their measured understanding (7.0 ± 2.4vs.5.3 ± 2.7, 0–10 scale;P< 0.0001). Complete understanding of the elements of disclosure for all children ranged from 30.4 to 89.4%. Children aged more than 11 yr had significantly greater understanding compared with younger children, particularly with respect to understanding of the study protocol, the benefits, and the freedom to withdraw.ConclusionsChildren approached for their assent to participate in a clinical anesthesia or surgery study have limited understanding of the elements of disclosure and their role as a research participant, particularly if they are aged less than 11 yr.

ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

BackgroundThe Bullard laryngoscope is useful for the management of a variety of airway management scenarios. Without the aid of a video system, teaching laryngoscopy skills occurs with indirect feedback to the instructor. The purpose of this study was to determine if use of a video system would quicken the process of learning the Bullard laryngoscope or improve the performance (speed or success) of its use.MethodsThirty-six anesthesia providers with no previous Bullard laryngoscope experience were randomly divided into two groups: initial training (first 15 intubations) with looking directly through the eyepiece (n = 20), or with the display of the scope on a video monitor (n = 16). The subjects each then performed 15 Bullard intubations by looking directly through the eyepiece.ResultsThere was not an overall significant difference in laryngoscopy or intubation times between the groups. When only the first 15 intubations were considered, the laryngoscopy time was shorter in the video group (26 ± 24) than in the nonvideo group (32 ± 34;P< 0.04). In the first 15 patients, there were fewer single attempts at intubation (67.9%vs.80.3%;P< 0.002) and more failed intubations (17.2%vs.6.0%;P< 0.0001) in the nonvideo group.ConclusionsIn conclusion, the authors have shown that use of a video camera decreases time for laryngoscopic view and improves success rate when the Bullard laryngoscope is first being taught to experienced clinicians. However, these benefits are not evident as more experience with the Bullard laryngoscope is achieved, such that no difference in skill with the Bullard laryngoscope is discernible after 15 intubations whether a video system was used to teach this technique.

ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

BackgroundSeveral studies relating electroencephalogram parameter values to clinical endpoints using a single (mostly hypnotic) drug at relatively low levels of central nervous system depression (sedation) have been published. However, the usefulness of a parameter derived from the electroencephalogram for clinical anesthesia largely depends on its ability to predict the response to stimuli of different intensity or painfulness under a combination of a hypnotic and an (opioid) analgesic. This study was designed to evaluate the predictive performance of spectral edge frequency 95 (SEF95), BIS, and approximate entropy for the response to increasingly intense stimuli under different concentrations of both propofol and remifentanil in the therapeutic range.MethodsTen healthy male and ten healthy female volunteers were studied during coadministration of propofol and remifentanil. After having maintained a specific target concentration for 10 min, the depth of sedation–anesthesia was assessed using the responsiveness component of the Observer's Assessment of Alertness/Sedation (OAA/S) rating scale, which was modified by adding insertion of a laryngeal mask and laryngoscopy. The electroencephalogram derived parameters approximate entropy, bispectral index, and SEF95 were recorded just before sedation level was assessed.ResultsThe prediction probability values for approximate entropy were slightly, but not significantly, better than those for bispectral index, SEF95, and the combination of drug concentrations. A much lower prediction ability was observed for tolerance of airway manipulation than for hypnotic endpoints.ConclusionApproximate entropy revealed informations on hypnotic and analgesic endpoints using coadministration of propofol and remifentanil comparable to bispectral index, SEF95, and the combination of drug concentrations.

ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

BackgroundOtherwise healthy children who present for elective surgery with an upper respiratory infection (URI) may be at risk for perioperative respiratory complications. This risk may be increased in children with congenital heart disease who undergo cardiac surgery while harboring a URI because of their compromised cardiopulmonary status. Therefore, this study was designed to determine the incidence of peri- and postoperative complications in children undergoing cardiac surgery while harboring a URI.MethodsThe study population consisted of 713 children scheduled to undergo cardiac surgery. Of these, 96 had symptoms of URI, and 617 were asymptomatic. Children were followed prospectively from induction of anesthesia to discharge from the hospital to determine the incidence of postoperative respiratory, cardiovascular, neurologic, and surgical adverse events. Duration of postoperative ventilation, time in the intensive care unit (ICU), and length of hospital stay were also recorded.ResultsChildren with URIs had a significantly higher incidence of respiratory and multiple postoperative complications than children with no URIs (29.2vs.17.3% and 25vs.10.3%, respectively;P< 0.01) and a higher incidence of postoperative bacterial infections (5.2vs.1.0%;P= 0.01). Furthermore, logistic regression indicated that the presence of a URI was an independent risk factor for multiple postoperative complications and postoperative infections in children undergoing open heart surgery. Children with URIs also stayed longer in the intensive care unit than children with no URIs (75.9 ± 89.8 hvs.57.7 ± 63.8, respectively;P< 0.01). However, the overall length of hospital stay was not significantly different (8.4vs.7.8 days, URIvs.non-URI groups;P> 0.05).ConclusionsThe presence of a URI was predictive of postoperative infection and multiple complications in children presenting for cardiac surgery. Despite this, the presence of a URI does not appear to affect the patient's overall length of hospital stay nor the development of long-term sequelae.

ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

BackgroundNitrous oxide (N2O) and propofol exhibit directionally opposite effects on the cerebral circulation, vasodilation and vasoconstriction, respectively. The authors investigated an interaction between the two anesthetic agents on the dynamic cerebrovascular response to step changes in end-tidal pressure of carbon dioxide (Petco2) in humans.MethodsParticipants with no systemic diseases were allocated into two groups, each of which was anesthetized sequentially with two protocols. Patients in group 1 were anesthetized with 30% O2+ 70% N2O. A continuous intravenous infusion of propofol (7–10 mg · kg−1· h−1) was then added to the N2O. Patients in group 2 were anesthetized first with continuous infusion of propofol (10 mg · kg−1· h−1), and then 30% O2+ 70% N2O was added to the propofol anesthesia. Using transcranial Doppler ultrasonography, blood flow velocity at the middle cerebral artery (FVMCA) was measured during a step increase (on-response) followed by a step decrease (off-response) in Petco2, with Petco2ranging between approximately 28 and 50 mmHg. The dynamic FVMCA–Petco2relationship was analyzed using a mathematical model that was characterized with a pure time delay, and a time constant and a gain each for the on- or off-response.ResultsThe addition of propofol to the N2O anesthesia increased the on-response time constant (P< 0.01), whereas the addition of N2O to the propofol anesthesia increased the time constants for on- (P< 0.01) and off-responses (P< 0.05). However, the addition of either anesthetic did not affect the gains.ConclusionsPropofol and N2O, when one is added to the other, produce similar dynamic FVMCAresponses to sudden changes in Petco2. Addition of each anesthetic slows the dynamic response and produces the response whose magnitude is proportional to the baseline FVMCA.

ISSN:0003-3022    

出版商:OVID    

年代:2003

数据来源: OVID