Efficacy of tracheal and gastric tube contemporary insertion under videolaryngoscopy in anesthetized patients: randomized controlled trial

JRCT ID: jRCT1032240078

Registered date:13/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients requiring insertion of a gastric tube in general anesthesia for scheduled surgery.
• Date of first enrollment: 13/05/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

In the case of the "tracheal and gastric tube contemporary insertion" group, after tracheal intubation is performed using the videolaryngoscope, a slit gastric tube insertion guide is inserted into the esophagus without removing the videolaryngoscope and without changing the field of view. After the slit gastric tube insertion guide is fully inserted, the tracheal tube is connected to the respiratory circuit and mechanical ventilation is started.
In the case of the "blind slit gastric tube insertion guide" method, after intubation with the videolaryngoscope, the videolaryngoscope is removed, the endotracheal tube is connected to the respiratory circuit, and mechanical ventilation is started. After fixing the tracheal tube with a sticky tape, a slit gastric tube insertion guide is inserted into the esophagus through the gastric tube blindly.

Outcome(s)

• Primary Outcome: Frequency and types of complications during gastric tube insertion.

Secondary Outcome

First-time success rate for oral gastric tube insertion.
Time taken from tracheal intubation to oral gastric tube insertion.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who are 20 years of age or older at the time of consent.
2) Patients scheduled to undergo surgery requiring tracheal intubation under general anesthesia.
3) Patients who require oral gastric tube insertion during surgery.
4) Patients whose preoperative physical status (ASA Physical Status Classification System) is class I or II.
5) Patients whose preoperative physical status (ASA Physical Status Classification System) is class I or II.
Class I: No organic, physiological, biochemical, or psychological abnormalities. The disease to be operated on is localized and does not cause systemic (systematic) disability.
Class II: Mild to moderate systematic disorders. The cause is a disease that has been the subject of surgical treatment or is due to other pathophysiological causes.
5) Patients who can provide written consent for participation in this study.

Exclude criteria

1) Patients with esophageal varices.
2) Patients with head and neck trauma.
3) Patients with expected esophageal obstruction.
4) Patients with untreated coagulopathy.
5) Patients after surgery or radiotherapy in the head and neck region or upper gastrointestinal tract.
6) Patients with infectious diseases that are at risk of infection.
7) Other patients who are deemed inappropriate by the physician.

Related Information

• Primary Sponsor: Yasuhisa Okuda
• Secondary Sponsor: Okuda Yasuhisa