To determine if adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery prevents postoperative dysphagia. Furthermore laryngo-tracheal complaints (hoarseness and sore throat) will be scored.
ID
Source
Brief title
Condition
- Administration site reactions
- Procedural related injuries and complications NEC
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative dysphagia
Secondary outcome
Postoperative sore throat and hoarseness.
Background summary
In anterior cervical spine surgery a retractor is used. Previous studies showed
an increase of endotracheal tube cuff pressures after placement of a retractor.
It is known that a high endotracheal tube cuff pressure increases the incidence
of postoperative dysphagia, hoarseness, and sore throat. However, until now no
evidence supports maintaining the endotracheal tube cuff pressure during
anterior cervical spine surgery to prevent this comorbidity.
Study objective
To determine if adjusting endotracheal tube cuff pressure after placement of a
retractor during anterior cervical spine surgery prevents postoperative
dysphagia. Furthermore laryngo-tracheal complaints (hoarseness and sore throat)
will be scored.
Study design
Study patients are randomized in two arms. In the control arm endotracheal tube
cuff pressure is not adjusted after retractor placement. In the intervention
arm endotracheal tube cuff pressure after retractor placement is maintained at
20 mm Hg. Twenty-four hours and 2 months after the operation the study patients
are questioned about dysphagia, hoarseness and sore throat.
Intervention
Maintaining the endotracheal tube cuff pressure to 20 mm Hg after retractor
placement
Study burden and risks
The study patient will be interviewed postoperative. Maintaining the
endotracheal tube cuff pressure does not imply extra risks of burden to the
study patient .
Lijnbaan 32
2501 CK 2501CK
NL
Lijnbaan 32
2501 CK 2501CK
NL
Listed location countries
Age
Inclusion criteria
Male and non-pregnant female patients between 18-90 years of age requiring anterior cervical spine surgery on 1 or more levels with the use of a retractor
Exclusion criteria
Pre-operative dysphagia, hoarseness, sore throat or recurrent laryngeal nerve palsy
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL35829.098.11 |
| OMON | NL-OMON25072 |