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

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.

Study Overview

• Status: Unknown
• Conditions: Nasotracheal Intubation
• Intervention / Treatment: Procedure: Fixed tracheal tube

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.

• Study Type: Observational
• Enrollment (Anticipated): 34

Contacts and Locations

• Study Contact: Name: Yu Sun, MD,PhD; Phone Number: 0086-136-1189-5542; Email: dr_sunyu@163.com
• Study Contact Backup: Name: Wenyue Hu, MM; Phone Number: 0086-180-1918-0376; Email: huwenyue08@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who will be receiving general anesthesia with nasal intubation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group F; Using tracheal tube fixation method （According to the needs of the surgery, the surgeon who did not participate in the trial）	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.
group N; No tracheal tube fixation （According to the needs of the surgery, the surgeon who did not participate in the trial）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pressure between the nasal tube and nose	pressure between the nasal tube and nose under different conditions	Immediately after procedure

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 20, 2020
• Primary Completion (Anticipated): November 20, 2020
• Study Completion (Anticipated): December 20, 2020

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 18, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pressure Injury; nasotracheal intubation
• Other Study ID Numbers: PUs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No