VideolaryngOscopy With Mc Grath™ vs Direct LaryngosCopy for the Positioning of A Double lumeN endOtracheal Tube (VOLCANO Study)
Phase: NA
Conditions: One Lung Ventilation, Intubation Complication
Sponsor: Luca Brazzi

VideolaryngoscOpy with McGrath™ vs direct LaryngosCopy 
for the positioning of A double lumeN endOtracheal tube 
(VOLCANO study) 
Version 1.0 27/03/2024 
 
 
 

Summary 
BACKGROUND .............................................................................................................................................. 3 
AIMS ................................................................................................................................................................. 3 
ENDPOINTS .................................................................................................................................................... 4 
Primary Endpoint .......................................................................................................................................... 4 
Secondary Endpoints ..................................................................................................................................... 4 
EXPERIMENTAL DESIGN AND RANDOMIZATION ............................................................................. 4 
Experimental Design ..................................................................................................................................... 4 
Randomization ............................................................................................................................................... 4 
Setting ............................................................................................................................................................ 4 
Protocol Amendment ..................................................................................................................................... 5 
Safety Assessment .......................................................................................................................................... 5 
STUDY POPULATION .................................................................................................................................. 5 
Inclusion Criteria .......................................................................................................................................... 5 
Exclusion Criteria ......................................................................................................................................... 5 
METHODS ....................................................................................................................................................... 5 
DATA COLLECTION..................................................................................................................................... 6 
DATA MANAGEMENT AND STATISTICAL ANALYSIS ........................................................................ 7 
Data Management ......................................................................................................................................... 7 
Statistical Analysis ......................................................................................................................................... 8 
OTHER CONSIDERATION .......................................................................................................................... 9 
Ethical consideration ..................................................................................................................................... 9 
Protocol Amendments .................................................................................................................................... 9 
Informed Consent .......................................................................................................................................... 9 
BIBLIOGRAPHY .......................................................................................................................................... 10 
 
 
 

BACKGROUND 
The placement of the double-lumen tube (DLT) can be challenging, as the endobronchial tube is larger (thus 
worsening the glottic view) and stiffer (increasing the risk of trauma and reducing maneuverability during 
placement) (1,2). An anatomically easy airway may prove more demanding when double-lumen tube 
placement is required. The success rate and intubation time can vary significantly (3,4). 
The superiority of videolaryngoscopy (VLS) over direct laryngoscopy (DL) is evident regarding the placement 
of the single-lumen orotracheal tube (SLT) (5,6). Its use is now "recommended" as the first attempt in 
anticipated difficult airways and "advised" for all routine intubations (7,8). 
19 prospective randomized controlled trials have compared the effectiveness of six VLS devices for intubating 
with DLT compared to DL in patients with anticipated easy airways (9). The main endpoints included glottic 
view, intubation time, success rate, intubation difficulty rating, incidence of malpositioning, postoperative sore 
throat, hoarseness, intubation-related complications, and intubation-related stress response. Except for superior 
glottic view with VLS compared to DL (10,11), consistent results have not emerged across different studies 
(9,10,11). This heterogeneity may be attributed to differences in operators' experience, type of VLS used, and 
definition of the primary endpoint. Conducting a randomized controlled study with adequate and larger sample 
size compared to previous ones and a homogeneous population can ascertain whether VLS can, as in the case 
of SLT, add value in DLT placement, guiding clinicians towards its routine use. 
It is necessary to clarify that current guidelines on DLT intubation do NOT recommend the "1st choice" use of 
VLS (12), a recommendation that already exists for SLT placement (7,8). For this reason, in clinical practice, 
both devices are effectively used interchangeably, based primarily on the preferences of the clinician, who also 
possesses comparable competency in both direct laryngoscopy and videolaryngoscopy. 
AIMS 
To compare the effectiveness of a single videolaryngoscope, the Mc Grath™, versus direct laryngoscopy in 
the placement of the double-lumen tube in surgery. 

ENDPOINTS  
Primary Endpoint 
First-attempt intubation success, defined as orotracheal intubation confirmed by sustained capnographic 
waveform. 
Secondary Endpoints  
Correct endobronchial positioning of the DLT, assessed by fiberoptic bronchoscopy; need for external 
laryngeal manipulation (BURP); postoperative pharyngeal pain, hoarseness, evidence of trauma; 
hemodynamic impact (defined as the need for volume resuscitation/pharmacological support of circulation or 
tachycardia and/or hypertension during and immediately after the procedure). 
EXPERIMENTAL DESIGN AND RANDOMIZATION 
Experimental Design 
Multicenter, non-profit, randomized controlled trial. The study duration is 24 months from the date of approval 
by the Ethics Committee. 
Randomization  
On the day of the intervention, eligible patients will undergo randomization. Randomization will be generated 
by a computer using a random sequence, stratified by center and based on the anticipation of a difficult airway, 
with blocks of different sizes in the random sequence. The randomization result will be made available to the 
operating room anesthesiologist. 
Setting 
• 
First Center 
Department of Anesthesia and Intensive Care 1U - Città della Salute e della Scienza (Molinette) – 
Torino - Director Prof. Luca Brazzi – P.I. Dr. Gerardo Cortese 
• 
Second Center 
Department of Anesthesia and Intensive Care, Policlinico Universitario – Campus Biomedico – Roma 
– Director Prof. Felice Eugenio Agrò – P.I. Prof. Rita Cataldo 

Protocol Amendment  
Any variation to this protocol will be reported to the local Institutional Review Board by the principal 
investigator through submission of a modification request according to local/internal regulations. 
Safety Assessment  
The study is interventional. Intubation via DL and intubation via VLS are two practices routinely used in the 
operating room, therefore no additional risks are expected for enrolled patients. 
STUDY POPULATION 
Inclusion Criteria  
All patients aged >18 years who are candidates for one-lung ventilation via double-lumen tube and do not fall 
into the explicitly stated categories of "Exclusion Criteria." 
Exclusion Criteria 
• 
Patients who refuse to consent to participation in the study. 
• 
Patients scheduled for awake intubation due to pre-operative evaluation findings of predictors of 
difficult oxygenation that contraindicate intubation under general anesthesia. 
• 
Patients with anatomical anomalies leading to tracheal and/or laryngeal displacement/compression. 
• 
Patients with contraindications to double-lumen tube placement. 
METHODS 
The patient is admitted to the operating room and positioned on the operating table. Standard monitoring used 
in thoracic surgery operating rooms is applied, including Oxygen Saturation (SaO2 %), Electrocardiogram 
(ECG), non-invasive Blood Pressure (NIBP), and neuromuscular monitoring (NMT). 
All patients are placed in a modest anti-Trendelenburg position (20°), and if obese (BMI > 30 kg/m2), they are 
positioned in the Ramped position with a wedge cushion. 
After preoxygenation with a facial mask (Target = etO2 > 90%), general anesthesia induction is performed 
with an opioid drug (Fentanyl 0.3 micrograms/kg IBW), hypnotic (Propofol 2 mg/kg IBW or Etomidate 0.2 

mg/kg IBW), and, following calibration and baseline assessment of NMT, a neuromuscular blocking agent 
(Rocuronium 1 mg/kg IBW) is administered. 
Upon reaching a Train-of-Four (TOF) value of 0 on the NMT, the procedure proceeds based on the previous 
randomization: either direct laryngoscopy with a size 3 blade or indirect videolaryngoscopy with the McGrath 
model and MAC Blade (standard, semi-McIntosh curvature). 
Subsequently, intubation with a double-lumen tube (DLT) of size determined by the operator according to the 
patient's clinical parameters is performed. The laryngoscopy or videolaryngoscopy procedure is carried out 
according to the usual practice of the operator involved in the intubation. 
The operator dedicated to the intubation procedure (consultant doctor/resident doctor) must have a minimum 
experience of >15 correct placements of double-lumen tubes performed independently with both devices 
involved in the study. 
At the end of the intubation procedure, the endobronchial tube is connected to the anesthesia machine, and 
mechanical ventilation is initiated (in Volume-Controlled Ventilation (VCV), Pressure-Controlled Ventilation 
(PCV), or Pressure-Regulated Volume Control (PRVC) mode depending on the operator's preference) with a 
tidal volume of 6-8 ml/kg IBW. 
Correct endotracheal intubation is confirmed by the detection of at least 7 valid and sustained capnographic 
waveforms. 
In case of failure of the first-choice technique, the operator proceeds with subsequent attempts using different 
devices according to a stepwise strategy: from DL to VLS MAC Blade, from VLS MAC Blade to VLS X3 
(Hyper Angulated, H-A). 
If multiple intubation attempts fail, the patient is managed according to the department's existing algorithm for 
unexpected difficult airway management. 
The data will be collected according to the attached CRF. 
DATA COLLECTION 
The following data will be recorded during the procedure (Yes/No, number, drop down menu): 

• 
Success on the first attempt (Y/N) 
• 
If the single attempt ends with tube removal from the oral cavity due to a change in strategy (Reason 
recorded: satisfactory glottic view but inability to intubate/need for reoxygenation/device change/...) 
• 
If > 1: number of attempts required (number) 
• 
Device change for intubation (transition from DL to VLS, transition from VLS MAC Blade to VLS 
X3 H-A) 
• 
Change in tube size (increase in size/decrease in size) 
• 
Operator change (Y/N) 
• 
Measurement and side of the double-lumen tube placed (measurements and side 28-41/Right-Left) 
• 
Use of bougies/introducer for intubation (Y/N) 
• 
Use of rescue techniques for reoxygenation (facial mask/laryngeal mask) 
• 
Total intubation time (Number: seconds): from insertion of the laryngoscope blade into the oral cavity 
(T0) to appearance of the capnographic waveform (T1) 
• 
Glottic view score (Number: Cormack scale) 
• 
Dosage of drugs used (Drop-down menu: drug/mg) 
• 
Hemodynamic parameters at the beginning (T0) and end of the procedure (T1): (NIBP, HR, SaO2%) 
• 
Periprocedural adverse events (desaturation < 90%, bleeding compromising glottic view, gastric 
material reflux, hypotension/hypertension/brady-tachyarrhythmias requiring fluid/pharmacological 
correction...) 
DATA MANAGEMENT AND STATISTICAL ANALYSIS 
Data Management  
The data collected for the study, obtained from the anesthesia record, will be recorded using the web application 
REDCap and stored directly in a centralized database. Data will be collected using specific time definitions: 

entry into the study (enrollment), randomization, and measurement of pre-, intra-, and post-procedural 
parameters to obtain primary and secondary endpoints. Access to the database depends on operator 
authentication and occurs through an encrypted channel. Only authorized individuals have access to data from 
their own center. 
 
Sample Size Calculation  
The literature reports a highly variable success rate in DLT placement on the first attempt with DL, estimated 
at around 64% when considering various studies. Based on this observed value, a sample size of 335 patients 
per arm allows us to achieve 80% power with a 5% alpha error rate in testing a hypothesis of a 10% absolute 
improvement over the observed value (expected value of 74%). 
The total sample size, considering potential consent withdrawals, is estimated to be 738 patients, of which 100 
will be enrolled at the Department of Anesthesia and Intensive Care 1U, Città della Salute e della Scienza di 
Torino – Molinette. As required by the updated CONSORT guidelines, a flow diagram will be developed, 
including the number of patients assessed, randomized, analyzed, and excluded. 
Statistical Analysis  
The main statistical analyses will be performed on the intent-to-treat population, which includes all randomized 
patients. 
All data collected during the protocol before randomization will be described using appropriate statistical 
summaries, such as mean and standard deviation, median and interquartile range, or frequency and proportion 
depending on the distribution of the variable. Statistics will be presented stratified by treatment arm. 
The primary endpoint of intubation success on the first attempt will be compared between the two arms using 
the chi-square test (or Fisher's test if necessary). Both relative effects measured with risk ratio and their 95% 
confidence intervals will be evaluated. 
Secondary quantitative endpoints (time and scoring) will be compared between the two arms using independent 
samples t-tests or the Wilcoxon test depending on the distribution type. 

A Data Safety Monitoring Board will be established for interim evaluation of the adequacy of the calculated 
sample size. 
OTHER CONSIDERATION 
Ethical consideration 
The study will be conducted following the principles of the Declaration of Helsinki and national regulations 
regarding the conduct of clinical trials. Clinical experimentation will be carried out in accordance with Good 
Clinical Practice standards (D.M. 27 April 1992) and subsequent amendments (D.M. 15 July 1997 and D.L. 
211/2003). The study must be approved by each center, following approval from the coordinating center (Città 
della Salute e della Scienza di Torino - Molinette). 
Protocol Amendments  
Any modifications to the protocol will be made in the form of amendments. No changes to the protocol are 
permitted during the study period. 
Informed Consent  
All patients will be informed about the study procedure on the day of the preoperative anesthesiological 
assessment. Each patient must sign the written informed consent, as approved by the Local Ethics Committee. 
 
 

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