## Protocol Section
### Identification Module
**NCT ID:** NCT01635179

**Brief Title:** Laryngeal View With Videolaryngoscopy

**Official Title:** Laryngeal View With Intubation by Videolaryngoscopy With and Without Sellicks Maneuver.

#### Organization Study ID Info
**ID:** Glo-anaest-2012
#### Organization
**Class:** OTHER
**Full Name:** Glostrup University Hospital, Copenhagen
### Status Module
#### Completion Date
**Date:** 2012-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-04-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-04-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Start Date
**Date:** 2012-04

**Status Verified Date:** 2013-04

#### Study First Post Date
**Date:** 2012-07-09
**Type:** ESTIMATED
**Study First Submit Date:** 2012-06-19
**Study First Submit QC Date:** 2012-07-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Glostrup University Hospital, Copenhagen

#### Responsible Party

**Investigator Affiliation:** Glostrup University Hospital, Copenhagen

**Investigator Full Name:** Bjorn Arenkiel

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** To prevent bronchial aspiration during induction of anaesthesia it has been a common procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and thereby prevent aspiration. During the last ten years the efficiency of this maneuver has been discussed, since it probably prolong the intubation time and do not significantly reduces the risk of aspiration.

The hypothesis is that Sellicks Maneuver prolong the time of intubation and reduces the view of the laryngeal inlet, during intubation with a videolaryngoscopy.

The hypothesis is tested by a double-blinded randomized study where patients is intubated twice, with and without Sellicks Maneuver, in a randomized order. The specific cricoid pressure is blinded to the personal performing the intubation.

### Conditions Module

**Conditions:**

- Respiratory Aspiration

- Hypoxemia

**Keywords:**

- Videolaryngoscopy

- Bronchial Aspiration

- Hypoxia

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A cricoid pressure of 30 N is done to occlude esophagus under a rapid sequence induction.

**Intervention Names:**

- Procedure: Cricoid pressure

**Label:** Cricoid pressure

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cricoid pressure

**Description:** The patient is intubated twice, once with a cricoid pressure and once with a sham-pressure, when performing a videolaryngoscopy.

**Name:** Cricoid pressure

**Other Names:**

- Sellicks maneuver.

- Profylaxis of bronchial aspiration

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The primary outcome measure is the rate of completed and failed intubations. A intubations is failed when the oxygen saturation is less then 95% or the intubation time is longer then 120 seconds.

**Measure:** Completed intubation within 120 seconds

**Time Frame:** 120 seconds

#### Secondary Outcomes

**Description:** The secondary outcome measure is a description of the laryngeal inlet according the the Cormack-Lehan system, and how Sellicks Maneuver alters that view.

**Measure:** A description of the laryngeal inlet

**Time Frame:** 120 seconds

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA 1-2, BMI \< 35,
* no indication for rapid sequence induction,
* age \> 18,
* able to give consent.

Exclusion Criteria:

* ASA \> 2,
* BMI \> 35,
* RSI

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Glostrup

**Country:** Denmark

**Facility:** Glostrup University Hospital

**Zip:** 2600

#### Overall Officials

**Official 1:**

**Affiliation:** GlustrupUH dept of Anaesthesia

**Name:** Bjørn Arenkiel, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: HIGH

- As Found: Respiratory Aspiration

- ID: M4185

- Name: Hypoxia

- Relevance: HIGH

- As Found: Hypoxemia

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000053120

- Term: Respiratory Aspiration

- ID: D000000860

- Term: Hypoxia

### Misc Info Module

- Version Holder: 2024-05-24
