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1.
Cochrane Database Syst Rev ; (4): CD001048, 2004 Oct 18.
Article in English | MEDLINE | ID: mdl-15495003

ABSTRACT

BACKGROUND: Induced hypothermia has been used in the treatment of head injury for many years. Encouraging results from small trials and laboratory studies led to renewed interest in the area and some larger trials. OBJECTIVES: To estimate the effects of mild induced hypothermia in moderate and severe head injury on mortality, long-term functional outcome, complications, and short-term control of intracranial pressure (ICP). SEARCH STRATEGY: We searched the Injuries Group Specialised register (last searched in 2001), MEDLINE, EMBASE and the Cochrane Controlled Trials Register. We handsearched conference proceedings and checked reference lists of relevant articles, including a systematic review published in 2003. SELECTION CRITERIA: Randomised controlled trials of mild hypothermia to 34-35 masculine Celsius for at least 12 hours versus control (open or normothermia) in patients with any closed head injury requiring hospitalisation. Two reviewers independently assessed all trials. DATA COLLECTION AND ANALYSIS: Data on death, Glasgow outcome scale, complications and ICP were sought and extracted, either from published material or by contacting the investigators. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each trial on an intention-to-treat basis. Quantitative synthesis of data on complications other than pneumonia or ICP was not attempted. Trials of immediate and deferred hypothermia were analysed separately. MAIN RESULTS: We found 14 trials with 1094 participants. Active immediate hypothermia was associated with an OR for death of 0.80, (1061 patients, OR 0.80, 95% CI 0.61 to 1.04), and 0.75 for odds of being dead or severely disabled, (746 patients, OR 0.75, 95% CI 0.56 to 1.00). Hypothermia treatment was associated with a statistically significant increase in odds of pneumonia (281 patients, OR 1.95, 95% CI 1.18 to 3.23). The trial of deferred hypothermia (33 patients) reported a huge but not statistically significant reduction in the odds of death at six months, (OR 0.21, 95% CI 0.04 to 1.05). For death or severe disability, deferred hypothermia was associated with an OR of 0.10 (95% CI 0.01 to 1.00). REVIEWERS' CONCLUSIONS: There is no evidence that hypothermia is beneficial in the treatment of head injury. The earlier, encouraging, trial results have not been repeated in larger trials. The reasons for this are unclear. Hypothermia increases the risk of pneumonia and has other potentially harmful side-effects. Therefore, it would seem inappropriate to use this intervention outside of controlled trials in subgroups of patients for whom there is good reason to think the treatment would be beneficial.


Subject(s)
Craniocerebral Trauma/therapy , Hypothermia, Induced , Craniocerebral Trauma/mortality , Humans , Hypothermia, Induced/adverse effects , Randomized Controlled Trials as Topic
2.
Cochrane Database Syst Rev ; (1): CD001048, 2002.
Article in English | MEDLINE | ID: mdl-11869586

ABSTRACT

BACKGROUND: Induced hypothermia has been used in the treatment of head injury for many years. Encouraging results from small trials and laboratory studies led to renewed interest in the area and some larger trials. OBJECTIVES: To estimate the effects of mild induced hypothermia in moderate and severe head injury on mortality, long-term functional outcome, complications, and short-term control of intracranial pressure (ICP). SEARCH STRATEGY: We searched the Injuries Group Specialised register (last searched in 2001), Medline, EMBASE and the Cochrane Controlled Trials Register. We handsearched conference proceedings and checked reference lists of relevant articles. SELECTION CRITERIA: Randomised controlled trials of mild hypothermia to 34-35 Celsius for a t least 12 hours versus control (open or normothermia) in patients with any closed head injury requiring hospitalisation. Two reviewers independently assessed all trials. DATA COLLECTION AND ANALYSIS: Data on death, Glasgow Outcome Scale, complications and ICP were sought and extracted, either from published material or by contacting the investigators. Odds ratios and 95% confidence intervals were calculated for each trial on an intention-to-treat basis. Quantitative synthesis of data on complications other than pneumonia or ICP was not attempted. Trials of immediate and deferred hypothermia were analysed separately. MAIN RESULTS: We found 12 trials with 812 participants. Active immediate hypothermia was associated with an odds ratio for death of 0.88, (771 patients, OR 0.88, 95% CI 0.63 to 1.21), and 0.75 for odds of being dead or severely disabled, (746 patients, OR 0.75, 95% CI 0.56 to 1.00). Hypothermia treatment was associated with a statistically significant increase in odds of pneumonia (281 patients, OR 1.95, 95% CI 1.18 to 3.23). The trial of deferred hypothermia (33 patients) reported a huge but not statistically significant reduction in the odds of death at 6 months, (OR 0.21, 95% CI 0.04 to 1.05). For death or severe disability deferred hypothermia was associated with an odds ratio of 0.10 (95% CI 0.01 to 1.00). REVIEWER'S CONCLUSIONS: There is no evidence that hypothermia is beneficial in the treatment of head injury. The earlier, encouraging, trial results have not been repeated in larger trials. The reasons for this are unclear. Hypothermia increases the risk of pneumonia and has other potentially harmful side effects. Therefore, it would seem inappropriate to use this intervention outside of controlled trials in subgroups of patients for whom there is good reason to think the treatment would be beneficial.


Subject(s)
Craniocerebral Trauma/therapy , Hypothermia, Induced , Humans
3.
Sleep Med ; 2(5): 389-96, 2001 Sep.
Article in English | MEDLINE | ID: mdl-14592388

ABSTRACT

OBJECTIVE: Comparison of polysomnography (PSG)-derived sleep parameters (total sleep time, sleep efficiency, and number of awakenings) to those derived from actigraphy and subjective questionnaires. BACKGROUND: Actigraphy is commonly used to assist sleep specialists in the diagnosis of various sleep and circadian-rhythm disorders. However, few validation studies incorporate large sample sizes, typical sleep clinic patients, or comparisons with subjective reports of sleep parameters. METHODS: Clinical series with 100 consecutive sleep-disordered patients (69 men, 31 women, mean age of 49+/-14.7 years) at a tertiary sleep disorders center. Sensitivity, specificity, and accuracy measures were obtained from epoch-by-epoch comparison of PSG and actigraphic data. Subjective sleep parameter data were derived from questionnaires given to subjects in the morning following their recording night. RESULTS: We found that total sleep time and sleep efficiency did not significantly differ between PSG data and the combined data obtained from actigraphy and subjective reports. Using a high-threshold (low-wake-sensitivity) actigraphic algorithm, the number of awakenings was not significantly different from those detected by PSG. CONCLUSIONS: We recommend the use of subjective data as an adjunct to actigraphic data in estimating total sleep time and sleep efficiency in sleep-disordered patients, especially those with disorders of excessive somnolence.

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