臨床研究等提出・公開システム

Date of registration	Jan. 30, 2026
Last modified on	Jan. 30, 2026
Trial ID	jRCT1042250175

Scientific Title	Effect of Headrest Height on Double-Lumen Tube Intubation Using the McGRATH Video Laryngoscope: A Randomized Controlled Trial (Headrest-McGRATH RCT)
Public Title	Impact of Headrest Height on Double-Lumen Tube Intubation with the McGRATH Video Laryngoscope: Randomized Trial (Headrest-McGRATH Trial)

Contact for Scientific Queries	Name	Masahito Nakatani
	Affiliation	Seirei Mikatahara General Hospital
	Address	Seirei Mikatahara Hospital 3453 Mikatahara-cho, Chuo Ward, Hamamatsu City, Shizuoka Prefecture
	Telephone	+81-53-436-1251
	E-mail	nakatani.masahito@gmail.com
Contact for Public Queries	Name	Nakatani Masahito
	Affiliation	Seirei Mikatahara General Hospital
	Address	Seirei Mikatahara Hospital 3453 Mikatahara-cho, Chuo Ward, Hamamatsu City, Shizuoka Prefecture
	Telephone	+81-53-436-1251
	E-mail	nakatani.masahito@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 30, 2026
Target sample size		81
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	uncontrolled control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	From the date of implementation approval by the hospital director through March 2028, patients scheduled for surgical treatment during routine care at this hospital who meet the following criteria: 1. Adult patients undergoing general anaesthesia requiring airway management with a double lumen tube (DLT) and one-lung ventilation. 2. Individuals for whom informed consent has been obtained through their signature on the consent form for participation in this study.
	Exclusion Criteria	Refusal to participate in the study Outpatient surgery Existing neurological or cognitive impairment Use of antipsychotic medications Patients with anatomical abnormalities of the airway BMI (body mass index) exceeding 35 kg/m2or body weight of 100 kg or more Mouth opening less than 2.5 cm Acute sore throat Conditions with risk of aspiration ( pregnancy, gastroesophageal reflux disease, hiatal hernia) History of difficult intubation Limited neck mobility (atlantoaxial subluxation, history of cervical spine or head/neck surgery) Patients deemed difficult for bronchoscopy use
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Thoracic Surgery
Intervention(s)		Adjust the pillow height when inserting a double-lumen tracheal tube (DLT).
Primary Outcome(s)		Time from insertion of the McGRATH video laryngoscope to passage of the DLT white cuff through the glottis
Secondary Outcome(s)		Time from insertion of the McGRATH video laryngoscope to placement in the left main bronchus Time from insertion of the McGRATH video laryngoscope to observation of a capnogram on the CO2 monitor First attempt DLT intubation success rate Success rate within two attempts Time required for success within two attempts Cormack Lehane classification (classifies the field of view obtained by direct laryngeal visualization based on observed structures) POGO score (a score evaluating the percentage of vocal cords visible during tracheal intubation) Need for positional correction via bronchoscopy Presence of additional maneuvers required for guidance into the left main bronchus Occurrence of hypoxemia (SpO2 < 90%) Postoperative procedure-related complications (sore throat, hoarseness) Clinical findings (age, gender, height, weight, BMI, medications, medical history, comorbidities) Laboratory findings (preoperative liver/kidney function, coagulation tests) Treatment (surgical procedure, administered drugs, analgesics, sedatives)

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Seirei Mikatahara Hospital Ethics Committee
Address	3453 Mikatahara-cho, Chuo Ward, Hamamatsu City, Shizuoka Prefecture, Shizuoka
Telephone	+81-534361251
E-Mail	nakatani.masahito@gmail.com
Approval Status	Approval
Date of approval	Jan. 19, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none