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Clinical comparison of two submental intubation methods (Altmeyer and Seldinger) in patients candidates for fixation of maxillofacial injuries

Protocol summary

Study aim
Clinical comparison of two submental intubation methods (Altmeyer and Seldinger) in patients candidates for fixation of maxillofacial injuries
Design
This clinical trial study was a parallel-group, single-blind, randomized study on 22 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This clinical trial study will be conducted on 22 patients who are candidates for fixation of maxillofacial injuries referred to Shahid Rahmanun Hospital in 2025. The outcome assessors, caregivers, and data analysts will not be aware of the grouping of the samples and the type of surgery performed.
Participants/Inclusion and exclusion criteria
Patients who were candidates for fixation of maxillofacial injuries and submental intubation under general anesthesia were included in the study. Patients with traumatic brain injury, coagulopathy, psychiatric diseases, polytrauma and requiring long-term respiratory support will be excluded from the study.
Intervention groups
Intervention group 1: an incision is made in the paramedian area under the jaw. Using arterial forceps, a blunt tunnel is created towards the floor of the mouth and after suction, the endotracheal tube (ETT) cuff is evacuated and removed from the tunnel. Then the ETT is separated from the circuit, passed through the tunnel with the help of forceps and connected in the new location. Intervention group 2: In this method, a tracheostomy kit is used. The needle with the sheath is inserted into the submental area and after appearing in the mouth, the guide wire is inserted and the path is widened. After creating the path, a similar process is performed as in the first group, including evacuation and passage of the cuff and ETT through the submental tunnel and finally, the tube is connected to the respiratory circuit.
Main outcome variables
Bleeding, duration of intubation, skin scar

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250419065388N1
Registration date: 2025-05-08, 1404/02/18
Registration timing: prospective

Last update: 2025-05-08, 1404/02/18
Update count: 0
Registration date
2025-05-08, 1404/02/18
Registrant information
Name
Reza Mazloumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3626 0001
Email address
fatalprowling@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-22, 1404/04/01
Expected recruitment end date
2026-06-22, 1405/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical comparison of two submental intubation methods (Altmeyer and Seldinger) in patients candidates for fixation of maxillofacial injuries
Public title
Comparison of two submental intubation methods (Altmeyer and Seldinger) in fixation of maxillofacial injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for fixation of maxillofacial injuries Need for submental intubation
Exclusion criteria:
Patients with traumatic brain injury Patients with coagulopathy Patients with psychiatric illnesses Patients with polytrauma requiring multiple surgeries Patients requiring long-term respiratory support
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of eligible patients is done in random blocks of 4 using the RAND option of Excel software. Then, for concealment, a code is considered for each of the samples and a coded envelope is allocated and sealed in the envelope. None of the people present in the study are aware of the groupings from the time of allocation to the implementation.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessors, the patient's caregivers, including nurses and paramedics, were unaware of the type of intervention performed. The only person performing the procedure (surgeon) was informed of the grouping and type of intervention for each group only at the time of the procedure, due to the need for correct and standardized implementation. When recording data, the groups were recorded as A and B, and the statistical analyst was unaware of which type of intervention each group belonged to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Dentistry Faculty of Shahid Sadoughi University of Medical Sciences Yazd
Street address
Faculty of Dentistry, Marat Blvd, Imam Reza Blvd, Deha Fajr Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2024-09-22, 1403/07/01
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1403.040

Health conditions studied

1

Description of health condition studied
submental intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation

Primary outcomes

1

Description
Time required for intubation
Timepoint
The time required for intubation is measured from the onset of anesthesia and the initiation of intubation to connection to the mechanical ventilator.
Method of measurement
The time interval between the incision or needle passage and the ventilator connection

2

Description
bleeding
Timepoint
Bleeding is recorded from the beginning of the intervention to the end of the surgery.
Method of measurement
Bleeding score according to the Ramaraj scale

3

Description
Skin scar
Timepoint
At 1 and 3-month follow-up after intervention
Method of measurement
vancover scar test

Secondary outcomes

empty

Intervention groups

1

Description
In patients assigned to the Altemir group, submental intubation is performed using the classic Altemir technique. First, the patient’s head and neck are extended, and the submental region is thoroughly disinfected. Adhering strictly to sterile technique, a 1.5–2 cm skin incision is made in the paramedian submental area, approximately 1 cm below and parallel to the lower mandibular margin, at the junction of the medial one-third and lateral two-thirds of the distance between the mandibular symphysis and the mandibular angle. The side for submental intubation is chosen based on the location of any mandibular fractures.Next, a medium-sized arterial forceps is used to perform blunt dissection from the skin incision toward the floor of the mouth, following the lingual aspect of the mandible. The tips of the arterial forceps tent the mucosa of the floor of the mouth and then enter the oral cavity. Inside the mouth, the tongue is retracted to the opposite side for improved visualization, thereby creating the submental tunnel. The tunnel is then progressively dilated by opening the forceps.After thorough suctioning of oral secretions, the cuff of the endotracheal tube (ETT) is completely deflated, and the pilot balloon is grasped with the arterial forceps and pulled through the submental tunnel. Once exteriorized, the cuff is reinflated. The forceps are reinserted through the tunnel into the mouth, and the universal connector of the oral ETT is disconnected from the ventilator circuit and removed. The ETT is then grasped with the forceps, withdrawn through the submental tunnel, and positioned in the submental region. Finally, the submental ETT is reconnected—via its universal connector—to the respiratory circuit.
Category
Treatment - Surgery

2

Description
Intervention Group 2 (Seldinger Technique):In patients assigned to the Seldinger group, submental intubation is performed using a percutaneous tracheostomy kit. First, the patient’s head and neck are extended, and the submental region is thoroughly disinfected. Under strict sterile conditions, a needle with its introducer sheath is inserted into the paramedian submental area—approximately 1 cm below and parallel to the lower mandibular margin, at the junction of the medial one-third and lateral two-thirds of the distance between the mandibular symphysis and angle. Once the needle tip appears in the oral cavity, the needle is withdrawn, leaving the sheath in place.Next, a guidewire is passed through the sheath. As soon as the guidewire enters the mouth, an assistant secures it firmly. An introducer tube is then advanced over the guidewire to establish the submental tract. The tract is progressively dilated using a dilator, which is rotated over the guidewire. When sufficient dilation is achieved, a medium-sized arterial forceps is passed through the tract until its tips emerge into the oral cavity.After complete suctioning of oral secretions, the cuff of the endotracheal tube (ETT) is fully deflated, and the pilot balloon is grasped with the arterial forceps and pulled through the submental tunnel. The cuff is then reinflated. Next, the arterial forceps is reinserted through the submental tunnel into the mouth; the universal connector of the oral ETT is disconnected from the ventilator circuit and removed. The ETT is then firmly grasped with the forceps and withdrawn through the submental tunnel until its tip lies in the submental region. Finally, the submental ETT is reconnected—via its universal connector—to the respiratory circuit.Demographic data and the time required to complete each intubation procedure—defined as “incision time” in the Altemir technique and as “needle-to-reconnection time” in the Seldinger technique—will be recorded. Apnea duration (time needed to convert from oral to submental intubation), intraoperative complications such as damage to the ETT or its components, difficulty dilating the tract, or tissue entrapment during pilot balloon inflation will also be documented.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rahnemoon hospital
Full name of responsible person
Reza Mazloumi
Street address
Shahid Rahnemoon hospital, Farokhi blv, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0001
Email
mazlomireza054@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amir Houshang Mehrparvar
Street address
Deputy of Research and Technology, Shahid Sadoughi University of Medical Sciences, Imam Reza (AS) Educational and Research Complex, Beginning of Daneshjoo Boulevard, Imam Hossein (AS) Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Phone
+98 35 3626 0001
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reza Mazloumi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Rahnemoon hospital, Farokhi blv, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0001
Email
mazlomireza054@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reza Mazloumi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Secretariat, Shahid Rahnamoon Hospital, Farrokhi St., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0001
Email
mazlomireza054@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reza Mazloumi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Rahnemoon hospital, Farokhi blv, Yazd, Iran
City
yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0001
Email
mazlomireza054@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
Access begins one month after publication of this clinical trial study article.
To whom data/document is available
All researchers working in educational and medical institutions around the world can access the data.
Under which criteria data/document could be used
After the publication of the article resulting from this project, researchers can request access to the project data by sending an email to the address of the responsible author of the project, and within one month, coded information without personal patient information will be sent to the researchers.
From where data/document is obtainable
After the publication of the article resulting from this project, researchers can request access to the project data by sending an email to the address of the responsible author of the project, and within one month, coded information without personal patient information will be sent to the researchers.
What processes are involved for a request to access data/document
After the publication of the article resulting from this project, researchers can request access to the project data by sending an email to the address of the responsible author of the project, and within one month, coded information without personal patient information will be sent to the researchers.
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