Flexible nasopharyngoscopy to assess the dislocation rate of airway exchange catheters in the post-operative-care-unit (PACU)
| ISRCTN | ISRCTN96726807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96726807 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/05/2010
- Registration date
- 10/06/2010
- Last edited
- 12/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Marius Wipfli
Scientific
Scientific
University Hospital Bern
Freiburgstrasse
Bern
3010
Switzerland
Study information
| Study design | Prospective observational study, non-randomised, non-controlled |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Flexible nasopharyngoscopy to assess the dislocation rate of airway exchange catheters in the post-operative-care-unit (PACU): a prospective observational study |
| Study hypothesis | After insertion of an airway exchange catheter through an endo-tracheal tube and extubation of that tube over the airway exchange catheter in the operating room (OR), the incorrect placement (dislocation rate) of an orally placed airway exchange catheter is significantly higher than of a nasally placed airway exchange catheter from the time of admission in the post-operative-care-unit (PACU) until remove of the airway exchange catheter. The difference in disloction rates is at least 10%. Null hypothesis: There is no significant difference between oral and nasal airway exchange catheter regarding correct endo-tracheal placement after extubation until removal. |
| Ethics approval(s) | Local ethics committee (Kantonale Ethikkommission KEK) approved on the 20th April 2010 (ref: 060/10) |
| Condition | Anaesthesia |
| Intervention | After extubation in the OR on admission to the PACU we will assess the position of the CAEC with a small flexible pharyngoscope of a diameter of only 2.8 mm (EF-BNI, Acutronic Medical Systems AG, Switzerland). We will assess the position in both groups (oral and nasal) and at three different times: On admission of the patient to the PACU, at removal of the CAEC (in most cases at the end of the PACU-stay) and at any change of ETCO2 waveform indicating no gas flow. This painless examination is a standard investigation during an ENT exploration at the ENT Department of the University Hospital and may be done without further sedation or analgesics. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Dislocation rates of nasally placed airway exchange catheters versus dislocation rates of orally placed airway exchange catheters. Definition of dislocation is visualised extra-tracheal position (oesophageal, pharyngeal, enoral) of the CAEC (flexible nasopharyngosopy). |
| Secondary outcome measures | 1. Demographic and morphometric data of the patients 2. Type of surgery 3. Duration of surgery and anesthesia 4. Blood loss during surgery 5. Indication for the airway exchange catheter 6. Duration of use of airway exchange catheter in minutes (mean, SD) 7. Number of events of ETCO2 measurement (indicating no gas flow) 8. Position of the CAEC at the time of an event of ETCO2 assessed by flexible nasopharyngoscopy 9. Sensitivity and specificity of ETCO2 measurement over CAEC 10. Patients tolerance against airway exchange catheter orally versus nasally (category 1, tolerated with any problem ¨C 10 not tolerated at all, therefore CAEC removed) 11. Indication for the removal of the airway exchange catheter 12. Duration of use of airway exchange catheter in minutes (mean, SD) 13. Re-intubation rate and time after extubation in minutes |
| Overall study start date | 01/06/2010 |
| Overall study end date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 182 |
| Participant inclusion criteria | All patients (aged greater than 18 years, either sex) entering the PACU with an oral or nasal airway exchange catheter will be included in the observational study. After they regained full consciousness, they will be asked whether the obtained data may be used for publication (informed consent). |
| Participant exclusion criteria | 1. Refusal of post-intervention written informed consent 2. Aged less than 18 years |
| Recruitment start date | 01/06/2010 |
| Recruitment end date | 31/12/2011 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital Bern
Bern
3010
Switzerland
3010
Switzerland
Sponsor information
Inselspital, University Hospital Berne (Switzerland)
University/education
University/education
Scientific fund of the Department of Anesthesia and Pain Therapy
Freiburgstrasse
Bern
3010
Switzerland
| Website | http://www.insel.ch/ |
|---|---|
"ROR" |
https://ror.org/01q9sj412 |
Funders
Funder type
University/education
University of Berne (Switzerland) - Scientific fund of the Department of Anaesthesia and Pain Therapy and scientific fund of the Swiss Society of Anesthesiologists (SGAR)
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 | 11/04/2019 | 12/04/2019 | Yes | No |
Editorial Notes
12/04/2019: Publication reference and total final enrolment number added.
