Skip to content

Fibreoptic Intubation With and Without Sellick´s Maneuver

View af Larynx and Intubation With a Flexible Fibreoptic Scope With and Without Sellick´s Maneuver.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01357824
Enrollment
50
Registered
2011-05-23
Start date
2011-06-30
Completion date
2011-11-30
Last updated
2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Intraesophageal, Respiratory Aspiration of Gastric Contents

Keywords

Intubation, Sellick´s maneuver, aspiration, [E05.497.578]

Brief summary

The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on the throat, just below the Adams apple, to occlude the esophagus, in order to prevent aspiration of gastric contents, on intubation with a flexible fiberscope. The result of this study will be participate in the discussion of the importance of Sellick´s Maneuver.

Detailed description

The patients included in this study has volunteered after sufficient information, and must be ASA-class I-II, 18 years or more, and must not have indications for a rapid sequence induction. The patient will be intubated twice, with and without Sellick´s maneuver. It is blinded to the intubating physician, in which order this pressure is applied. The outcomes measures will be time of intubation, oxygen saturation before and after intubation and a Cormack Scale graduation of the visibility of the vocal cords. The intubation will be failed, if it cannot be performed under 120 seconds, or if the patients desaturate to 95% or less.

Interventions

PROCEDUREApplication of Sellick´s maneuver.

The patient will be intubated with a flexible fiberscope, Olympus model, under the application of Sellick´s maneuver, with the recommended 30 Newtons pressure, and also, as control, be intubated with a sham Sellick´s maneuver, with 0 Newton. The order of the pressures is randomized, and it is blinded to the intubating physician by a cloth which of the maneuvers that is used. The pressure is measured be a pediatric cuff, which is pressed against the throat.

Sponsors

Glostrup University Hospital, Copenhagen
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* ASA I-II * Informed consent to participate in the study * Age 18 or older * Predicted difficult airways

Exclusion criteria

* Body mass index more then 35 * Patients with an indication for a rapid sequence induction (reflux, Hiatus herniation, Gastric bypass)

Design outcomes

Primary

MeasureTime frameDescription
Time of intubation180 secondsThe investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver

Secondary

MeasureTime frameDescription
Number of patients that cannot be intubated after 120 sec. with and without Sellick´s maneuver180 secondsPatients that is not intubated after 120 seconds in each trial, will count as not intubated after 120 seconds.
Fall of oxygen saturation after intubation with and without Sellick´s maneuver.180 secondsThe investigators measure the oxygen saturation on a finger device at the beginning and the and of the intubations.
Visualization of the vocal cords180 secondsThe investigators will observe the visualization of the vocal cords, and provide the result on the Cormack Score.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026