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

NCT ID: NCT04471467

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2020-12-20

Brief 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.

Detailed 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.

Conditions

Nasotracheal Intubation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

group F

Using tracheal tube fixation method （According to the needs of the surgery, the surgeon who did not participate in the trial）

Fixed tracheal tube

Intervention Type: PROCEDURE

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.

group N

No tracheal tube fixation （According to the needs of the surgery, the surgeon who did not participate in the trial）

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Yu Sun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yu Sun, MD,PhD

Role: CONTACT

dr_sunyu@163.com

0086-136-1189-5542

Wenyue Hu, MM

Role: CONTACT

huwenyue08@163.com

0086-180-1918-0376

Other Identifiers

PUs

Identifier Type: -

Identifier Source: org_study_id