Effect of Tracheal Tube Fixation Method on Nasal Pressure of Patients With Nasal Tracheal Intubation

Nasotracheal Intubation Clinical Trial

Official title:

Effect of Tracheal Tube Fixation Method on Nasal Pressure of Patients With Nasal Tracheal Intubation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04471467
• Other study ID #: PUs
• Status: Not yet recruiting
• Start date: July 20, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: July 2020
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Yu Sun, MD,PhD
• Phone: 0086-136-1189-5542
• Email: dr_sunyu[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck .Various complications can occur such as epistaxis, bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have failed to attract clinical attention.The investigators have observed that the surgeon fixed the nasal tracheal tube and threaded tube directly to the patient's head. The investigators suspect that this method can reduce the pressure between the nasal tube and the nose.

Description:

Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck .Various complications can occur such as epistaxis, bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have failed to attract clinical attention.Oral and maxillofacial surgery usually uses nasal endotracheal intubation to manage the airway. The tube fixation directly presses the skin of the patient's nose. Due to the operation, the surgeon must stand on the head of the patient and there is not enough space to place the tracheal tube bracket. Prolonged vascular compression on the nasal region may be caused by excessive tension and angulation of the nasotracheal tube against the nasal tissue.Studies have proposed the use of nasal packing, hydrocolloidal dressing and modified nasal tracheal tube to reduce the direct contact between the nasal tube and the nose, relieve the pressure between the two, so as to prevent the occurrence of alar pressure ulcers, but there is no objective data to show the degree of pressure reduction.In clinical practice, the investigatorshave observed surgeons fixed the nasal endotracheal tube and threaded the tube directly to the patient's head. The investigators suspect that this method can reduce the pressure between the nasal tube and the nose, so the investigators want to use a pressure sensor to monitor the pressure between the two.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: December 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age between 18-60 years old

• ASA physical status I and II

• Requiring general anesthesia with nasal intubation

Exclusion Criteria:

• Previous history of pressure ulcers

• Nasal trauma or defect

• The need for emergency surgery

• Contraindications to nasal intubation

• Pregnancy

Related Conditions & MeSH terms

• Nasotracheal Intubation

Intervention

Procedure:
• Fixed tracheal tube
Tracheal tube fixation is determined by the surgeon according to the needs of the operation and is an independent process. Our research simply installed a monitoring device between the tube and the nose. The tube fixation takes place whether the observation of pressures is agreed to or not, as per standard protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pressure between the nasal tube and nose	pressure between the nasal tube and nose under different conditions	Immediately after procedure