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IRCT20140421017372N2 IRCT 2022-02-01 Iran University of Medical Sciences Comparison of the effect of endotracheal intubation through the mouth and nose on the ease of intubation and cardiovascular status during intubation of patients with acute burns with severe airway obstruction. Comparison of the effect of oro-tracheal (classical) and naso-tracheal (blindly) intubation methods on ease of airway management and hemodynamic stability during intubation of acute burn patients with difficult airway condition 2021-12-22 anticipated 20 Complete https://irct.ir/trial/59307 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block type is used for limited randomization. In this way, patients are divided into two groups by block randomization. Assignment Sequences Using Web Systems Produced by www-sealedenvelope.com/. In order to create an allocation sequence in this system, the number of subjects in each block was determined as 2 people. Thus, the letter o was created for the group that is intubated orally and the N group was created for the group that is intubated nasally, and finally, by confirming the allocation sequence in the above system, 10 allocation sequences were created for 20 samples by combining the letters N and O. Then the cards containing the blocks are placed inside the opaque envelope, thus concealing the allocation is also considered and observed, Blinding description: In this study, patients are unaware of the method to be used in intubation. N/A Acute head and neck burns. Intervention 1: Intervention group: Patients in group N are initially pre-oxygenated for 5 minutes and after administering a total of 6 puffs of 10% topical lidocaine in the nasopharynx, uro and hypopharynx, pass the endotracheal tube through the nostrils and intubate the patient with the help of breathing sound. We do. Intervention 2: Control group: Patients in group O are intubated according to the usual method after administration of midazolam (0.03 mg / kg), fentanyl (2 /g / kg), ketamine (1.5 kg / min) and laryngoscopy. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome, can be shared. When: Access period starts 3 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: The data of this study can only be used in the field of research. Where to obtain: Refer to Dr. Reza Salehi. How to obtain: After sending the request and approval by Dr. Salehi et al., The data will be sent. Comments:
public Shayan Sanati
Hazrate Rasoole Akram Hospital, Niayesh St, Satarkhan Av, Tehran, IRAN
Tehran Iran (Islamic Republic of) 1445613131 +98 21 8880 4527 shayansanati@yahoo.com Iran University of Medical Sciences scientific Reza Salehi
Burn Motehari Hospital, Yasemi St., Vali-Asr St.,Vanak Sq.
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8877 0031 salehi.r@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with acute burns of the head and face Patients with progressive airway obstruction or severe hypoxia are candidates for emergency intubation difficult airway (Mallampati Ⅲ and Ⅳ) Patients should have spontaneous breathing 18 years 57 years Both Patient without spontaneous breathing Patient with a history of underlying heart disease (severe liver disease, severe hemodynamic disorder and coagulation disorder) Hypertension Taking anticoagulants Trauma to the head, face and neck nose surgery and nose anomaly severe restlessness Treatment - Drugs Treatment - Drugs Intervention group: Patients in group N are initially pre-oxygenated for 5 minutes and after administering a total of 6 puffs of 10% topical lidocaine in the nasopharynx, uro and hypopharynx, pass the endotracheal tube through the nostrils and intubate the patient with the help of breathing sound. We do. Control group: Patients in group O are intubated according to the usual method after administration of midazolam (0.03 mg / kg), fentanyl (2 /g / kg), ketamine (1.5 kg / min) and laryngoscopy. Number of endotracheal tubes consumed. Timepoint: First entry - during intubation - 5 minutes after intubation. Method of measurement: Counting by the nurse. Blood pressure. Timepoint: First entry - during intubation - 5 minutes after intubation. Method of measurement: Mercury barometer. Respiratory Rate. Timepoint: First entry - during intubation - 5 minutes after intubation. Method of measurement: Pulse oximetry. Arterial oxygen saturation level. Timepoint: First entry - during intubation - 5 minutes after intubation. Method of measurement: Pulse oximetry. Heart rate. Timepoint: First entry - during intubation - 5 minutes after intubation. Method of measurement: Chest lead connected to the monitor. Number of intubation attempts. Timepoint: First entry - during intubation - 5 minutes after intubation. Method of measurement: Counting with the help of a nurse. Apnea and cardiac arrest. Timepoint: First entry - during intubation - 5 minutes after intubation. Method of measurement: by nurse. Iran University of Medical Sciences Approved 2021-01-03 Ethics committee of Iran University of Medical Sciences Tehran, Hemmat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)