## Protocol Section
### Identification Module
**NCT ID:** NCT03568279

**Brief Title:** Jaw-thrust on Postoperative Sore Throat

**Official Title:** Influence of Two-handed Jaw Thrust on Postoperative Sore Throat

#### Organization Study ID Info
**ID:** JTPOST
#### Organization
**Class:** OTHER
**Full Name:** Keimyung University Dongsan Medical Center
### Status Module
#### Completion Date
**Date:** 2019-08-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2018-09-28

**Type:** ACTUAL

**Last Update Submit Date:** 2018-09-27

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-07-01

**Type:** ACTUAL

**Status Verified Date:** 2018-09

#### Study First Post Date
**Date:** 2018-06-26
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-04
**Study First Submit QC Date:** 2018-06-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Keimyung University Dongsan Medical Center

#### Responsible Party

**Investigator Affiliation:** Keimyung University Dongsan Medical Center

**Investigator Full Name:** Hyun-Chang Kim

**Investigator Title:** Assistant professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing endotracheal intubation for general anesthesia.

### Conditions Module

**Conditions:**

- General Anesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 96

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The attending anesthesiologist provided intubation without two-handed jaw thrust.

**Intervention Names:**

- Procedure: Control

**Label:** Control

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The attending anesthesiologist provided intubation with two-handed jaw thrust.

**Intervention Names:**

- Procedure: Two-handed jaw thrust

**Label:** Two-hand

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Two-hand

**Description:** The assistant applied two-handed jaw thrust for intubation.

**Name:** Two-handed jaw thrust

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** The intubation was done without two-handed jaw thrust.

**Name:** Control

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of participants with postoperative sore throat for postoperative 24 hour

**Time Frame:** At postoperative 24 hour

#### Secondary Outcomes

**Measure:** Number of participants with postoperative sore throat

**Time Frame:** At postoperative 2, 4, and 24 hour

**Description:** Visual analogue scales will be used (10: most imaginable pain, 0: no pain).

**Measure:** Postoperative sore throat scores

**Time Frame:** At postoperative 2, 4, and 24 hour

**Measure:** Number of participants with postoperative hoarseness

**Time Frame:** At postoperative 2, 4, and 24 hour

**Measure:** Number of participants with postoperative shivering

**Time Frame:** At postoperative 2, 4, and 24 hour

**Description:** Visual analogue scales will be used (10: most imaginable pain, 0: no pain).

**Measure:** Wound pain scores

**Time Frame:** At postoperative 2, 4, and 24 hour

**Measure:** Number of participants with jaw discomfort

**Time Frame:** At postoperative 2, 4, and 24 hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Mallampatti scores greater than 2
* Recent sore throat
* Cervical spine disease
* Recent upper respiratory infection
* Recent analgesics
* History of head and neck surgery
* Friable teeth
* Multiple intubation attempts

**Maximum Age:** 80 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Daegu

**Country:** Korea, Republic of

**Facility:** Hyun-Chang Kim

**State:** Non-US/Canada

**Zip:** 137-040

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Huh H, Go DY, Cho JE, Park J, Lee J, Kim HC. Influence of two-handed jaw thrust during tracheal intubation on postoperative sore throat: a prospective randomised study. J Int Med Res. 2021 Feb;49(2):300060520961237. doi: 10.1177/0300060520961237.

**PMID:** 33535830

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000010608

- Term: Pharyngeal Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M13519

- Name: Pharyngitis

- Relevance: HIGH

- As Found: Sore Throat

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13515

- Name: Pharyngeal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010612

- Term: Pharyngitis

### Misc Info Module

- Version Holder: 2024-05-24
