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
Protocol serial number	N/A
Sponsor	Inselspital, University Hospital Berne (Switzerland)
Funder	University of Berne (Switzerland) - Scientific fund of the Department of Anaesthesia and Pain Therapy and scientific fund of the Swiss Society of Anesthesiologists (SGAR)

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 of protocol

Not provided at time of registration

Contact information

Dr Marius Wipfli
Scientific

University Hospital Bern
Freiburgstrasse
Bern
3010
Switzerland

Study information

Primary study design	Observational
Study design	Prospective observational study, non-randomised, non-controlled
Secondary study design	Cohort study
Study type	Participant 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 objectives	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)
Health condition(s) or problem(s) studied	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(s)	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).
Key secondary outcome measure(s)	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
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Total final enrolment	182
Key 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).
Key exclusion criteria	1. Refusal of post-intervention written informed consent 2. Aged less than 18 years
Date of first enrolment	01/06/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Bern

Bern
3010
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/04/2019: Publication reference and total final enrolment number added.