Effect of an analgo-sedation protocol for neurointensive patients: a two-phase pilot study
| ISRCTN | ISRCTN80999859 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80999859 |
| Secondary identifying numbers | 2093 |
- Submission date
- 24/10/2009
- Registration date
- 05/11/2009
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ingrid Egerod
Scientific
Scientific
The University Hospitals Center for Nursing and Care Research (UCSF)
Rigshospitalet Dept. 7331
Blegdamsvej 9
Copenhagen
DK-2100
Denmark
| Phone | +45 3545 7365 |
|---|---|
| ie@ucsf.dk |
Study information
| Study design | Interventional non-randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | Effect of an analgo-sedation protocol for neurointensive patients: a two-phase interventional non-randomised pilot study |
| Study objectives | It was hypothesised that the sedation protocol would promote a shift from sedation-based to analgesia-based sedation, and show signs of improved pain management. |
| Ethics approval(s) | 1. Danish Data Protection Agency, approved on 21/12/2006 (J.nr.2006-41-7419) 2. Danish National Committee on Biomedical Research Ethics, approved on 06/12/2006 (J.nr.KF01-2006-4507) |
| Health condition(s) or problem(s) studied | Sedation and pain management in mechanically ventilated neurointensive care patients |
| Intervention | 100 participants were recruited while the previous sedation practice was in effect, and new 100 participants were recruited after the introduction of the new sedation protocol (200 participants recruited in total). The new protocol included the following: 1. Pain medication should be given before a sedative 2. A sedative should be used only if necessary 3. Remifentanil should be used for short-term sedation 4. Fentanyl should be used for traumatic brain injury |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Remifentanil, Fentanyl |
| Primary outcome measure | 1. A shift from sedation-based to analgesia-based sedation (analgo-sedation), assessed from the chages in the use of sedatives and analgesic agents in each patient 2. Improved pain management, assessed daily in each patient using the Pain Intensity (PI) scale For all primary and secondary outcome measures, the participants were followed-up until they were off mechanical ventilation and sedation. |
| Secondary outcome measures | 1. Incidence of late pneumonia. Late pneumonia was defined as pneumonia acquired >48 hours after intubation. 2. Accidental extubations 3. Duration of sedation For all primary and secondary outcome measures, the participants were followed-up until they were off mechanical ventilation and sedation. |
| Overall study start date | 01/01/2007 |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 215 |
| Key inclusion criteria | 1. Both males and females, >17 years old 2. Admitted to the neurointensive care unit (NICU) 3. Tracheally intubated within 24 hours 4. Mechanically ventilated 5. Receiving continuous infusions of sedatives and analgesics |
| Key exclusion criteria | 1. Potential organ donors 2. Non-sedated and non-intubated patients 3. Patients transferred intubated from other units |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- Denmark
Study participating centre
The University Hospitals Center for Nursing and Care Research (UCSF)
Copenhagen
DK-2100
Denmark
DK-2100
Denmark
Sponsor information
Copenhagen University Hospital (Denmark)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Karen-Lise Welling
Neurointensive Unit 2093
Department of Neuroanaesthesiology
The Neuroscience Centre
Rigshospitalet
Copenhagen
DK-2100
Denmark
| Website | http://www.rigshospitalet.dk |
|---|---|
"ROR" |
https://ror.org/05bpbnx46 |
Funders
Funder type
Hospital/treatment centre
Copenhagen University Hospital Rigshospitalet (Denmark)
No information available
The University Hospitals Centre for Nursing and Care Research (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
