Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial
Abstract Background Weaning protocols expedite extubation in mechanically ventilated patients, yet the literature investigating the application in tracheostomized patients remains scarce. The primary objective of this parallel randomized controlled pilot trial (RCT) was to assess the feasibility and...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2018-01-01
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| Series: | Annals of Intensive Care |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13613-018-0354-1 |
| _version_ | 1818198895032795136 |
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| author | Nazzareno Fagoni Simone Piva Elena Peli Fabio Turla Elisabetta Pecci Livio Gualdoni Bertilla Fiorese Frank Rasulo Nicola Latronico |
| author_facet | Nazzareno Fagoni Simone Piva Elena Peli Fabio Turla Elisabetta Pecci Livio Gualdoni Bertilla Fiorese Frank Rasulo Nicola Latronico |
| author_sort | Nazzareno Fagoni |
| collection | DOAJ |
| description | Abstract Background Weaning protocols expedite extubation in mechanically ventilated patients, yet the literature investigating the application in tracheostomized patients remains scarce. The primary objective of this parallel randomized controlled pilot trial (RCT) was to assess the feasibility and safety of a nurse-led weaning protocol (protocol) compared to weaning based on physician’s clinical judgment (control) in tracheostomized critically ill patients. Results We enrolled 65 patients, 27 were in the protocol group and 38 in the control group. Of 27 patients in the protocol group, 1 (3.7%) died in the ICU, 24 (88.9%) were successfully weaned from tracheostomy, and 2 (7.4%) were transferred still on the ventilator. Of 38 patients in the control group, 2 (5.3%) died in the ICU, 22 (57.9%) were successfully weaned from tracheostomy, and 14 were transferred still on the ventilator (36.8%). Risk of being discharged from the ICU on the ventilator was higher in the control group (relative risk: 1.5, IC 95% 1.14–2.01). Concerning safety and feasibility, no patients were excluded after randomization. There was no crossover between the two study arms nor missing data, and no severe adverse event related to the study protocol application was recorded by the staff. Weaning time and rate of successful weaning were not different in the protocol group compared to the control group (long-rank test, p = 0.31 for MV duration, p = 0.45 for weaning time). Based on our results and assuming a 30% reduction of the weaning time for the protocol group, 280 patients would be needed for a RCT to establish efficacy. Conclusions In this pilot RCT we demonstrated that a nurse-led weaning protocol from tracheostomy was feasible and safe. A larger RCT is justified to assess efficacy. |
| first_indexed | 2024-12-12T02:13:08Z |
| format | Article |
| id | doaj.art-53e9d07c60ea4f0c8c775b9cc01a40f5 |
| institution | Directory Open Access Journal |
| issn | 2110-5820 |
| language | English |
| last_indexed | 2024-12-12T02:13:08Z |
| publishDate | 2018-01-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Annals of Intensive Care |
| spelling | doaj.art-53e9d07c60ea4f0c8c775b9cc01a40f52022-12-22T00:41:51ZengSpringerOpenAnnals of Intensive Care2110-58202018-01-018111010.1186/s13613-018-0354-1Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trialNazzareno Fagoni0Simone Piva1Elena Peli2Fabio Turla3Elisabetta Pecci4Livio Gualdoni5Bertilla Fiorese6Frank Rasulo7Nicola Latronico8Department of Anesthesia, Critical Care and Emergency, Spedali Civili University HospitalDepartment of Anesthesia, Critical Care and Emergency, Spedali Civili University HospitalDepartment of Anesthesia, Critical Care and Emergency, Spedali Civili University HospitalDepartment of Anesthesia, Critical Care and Emergency, Spedali Civili University HospitalDepartment of Anesthesia, Critical Care and Emergency, Spedali Civili University HospitalSchool of Specialty in Anesthesia, Intensive Care and Pain Medicine, University of BresciaDepartment of Anesthesia, Critical Care and Emergency, Spedali Civili University HospitalDepartment of Anesthesia, Critical Care and Emergency, Spedali Civili University HospitalDepartment of Anesthesia, Critical Care and Emergency, Spedali Civili University HospitalAbstract Background Weaning protocols expedite extubation in mechanically ventilated patients, yet the literature investigating the application in tracheostomized patients remains scarce. The primary objective of this parallel randomized controlled pilot trial (RCT) was to assess the feasibility and safety of a nurse-led weaning protocol (protocol) compared to weaning based on physician’s clinical judgment (control) in tracheostomized critically ill patients. Results We enrolled 65 patients, 27 were in the protocol group and 38 in the control group. Of 27 patients in the protocol group, 1 (3.7%) died in the ICU, 24 (88.9%) were successfully weaned from tracheostomy, and 2 (7.4%) were transferred still on the ventilator. Of 38 patients in the control group, 2 (5.3%) died in the ICU, 22 (57.9%) were successfully weaned from tracheostomy, and 14 were transferred still on the ventilator (36.8%). Risk of being discharged from the ICU on the ventilator was higher in the control group (relative risk: 1.5, IC 95% 1.14–2.01). Concerning safety and feasibility, no patients were excluded after randomization. There was no crossover between the two study arms nor missing data, and no severe adverse event related to the study protocol application was recorded by the staff. Weaning time and rate of successful weaning were not different in the protocol group compared to the control group (long-rank test, p = 0.31 for MV duration, p = 0.45 for weaning time). Based on our results and assuming a 30% reduction of the weaning time for the protocol group, 280 patients would be needed for a RCT to establish efficacy. Conclusions In this pilot RCT we demonstrated that a nurse-led weaning protocol from tracheostomy was feasible and safe. A larger RCT is justified to assess efficacy.http://link.springer.com/article/10.1186/s13613-018-0354-1TracheostomyWeaningMechanical ventilationNurse-led weaning protocol |
| spellingShingle | Nazzareno Fagoni Simone Piva Elena Peli Fabio Turla Elisabetta Pecci Livio Gualdoni Bertilla Fiorese Frank Rasulo Nicola Latronico Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial Annals of Intensive Care Tracheostomy Weaning Mechanical ventilation Nurse-led weaning protocol |
| title | Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial |
| title_full | Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial |
| title_fullStr | Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial |
| title_full_unstemmed | Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial |
| title_short | Comparison between a nurse-led weaning protocol and weaning based on physician’s clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial |
| title_sort | comparison between a nurse led weaning protocol and weaning based on physician s clinical judgment in tracheostomized critically ill patients a pilot randomized controlled clinical trial |
| topic | Tracheostomy Weaning Mechanical ventilation Nurse-led weaning protocol |
| url | http://link.springer.com/article/10.1186/s13613-018-0354-1 |
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