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

NCT04471467 — Unknown, 34 participants, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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Registry	NCT04471467
Status	Unknown
Study type	Observational
Enrollment	34 (Estimated)
Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Conditions	Nasotracheal Intubation
Interventions	Fixed tracheal tube (Procedure)
Dates	start 2020-07-20 (estimated), primary completion 2020-11-20 (estimated), completion 2020-12-20 (estimated), first posted 2020-07-15, last updated 2020-07-21

-Summary

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
group F		Procedure: Fixed tracheal tube	Using tracheal tube fixation method （According to the needs of the surgery, the surgeon who did not participate in the trial）
group N			No tracheal tube fixation （According to the needs of the surgery, the surgeon who did not participate in the trial）

Fixed tracheal tube (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.

+Outcome measures

Primary outcomes

pressure between the nasal tube and nose [Immediately after procedure]: pressure between the nasal tube and nose under different conditions

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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