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IRCT20250419065388N1 IRCT 2025-05-08 Yazd University of Medical Sciences Comparison of two submental intubation methods (Altmeyer and Seldinger) in fixation of maxillofacial injuries Clinical comparison of two submental intubation methods (Altmeyer and Seldinger) in patients candidates for fixation of maxillofacial injuries 2025-06-22 anticipated 22 Complete https://irct.ir/trial/83019 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A submental intubation. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: Access begins one month after publication of this clinical trial study article. To whom: All researchers working in educational and medical institutions around the world can access the data. Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public Reza Mazloumi
Shahid Rahnemoon hospital, Farokhi blv, Yazd, Iran
Yazd Iran (Islamic Republic of) 8913814396 +98 35 3626 0001 mazlomireza054@gmail.com Yazd University of Medical Sciences scientific Reza Mazloumi
Secretariat, Shahid Rahnamoon Hospital, Farrokhi St., Yazd, Iran
Yazd Iran (Islamic Republic of) 8913814396 +98 35 3626 0001 mazlomireza054@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for fixation of maxillofacial injuries Need for submental intubation 20 years 60 years Both Patients with traumatic brain injury Patients with coagulopathy Patients with psychiatric illnesses Patients with polytrauma requiring multiple surgeries Patients requiring long-term respiratory support T88.4 Failed or difficult intubation Treatment - Surgery Treatment - Surgery 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. 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. 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. 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. Skin scar. Timepoint: At 1 and 3-month follow-up after intervention. Method of measurement: vancover scar test. Yazd University of Medical Sciences Approved 2024-09-22 Ethics Committee of Dentistry Faculty of Shahid Sadoughi University of Medical Sciences Yazd Faculty of Dentistry, Marat Blvd, Imam Reza Blvd, Deha Fajr Blvd, Yazd Yazd Yazd Iran (Islamic Republic of)