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Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation

Standard

Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation : The SETPOINT2 Randomized Clinical Trial. / Bösel, Julian; Niesen, Wolf-Dirk; Salih, Farid; Morris, Nicholas A; Ragland, Jeremy T; Gough, Bryan; Schneider, Hauke; Neumann, Jan-Oliver; Hwang, David Y; Kantamneni, Phani; James, Michael L; Freeman, William D; Rajajee, Venkatakrishna; Rao, Chethan Venkatasubba; Nair, Deepak; Benner, Laura; Meis, Jan; Klose, Christina; Kieser, Meinhard; Suarez, José I; Schönenberger, Silvia; Seder, David B; SETPOINT2 and the IGNITE Study Groups.

in: JAMA-J AM MED ASSOC, Jahrgang 327, Nr. 19, 17.05.2022, S. 1899-1909.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Bösel, J, Niesen, W-D, Salih, F, Morris, NA, Ragland, JT, Gough, B, Schneider, H, Neumann, J-O, Hwang, DY, Kantamneni, P, James, ML, Freeman, WD, Rajajee, V, Rao, CV, Nair, D, Benner, L, Meis, J, Klose, C, Kieser, M, Suarez, JI, Schönenberger, S, Seder, DB & SETPOINT2 and the IGNITE Study Groups 2022, 'Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial', JAMA-J AM MED ASSOC, Jg. 327, Nr. 19, S. 1899-1909. https://doi.org/10.1001/jama.2022.4798

APA

Bösel, J., Niesen, W-D., Salih, F., Morris, N. A., Ragland, J. T., Gough, B., Schneider, H., Neumann, J-O., Hwang, D. Y., Kantamneni, P., James, M. L., Freeman, W. D., Rajajee, V., Rao, C. V., Nair, D., Benner, L., Meis, J., Klose, C., Kieser, M., ... SETPOINT2 and the IGNITE Study Groups (2022). Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial. JAMA-J AM MED ASSOC, 327(19), 1899-1909. https://doi.org/10.1001/jama.2022.4798

Vancouver

Bösel J, Niesen W-D, Salih F, Morris NA, Ragland JT, Gough B et al. Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial. JAMA-J AM MED ASSOC. 2022 Mai 17;327(19):1899-1909. https://doi.org/10.1001/jama.2022.4798

Bibtex

@article{be9b8c76fdeb4813a425866bbe274614,
title = "Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial",
abstract = "IMPORTANCE: Many patients with severe stroke have impaired airway protective reflexes, resulting in prolonged invasive mechanical ventilation.OBJECTIVE: To test whether early vs standard tracheostomy improved functional outcome among patients with stroke receiving mechanical ventilation.DESIGN, SETTING, AND PARTICIPANTS: In this randomized clinical trial, 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation were randomly assigned (1:1) to early tracheostomy (≤5 days of intubation) or ongoing ventilator weaning with standard tracheostomy if needed from day 10. Patients were randomized between July 28, 2015, and January 24, 2020, at 26 US and German neurocritical care centers. The final date of follow-up was August 9, 2020.INTERVENTIONS: Patients were assigned to an early tracheostomy strategy (n = 188) or to a standard tracheostomy (control group) strategy (n = 194).MAIN OUTCOMES AND MEASURES: The primary outcome was functional outcome at 6 months, based on the modified Rankin Scale score (range, 0 [best] to 6 [worst]) dichotomized to a score of 0 (no disability) to 4 (moderately severe disability) vs 5 (severe disability) or 6 (death).RESULTS: Among 382 patients randomized (median age, 59 years; 49.8% women), 366 (95.8%) completed the trial with available follow-up data on the primary outcome (177 patients [94.1%] in the early group; 189 patients [97.4%] in the standard group). A tracheostomy (predominantly percutaneously) was performed in 95.2% of the early tracheostomy group in a median of 4 days after intubation (IQR, 3-4 days) and in 67% of the control group in a median of 11 days after intubation (IQR, 10-12 days). The proportion without severe disability (modified Rankin Scale score, 0-4) at 6 months was not significantly different in the early tracheostomy vs the control group (43.5% vs 47.1%; difference, -3.6% [95% CI, -14.3% to 7.2%]; adjusted odds ratio, 0.93 [95% CI, 0.60-1.42]; P = .73). Of the serious adverse events, 5.0% (6 of 121 reported events) in the early tracheostomy group vs 3.4% (4 of 118 reported events) were related to tracheostomy.CONCLUSIONS AND RELEVANCE: Among patients with severe stroke receiving mechanical ventilation, a strategy of early tracheostomy, compared with a standard approach to tracheostomy, did not significantly improve the rate of survival without severe disability at 6 months. However, the wide confidence intervals around the effect estimate may include a clinically important difference, so a clinically relevant benefit or harm from a strategy of early tracheostomy cannot be excluded.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02377167.",
keywords = "Airway Management, Female, Humans, Male, Middle Aged, Recovery of Function, Reflex, Abnormal, Respiration, Artificial/adverse effects, Respiratory Tract Diseases/etiology, Stroke/complications, Time Factors, Tracheostomy/adverse effects, Treatment Outcome, Ventilator Weaning/methods",
author = "Julian B{\"o}sel and Wolf-Dirk Niesen and Farid Salih and Morris, {Nicholas A} and Ragland, {Jeremy T} and Bryan Gough and Hauke Schneider and Jan-Oliver Neumann and Hwang, {David Y} and Phani Kantamneni and James, {Michael L} and Freeman, {William D} and Venkatakrishna Rajajee and Rao, {Chethan Venkatasubba} and Deepak Nair and Laura Benner and Jan Meis and Christina Klose and Meinhard Kieser and Suarez, {Jos{\'e} I} and Silvia Sch{\"o}nenberger and Seder, {David B} and {SETPOINT2 and the IGNITE Study Groups} and Stefan Kluge",
year = "2022",
month = may,
day = "17",
doi = "10.1001/jama.2022.4798",
language = "English",
volume = "327",
pages = "1899--1909",
journal = "JAMA-J AM MED ASSOC",
issn = "0098-7484",
publisher = "American Medical Association",
number = "19",

}

RIS

TY - JOUR

T1 - Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation

T2 - The SETPOINT2 Randomized Clinical Trial

AU - Bösel, Julian

AU - Niesen, Wolf-Dirk

AU - Salih, Farid

AU - Morris, Nicholas A

AU - Ragland, Jeremy T

AU - Gough, Bryan

AU - Schneider, Hauke

AU - Neumann, Jan-Oliver

AU - Hwang, David Y

AU - Kantamneni, Phani

AU - James, Michael L

AU - Freeman, William D

AU - Rajajee, Venkatakrishna

AU - Rao, Chethan Venkatasubba

AU - Nair, Deepak

AU - Benner, Laura

AU - Meis, Jan

AU - Klose, Christina

AU - Kieser, Meinhard

AU - Suarez, José I

AU - Schönenberger, Silvia

AU - Seder, David B

AU - SETPOINT2 and the IGNITE Study Groups

AU - Kluge, Stefan

PY - 2022/5/17

Y1 - 2022/5/17

N2 - IMPORTANCE: Many patients with severe stroke have impaired airway protective reflexes, resulting in prolonged invasive mechanical ventilation.OBJECTIVE: To test whether early vs standard tracheostomy improved functional outcome among patients with stroke receiving mechanical ventilation.DESIGN, SETTING, AND PARTICIPANTS: In this randomized clinical trial, 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation were randomly assigned (1:1) to early tracheostomy (≤5 days of intubation) or ongoing ventilator weaning with standard tracheostomy if needed from day 10. Patients were randomized between July 28, 2015, and January 24, 2020, at 26 US and German neurocritical care centers. The final date of follow-up was August 9, 2020.INTERVENTIONS: Patients were assigned to an early tracheostomy strategy (n = 188) or to a standard tracheostomy (control group) strategy (n = 194).MAIN OUTCOMES AND MEASURES: The primary outcome was functional outcome at 6 months, based on the modified Rankin Scale score (range, 0 [best] to 6 [worst]) dichotomized to a score of 0 (no disability) to 4 (moderately severe disability) vs 5 (severe disability) or 6 (death).RESULTS: Among 382 patients randomized (median age, 59 years; 49.8% women), 366 (95.8%) completed the trial with available follow-up data on the primary outcome (177 patients [94.1%] in the early group; 189 patients [97.4%] in the standard group). A tracheostomy (predominantly percutaneously) was performed in 95.2% of the early tracheostomy group in a median of 4 days after intubation (IQR, 3-4 days) and in 67% of the control group in a median of 11 days after intubation (IQR, 10-12 days). The proportion without severe disability (modified Rankin Scale score, 0-4) at 6 months was not significantly different in the early tracheostomy vs the control group (43.5% vs 47.1%; difference, -3.6% [95% CI, -14.3% to 7.2%]; adjusted odds ratio, 0.93 [95% CI, 0.60-1.42]; P = .73). Of the serious adverse events, 5.0% (6 of 121 reported events) in the early tracheostomy group vs 3.4% (4 of 118 reported events) were related to tracheostomy.CONCLUSIONS AND RELEVANCE: Among patients with severe stroke receiving mechanical ventilation, a strategy of early tracheostomy, compared with a standard approach to tracheostomy, did not significantly improve the rate of survival without severe disability at 6 months. However, the wide confidence intervals around the effect estimate may include a clinically important difference, so a clinically relevant benefit or harm from a strategy of early tracheostomy cannot be excluded.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02377167.

AB - IMPORTANCE: Many patients with severe stroke have impaired airway protective reflexes, resulting in prolonged invasive mechanical ventilation.OBJECTIVE: To test whether early vs standard tracheostomy improved functional outcome among patients with stroke receiving mechanical ventilation.DESIGN, SETTING, AND PARTICIPANTS: In this randomized clinical trial, 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation were randomly assigned (1:1) to early tracheostomy (≤5 days of intubation) or ongoing ventilator weaning with standard tracheostomy if needed from day 10. Patients were randomized between July 28, 2015, and January 24, 2020, at 26 US and German neurocritical care centers. The final date of follow-up was August 9, 2020.INTERVENTIONS: Patients were assigned to an early tracheostomy strategy (n = 188) or to a standard tracheostomy (control group) strategy (n = 194).MAIN OUTCOMES AND MEASURES: The primary outcome was functional outcome at 6 months, based on the modified Rankin Scale score (range, 0 [best] to 6 [worst]) dichotomized to a score of 0 (no disability) to 4 (moderately severe disability) vs 5 (severe disability) or 6 (death).RESULTS: Among 382 patients randomized (median age, 59 years; 49.8% women), 366 (95.8%) completed the trial with available follow-up data on the primary outcome (177 patients [94.1%] in the early group; 189 patients [97.4%] in the standard group). A tracheostomy (predominantly percutaneously) was performed in 95.2% of the early tracheostomy group in a median of 4 days after intubation (IQR, 3-4 days) and in 67% of the control group in a median of 11 days after intubation (IQR, 10-12 days). The proportion without severe disability (modified Rankin Scale score, 0-4) at 6 months was not significantly different in the early tracheostomy vs the control group (43.5% vs 47.1%; difference, -3.6% [95% CI, -14.3% to 7.2%]; adjusted odds ratio, 0.93 [95% CI, 0.60-1.42]; P = .73). Of the serious adverse events, 5.0% (6 of 121 reported events) in the early tracheostomy group vs 3.4% (4 of 118 reported events) were related to tracheostomy.CONCLUSIONS AND RELEVANCE: Among patients with severe stroke receiving mechanical ventilation, a strategy of early tracheostomy, compared with a standard approach to tracheostomy, did not significantly improve the rate of survival without severe disability at 6 months. However, the wide confidence intervals around the effect estimate may include a clinically important difference, so a clinically relevant benefit or harm from a strategy of early tracheostomy cannot be excluded.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02377167.

KW - Airway Management

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Recovery of Function

KW - Reflex, Abnormal

KW - Respiration, Artificial/adverse effects

KW - Respiratory Tract Diseases/etiology

KW - Stroke/complications

KW - Time Factors

KW - Tracheostomy/adverse effects

KW - Treatment Outcome

KW - Ventilator Weaning/methods

U2 - 10.1001/jama.2022.4798

DO - 10.1001/jama.2022.4798

M3 - SCORING: Journal article

C2 - 35506515

VL - 327

SP - 1899

EP - 1909

JO - JAMA-J AM MED ASSOC

JF - JAMA-J AM MED ASSOC

SN - 0098-7484

IS - 19

ER -