## Protocol Section
### Identification Module
**NCT ID:** NCT01888679

**Brief Title:** Influence of Head Positioning on the Movement of the Endotracheal Tube

**Official Title:** Influence of Head Positioning on the Movement of the Endotracheal Tube

#### Organization Study ID Info
**ID:** 229/12
#### Organization
**Class:** OTHER
**Full Name:** University of Lausanne Hospitals
### Status Module
#### Completion Date
**Date:** 2013-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-02

**Type:** ACTUAL

**Last Update Submit Date:** 2020-02-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-03

**Type:** ACTUAL

#### Start Date
**Date:** 2012-08

**Status Verified Date:** 2020-02

#### Study First Post Date
**Date:** 2013-06-28
**Type:** ESTIMATED
**Study First Submit Date:** 2013-06-21
**Study First Submit QC Date:** 2013-06-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Lausanne Hospitals

#### Responsible Party

**Investigator Affiliation:** University of Lausanne Hospitals

**Investigator Full Name:** Patrick Schoettker,MD PD

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate and measure the movement of the endotracheal tube depending on the type and the amount of movement of the head of the patient intubated using a flexible fiberoptic.

**Detailed Description:** We performed a maximal head-neck movement trial on 50 adult patients, American Society of Anaesthesiologists 1 or 2. Patients with body mass index N35 kg · m-2, height b150 cm, airway malformations, pulmonary diseases, difficulties in neck flexion or extension, previous ENT surgery or radiotherapy, gastroesophageal reflux, or dental instability were excluded from the study.

We measured the change in distance between the ETT tip and the carina, using a fiberscope through the ETT.

### Conditions Module

**Conditions:**

- Other Conditions That May Be A Focus of Clinical Attention

**Keywords:**

- Airway

- Endotracheal intubation

- selective intubation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** head movement in extension, flexion, right and left rotation

**Intervention Names:**

- Procedure: Head movement

**Label:** head movement

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- head movement

**Description:** Head movement in extension, flexion, right and left rotation

**Name:** Head movement

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Tube movement related to movement of the head

**Measure:** Displacement of the endotracheal tube.

**Time Frame:** 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients older than 16 years
* ASA 1-2
* Elective surgery

Exclusion Criteria:

* Pathological changes of the trachea.
* Less than BMI 35 kg/m2.
* Patients with rheumatoid arthritis or other limitation to cervical mobility.
* Emergency surgery.
* Individuals measuring less than 150 cm.

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lausanne

**Country:** Switzerland

**Facility:** University of Lausanne Hospitals

**State:** Vaud

**Zip:** 1011

#### Overall Officials

**Official 1:**

**Affiliation:** University of Lausanne Hospitals

**Name:** Patrick Schoettker, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Tailleur R, Bathory I, Dolci M, Frascarolo P, Kern C, Schoettker P. Endotracheal tube displacement during head and neck movements. Observational clinical trial. J Clin Anesth. 2016 Aug;32:54-8. doi: 10.1016/j.jclinane.2015.12.043. Epub 2016 Mar 22.

**PMID:** 27290945

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
