human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Whether early percutaneous tracheotomy in patients who require prolonged mechanical ventilation can shorten mechanical ventilation duration and lower mortality remains controversial . OBJECTIVE To compare the outcomes of severely ill patients who require prolonged mechanical ventilation r and omly assigned to early percutaneous tracheotomy or prolonged intubation .  DESIGN Prospect i ve , r and omized , controlled , single-center trial ( Clinical Trials.gov registration number : NCT00347321 ) . SETTING Academic center . PATIENTS 216 adults requiring mechanical ventilation 4 or more days after cardiac surgery . INTERVENTION Immediate early percutaneous tracheotomy or prolonged intubation with tracheotomy 15 days after r and omization . MEASUREMENTS The primary end point was the number of ventilator-free days during the first 60 days after r and omization . Secondary outcomes included 28- , 60- , or 90-day mortality rates ; duration s of mechanical ventilation , intensive care unit stay , and hospitalization ; sedative , analgesic , and neuroleptic use ; ventilator-associated pneumonia rate ; unscheduled extubations ; comfort and ease of care ; and long-term health-related quality of life ( HRQoL ) and psychosocial evaluations . RESULTS There was no difference in ventilator-free days during the first 60 days after r and omization between early percutaneous tracheotomy and prolonged intubation groups ( mean , 30.4 days [ SD , 22.4 ] vs. 28.3 days [ SD , 23.7 ] , respectively ; absolute difference , 2.1 days [ 95 % CI , -4.1 to 8.3 days ] ) nor in 28- , 60- , or 90-day mortality rates ( 16 % vs. 21 % , 26 % vs. 28 % , and 30 % vs. 30 % , respectively ) . The duration s of mechanical ventilation and hospitalization , as well as frequencies of ventilator-associated pneumonia and other severe infections , were also similar . However , early percutaneous tracheotomy was associated with less intravenous sedation ; less time of heavy sedation ; less haloperidol use for agitation , delirium , or both ; fewer unscheduled extubations ; better comfort and ease of care ; and earlier resumption of oral nutrition . After a median follow-up of 873 days , between-group survival , psychosocial evaluations , and HRQoL were similar . LIMITATION The prolonged intubation group had more ventilator-free days during days 1 to 60 than what was hypothesized ( mean , 23.0 days [ SD , 17.0 ] ) . CONCLUSION Early tracheotomy provided no benefit in terms of mechanical ventilation and length of hospital stay , rates of mortality or infectious complications , and long-term HRQoL for patients who require prolonged mechanical ventilation after cardiac surgery . However , the well-tolerated procedure was associated with less sedation , better comfort , and earlier resumption of autonomy . PRIMARY FUNDING SOURCE French Ministry of Health OBJECTIVE In the past , the authors performed a comprehensive literature review to identify all r and omized controlled trials assessing the impact of  early tracheostomy on severe brain injury outcomes . The search produced only two trials , one by Sugerman and another by Bouderka . SUBJECTS AND METHODS The current authors initiated an Institutional Review Board-approved severe brain injury r and omized trial to evaluate the impact of early tracheostomy on ventilator-associated pneumonia rates , intensive care unit (ICU)/ventilator days , and hospital mortality . Current study results were compared with the other r and omized trials and a meta- analysis was performed . RESULTS Early tracheostomy pneumonia rates were Sugerman-48.6 % , Bouderka-58.1 % , and current study -46.7 % . No early tracheostomy pneumonia rates were Sugerman-53.1 % , Bouderka-61.3 % , and current study -44.4 % . Pneumonia rate meta- analysis showed no difference for early tracheostomy and no early tracheostomy ( OR 0.89 ; p = 0.71 ) . Early tracheostomy ICU/ventilator days were Sugerman-16 ± 5.9 , Bouderka-14.5 ± 7.3 , and current study -14.1 ± 5.7 . No early tracheostomy ICU/ventilator days were Sugerman-19 ± 11.3 , Bouderka-17.5 ± 10.6 , and current study -17 ± 5.4 . ICU/ventilator day meta- analysis showed 2.9 fewer days with early tracheostomy ( p = 0.02 ) . Early tracheostomy mortality rates were Sugerman-14.3 % , Bouderka-38.7 % , and current study -0 % . No early tracheostomy mortality rates were Sugerman-3.2 % , Bouderka-22.6 % , and current study -0 % . R and omized trial mortality rate meta- analysis showed a higher rate for early tracheostomy ( OR 2.68 ; p = 0.05 ) . Because the r and omized trials were small , a literature assessment was undertaken to find all retrospective studies describing the association of early tracheostomy on severe brain injury hospital mortality . The review produced five retrospective studies , with a total of 3,356 patients . Retrospective study mortality rate meta- analysis demonstrated a larger mortality for early tracheostomy ( OR 1.97 ; p < 0.0001 ) . CONCLUSION For severe brain injury , analyses indicate that ventilator-associated pneumonia rates are not decreased with early tracheostomy . Further , this study implies that mechanical ventilation is reduced with early tracheostomy . Both the r and omized trial and retrospective meta- analysis indicate that risk for hospital death increases with early tracheostomy . Findings imply that early tracheostomy for severe brain injury is not a prudent routine policy During the last 22 months , a total number of 85 tracheostomies have been performed in our ICU , 40 of which have been surgical , and 45 percutaneous to patients under mechanical ventilation .  This period has coincided with the learning process of the technique of percutaneous tracheostomy by our staff . The choice of the type of tracheostomy was not taken at r and om , but guided by clinical criteria . Our results confirm a lower rate of infection of the estoma in percutaneous tracheostomies than in surgical ones ( 5 percutaneous and 29 surgical , p < 0.001 ) . The most serious complication was a tracheal perforation in a percutaneous tracheostomy . 17 of the 85 patients died in ICU , and 33 of the 68 patients who were discharged , survived the hospital , 27 of whom left with a closed tracheostomy . The other 6 permanent tracheostomies had been performed surgically and corresponded to 4 patients with worsening EPOC , one neurological patient and another patient suffering from anoxic encephalopathy . No  percutaneous tracheostomy  was left as permanent . The patients who benefitted especially from the tracheostomy presented the following characteristics :  acute respiratory insufficiency  with prolonged intubation , neurological patients , and worsening EPOC . The  tracheostomy in persistent vegetative status allowed their moving to more suitable areas . Our study proves the existence of a learning curve in the practice of  percutaneous tracheostomy . This aspect should be taken into account by other groups who are interested in including this technique in their services Objective Although several advantages are attributed to tracheotomy in ICU patients requiring mechanical ventilation ( MV ) , true benefits and the optimal timing of tracheotomy remain controversial . In this study , we compared early tracheotomy ( ET ) with prolonged intubation ( PI ) in severely ill patients requiring prolonged MV . Design Prospect i ve , r and omized study . Setting Twenty-five medical and surgical ICUs in France . Patients Patients expected to require MV > 7 days . Measurements and results Patients were r and omised to either ( open or percutaneous ) ET within 4 days or PI . The primary end-point was 28-day mortality . Secondary end-points were : the incidence of ICU-acquired pneumonia , number of d1-d28 ventilator-free days , time spent in the ICU , 60-day mortality , number of septic episodes , amount of sedation , comfort and laryngeal and tracheal complications .  A sample size of 470 patients was considered necessary to obtain a reduction from 45 to 32 % in 28-day mortality . After 30 months , 123 patients had been included ( ET = 61 , PI = 62 ) in 25 centres and the study was prematurely closed . All group characteristics were similar upon admission to ICU . No difference was found between the two groups for any of the primary or secondary end-points . Greater comfort was the sole benefit afforded by tracheotomy after subjective self- assessment by patients . Conclusions The trial did not demonstrate any major benefit of tracheotomy in a general population of ICU patients , as suggested in a previous meta- analysis , but was underpowered to draw any firm conclusions . The potential advantage of ET may be restricted to selected groups of patients Introduction We investigated the potential benefits of early tracheotomy performed before day eight of mechanical ventilation ( MV ) compared with late tracheotomy ( from day 14 if it still indicated ) in reducing mortality , days of MV , days of sedation and ICU length of stay ( LOS ) . Methods R and omized controlled trial ( RCT ) including all-consecutive ICU admitted patients requiring seven or more days of MV . Between days five to seven of MV , before r and omization , the attending physician ( AP ) was consulted about the expected duration of  MV  and acceptance of tracheotomy according to r and omization . Only accepted patients received tracheotomy as result of r and omization . An intention to treat analysis was performed including patients accepted for the AP and those rejected without exclusion criteria . Results A total of 489 patients were included in the RCT . Of 245 patients r and omized to the early group , the procedure was performed for 167 patients ( 68.2 % ) whereas in the 244 patients r and omized to the late group was performed for 135 patients ( 55.3 % ) ( P < 0.004 ) . Mortality at day 90 was similar in both groups ( 25.7 % versus 29.9 % ) , but duration of sedation was shorter in the early tracheotomy group median 11 days ( range 2 to 92 ) days compared to 14 days ( range 0 to 79 ) in the late group ( P < 0.02 ) . The AP accepted the protocol of r and omization in 205 cases ( 42 % ) , 101 were included in early group and 104 in the late group . In these subgroup of patients ( per- protocol analysis ) no differences existed in mortality at day 90 between the two groups , but the early group had more ventilator-free days , less duration of sedation and less LOS , than the late group . Conclusions This study shows that early tracheotomy reduces the days of sedation in patients undergoing MV , but was underpowered to prove any other benefit . In those patients selected by their attending physicians as potential c and i date s for a tracheotomy , an early procedure can lessen the days of MV , the days of sedation and LOS . However , the imprecision of physicians to select patients who will require prolonged MV challenges the potential benefits of early tracheotomy . Trial registration Controlled-Trials.com IS RCT N22208087 . Registered 27 March 2014 During a 12‐month period , 264 patients with multiple injuries who required mechanical ventilation were admitted to the surgical intensive care unit . One hundred twenty patients ( 46 % ) were disengaged from the ventilator , and 38 patients ( 14 % ) died . Of the remaining 106 patients ( 40 % ) 51 patients ( group I ) were to receive tracheostomy within 1 to 7 days , and 55 patients ( group II ) underwent late ( 8 or more days after admission ) tracheostomy . Multiple variables in four categories ( admission , operative , ventilatory , and outcome ) were analyzed prospect ively to define the impact that early tracheostomy had on duration of mechanical ventilation , intensive care stay , and hospital stay . Morbidity and mortality rates of the procedures were assessed . Early tracheostomy , in a homogeneous group of critically ill patients , is associated with a significant decrease in duration of mechanical ventilation , as well as shorter intensive care unit and hospital stays , compared with translaryngeal endotracheal intubation . There were no deaths attributable to tracheostomy , and overall morbidity of the procedures was 4 % . We conclude that early tracheostomy has an overall risk equivalent to that of endotracheal intubation . Furthermore , early tracheostomy  shortens days on the ventilator and intensive care unit and hospital days and should be considered for patients in the intensive care unit at risk for more than 7 days of intubation One of the problems of prolonged ventilatory therapy in acute respiratory failure ( ARF ) is the need to choose between tracheostomy after 48 to 72 hours of translaryngeal ( TL ) tracheal intubation or the continuous use of the TL tube for a period of 10 days . Too often the choice has been based on retrospective studies or personal preference . To investigate this problem prospect ively , 52 adults in ARF were divided sequentially into 2 groups on their 3rd day of TL intubation . Patients in group I ( G-I ) retained the TL tube for a total of 11 days ; those in group II ( G-II ) were tracheostomized on the 3rd day . The following factors were used to evaluate the efficiency and complications 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Whether early percutaneous tracheotomy in patients who require prolonged mechanical ventilation can shorten mechanical ventilation duration and lower mortality remains controversial . OBJECTIVE To compare the outcomes of severely ill patients who require prolonged mechanical ventilation r and omly assigned to early percutaneous tracheotomy or prolonged intubation .  DESIGN Prospect i ve , r and omized , controlled , single-center trial ( Clinical Trials.gov registration number : NCT00347321 ) . SETTING Academic center . PATIENTS 216 adults requiring mechanical ventilation 4 or more days after cardiac surgery . INTERVENTION Immediate early percutaneous tracheotomy or prolonged intubation with tracheotomy 15 days after r and omization . MEASUREMENTS The primary end point was the number of ventilator-free days during the first 60 days after r and omization . Secondary outcomes included 28- , 60- , or 90-day mortality rates ; duration s of mechanical ventilation , intensive care unit stay , and hospitalization ; sedative , analgesic , and neuroleptic use ; ventilator-associated pneumonia rate ; unscheduled extubations ; comfort and ease of care ; and long-term health-related quality of life ( HRQoL ) and psychosocial evaluations . RESULTS There was no difference in ventilator-free days during the first 60 days after r and omization between early percutaneous tracheotomy and prolonged intubation groups ( mean , 30.4 days [ SD , 22.4 ] vs. 28.3 days [ SD , 23.7 ] , respectively ; absolute difference , 2.1 days [ 95 % CI , -4.1 to 8.3 days ] ) nor in 28- , 60- , or 90-day mortality rates ( 16 % vs. 21 % , 26 % vs. 28 % , and 30 % vs. 30 % , respectively ) . The duration s of mechanical ventilation and hospitalization , as well as frequencies of ventilator-associated pneumonia and other severe infections , were also similar . However , early percutaneous tracheotomy was associated with less intravenous sedation ; less time of heavy sedation ; less haloperidol use for agitation , delirium , or both ; fewer unscheduled extubations ; better comfort and ease of care ; and earlier resumption of oral nutrition . After a median follow-up of 873 days , between-group survival , psychosocial evaluations , and HRQoL were similar . LIMITATION The prolonged intubation group had more ventilator-free days during days 1 to 60 than what was hypothesized ( mean , 23.0 days [ SD , 17.0 ] ) . CONCLUSION Early tracheotomy provided no benefit in terms of mechanical ventilation and length of hospital stay , rates of mortality or infectious complications , and long-term HRQoL for patients who require prolonged mechanical ventilation after cardiac surgery . However , the well-tolerated procedure was associated with less sedation , better comfort , and earlier resumption of autonomy . PRIMARY FUNDING SOURCE French Ministry of Health OBJECTIVE In the past , the authors performed a comprehensive literature review to identify all r and omized controlled trials assessing the impact of  early tracheostomy on severe brain injury outcomes . The search produced only two trials , one by Sugerman and another by Bouderka . SUBJECTS AND METHODS The current authors initiated an Institutional Review Board-approved severe brain injury r and omized trial to evaluate the impact of early tracheostomy on ventilator-associated pneumonia rates , intensive care unit (ICU)/ventilator days , and hospital mortality . Current study results were compared with the other r and omized trials and a meta- analysis was performed . RESULTS Early tracheostomy pneumonia rates were Sugerman-48.6 % , Bouderka-58.1 % , and current study -46.7 % . No early tracheostomy pneumonia rates were Sugerman-53.1 % , Bouderka-61.3 % , and current study -44.4 % . Pneumonia rate meta- analysis showed no difference for early tracheostomy and no early tracheostomy ( OR 0.89 ; p = 0.71 ) . Early tracheostomy ICU/ventilator days were Sugerman-16 ± 5.9 , Bouderka-14.5 ± 7.3 , and current study -14.1 ± 5.7 . No early tracheostomy ICU/ventilator days were Sugerman-19 ± 11.3 , Bouderka-17.5 ± 10.6 , and current study -17 ± 5.4 . ICU/ventilator day meta- analysis showed 2.9 fewer days with early tracheostomy ( p = 0.02 ) . Early tracheostomy mortality rates were Sugerman-14.3 % , Bouderka-38.7 % , and current study -0 % . No early tracheostomy mortality rates were Sugerman-3.2 % , Bouderka-22.6 % , and current study -0 % . R and omized trial mortality rate meta- analysis showed a higher rate for early tracheostomy ( OR 2.68 ; p = 0.05 ) . Because the r and omized trials were small , a literature assessment was undertaken to find all retrospective studies describing the association of early tracheostomy on severe brain injury hospital mortality . The review produced five retrospective studies , with a total of 3,356 patients . Retrospective study mortality rate meta- analysis demonstrated a larger mortality for early tracheostomy ( OR 1.97 ; p < 0.0001 ) . CONCLUSION For severe brain injury , analyses indicate that ventilator-associated pneumonia rates are not decreased with early tracheostomy . Further , this study implies that mechanical ventilation is reduced with early tracheostomy . Both the r and omized trial and retrospective meta- analysis indicate that risk for hospital death increases with early tracheostomy . Findings imply that early tracheostomy for severe brain injury is not a prudent routine policy During the last 22 months , a total number of 85 tracheostomies have been performed in our ICU , 40 of which have been surgical , and 45 percutaneous to patients under mechanical ventilation .  This period has coincided with the learning process of the technique of percutaneous tracheostomy by our staff . The choice of the type of tracheostomy was not taken at r and om , but guided by clinical criteria . Our results confirm a lower rate of infection of the estoma in percutaneous tracheostomies than in surgical ones ( 5 percutaneous and 29 surgical , p < 0.001 ) . The most serious complication was a tracheal perforation in a percutaneous tracheostomy . 17 of the 85 patients died in ICU , and 33 of the 68 patients who were discharged , survived the hospital , 27 of whom left with a closed tracheostomy . The other 6 permanent tracheostomies had been performed surgically and corresponded to 4 patients with worsening EPOC , one neurological patient and another patient suffering from anoxic encephalopathy . No  percutaneous tracheostomy  was left as permanent . The patients who benefitted especially from the tracheostomy presented the following characteristics :  acute respiratory insufficiency  with prolonged intubation , neurological patients , and worsening EPOC . The  tracheostomy in persistent vegetative status allowed their moving to more suitable areas . Our study proves the existence of a learning curve in the practice of  percutaneous tracheostomy . This aspect should be taken into account by other groups who are interested in including this technique in their services Objective Although several advantages are attributed to tracheotomy in ICU patients requiring mechanical ventilation ( MV ) , true benefits and the optimal timing of tracheotomy remain controversial . In this study , we compared early tracheotomy ( ET ) with prolonged intubation ( PI ) in severely ill patients requiring prolonged MV . Design Prospect i ve , r and omized study . Setting Twenty-five medical and surgical ICUs in France . Patients Patients expected to require MV > 7 days . Measurements and results Patients were r and omised to either ( open or percutaneous ) ET within 4 days or PI . The primary end-point was 28-day mortality . Secondary end-points were : the incidence of ICU-acquired pneumonia , number of d1-d28 ventilator-free days , time spent in the ICU , 60-day mortality , number of septic episodes , amount of sedation , comfort and laryngeal and tracheal complications .  A sample size of 470 patients was considered necessary to obtain a reduction from 45 to 32 % in 28-day mortality . After 30 months , 123 patients had been included ( ET = 61 , PI = 62 ) in 25 centres and the study was prematurely closed . All group characteristics were similar upon admission to ICU . No difference was found between the two groups for any of the primary or secondary end-points . Greater comfort was the sole benefit afforded by tracheotomy after subjective self- assessment by patients . Conclusions The trial did not demonstrate any major benefit of tracheotomy in a general population of ICU patients , as suggested in a previous meta- analysis , but was underpowered to draw any firm conclusions . The potential advantage of ET may be restricted to selected groups of patients Introduction We investigated the potential benefits of early tracheotomy performed before day eight of mechanical ventilation ( MV ) compared with late tracheotomy ( from day 14 if it still indicated ) in reducing mortality , days of MV , days of sedation and ICU length of stay ( LOS ) . Methods R and omized controlled trial ( RCT ) including all-consecutive ICU admitted patients requiring seven or more days of MV . Between days five to seven of MV , before r and omization , the attending physician ( AP ) was consulted about the expected duration of  MV  and acceptance of tracheotomy according to r and omization . Only accepted patients received tracheotomy as result of r and omization . An intention to treat analysis was performed including patients accepted for the AP and those rejected without exclusion criteria . Results A total of 489 patients were included in the RCT . Of 245 patients r and omized to the early group , the procedure was performed for 167 patients ( 68.2 % ) whereas in the 244 patients r and omized to the late group was performed for 135 patients ( 55.3 % ) ( P < 0.004 ) . Mortality at day 90 was similar in both groups ( 25.7 % versus 29.9 % ) , but duration of sedation was shorter in the early tracheotomy group median 11 days ( range 2 to 92 ) days compared to 14 days ( range 0 to 79 ) in the late group ( P < 0.02 ) . The AP accepted the protocol of r and omization in 205 cases ( 42 % ) , 101 were included in early group and 104 in the late group . In these subgroup of patients ( per- protocol analysis ) no differences existed in mortality at day 90 between the two groups , but the early group had more ventilator-free days , less duration of sedation and less LOS , than the late group . Conclusions This study shows that early tracheotomy reduces the days of sedation in patients undergoing MV , but was underpowered to prove any other benefit . In those patients selected by their attending physicians as potential c and i date s for a tracheotomy , an early procedure can lessen the days of MV , the days of sedation and LOS . However , the imprecision of physicians to select patients who will require prolonged MV challenges the potential benefits of early tracheotomy . Trial registration Controlled-Trials.com IS RCT N22208087 . Registered 27 March 2014 During a 12‐month period , 264 patients with multiple injuries who required mechanical ventilation were admitted to the surgical intensive care unit . One hundred twenty patients ( 46 % ) were disengaged from the ventilator , and 38 patients ( 14 % ) died . Of the remaining 106 patients ( 40 % ) 51 patients ( group I ) were to receive tracheostomy within 1 to 7 days , and 55 patients ( group II ) underwent late ( 8 or more days after admission ) tracheostomy . Multiple variables in four categories ( admission , operative , ventilatory , and outcome ) were analyzed prospect ively to define the impact that early tracheostomy had on duration of mechanical ventilation , intensive care stay , and hospital stay . Morbidity and mortality rates of the procedures were assessed . Early tracheostomy , in a homogeneous group of critically ill patients , is associated with a significant decrease in duration of mechanical ventilation , as well as shorter intensive care unit and hospital stays , compared with translaryngeal endotracheal intubation . There were no deaths attributable to tracheostomy , and overall morbidity of the procedures was 4 % . We conclude that early tracheostomy has an overall risk equivalent to that of endotracheal intubation . Furthermore , early tracheostomy  shortens days on the ventilator and intensive care unit and hospital days and should be considered for patients in the intensive care unit at risk for more than 7 days of intubation One of the problems of prolonged ventilatory therapy in acute respiratory failure ( ARF ) is the need to choose between tracheostomy after 48 to 72 hours of translaryngeal ( TL ) tracheal intubation or the continuous use of the TL tube for a period of 10 days . Too often the choice has been based on retrospective studies or personal preference . To investigate this problem prospect ively , 52 adults in ARF were divided sequentially into 2 groups on their 3rd day of TL intubation . Patients in group I ( G-I ) retained the TL tube for a total of 11 days ; those in group II ( G-II ) were tracheostomized on the 3rd day . The following factors were used to evaluate the efficiency and complications 
    Output:
    