Condition category
Surgery
Date applied
07/05/2010
Date assigned
10/06/2010
Last edited
10/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marius Wipfli

ORCID ID

Contact details

University Hospital Bern
Freiburgstrasse
Bern
3010
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Flexible nasopharyngoscopy to assess the dislocation rate of airway exchange catheters in the post-operative-care-unit (PACU): a prospective observational study

Acronym

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

Local ethics committee (Kantonale Ethikkommission KEK) approved on the 20th April 2010 (ref: 060/10)

Study design

Prospective observational study, non-randomised, non-controlled

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

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

Trial participating centre

University Hospital Bern
Bern
3010
Switzerland

Sponsor information

Organisation

Inselspital, University Hospital Berne (Switzerland)

Sponsor details

Scientific fund of the Department of Anesthesia and Pain Therapy
Freiburgstrasse
Bern
3010
Switzerland

Sponsor type

University/education

Website

http://www.insel.ch/

Funders

Funder type

University/education

Funder name

University of Berne (Switzerland) - Scientific fund of the Department of Anaesthesia and Pain Therapy and scientific fund of the Swiss Society of Anesthesiologists (SGAR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes