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
The ease of intubation and Hemodynamic stability during difficult airway management is compared with oral and nasal intubation in patients with acute burns.
Design
Clinical trial, with single-blind, randomized groups, on 20 patients.Random number table was used for randomization.
Settings and conduct
Many patients with acute burns develop progressive airway obstruction and respiratory distress due to severe head, face, and upper extremity injuries. Tracheal intubation after local anesthesia in the patient's throat can be performed blindly with only mild sedation.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1) Patients aged 18 to 57 years with acute head and face burns and are candidates for emergency intubation due to progressive airway obstruction or severe hypoxia (SPaO2 <90%)
2) They have a problem airway (Malampati Ⅲ and Ⅳ).
exclusion criteria:
1) The patient is not breathing
2) Severe restlessness
3) Shock
4) Patient with a history of previous underlying disease (severe liver disease, severe hemodynamic disorder and disease with coagulation disorder)
5) Hypertension
6) Taking anticoagulants
7) Trauma to the head, face and neck
8) Have rhinoplasty
Intervention groups
Group O: Group O patients are intubated according to the protocol after administration of midazolam , fentanyl , ketamine , and laryngoscopy.
Group N: Patients in group N are pre-oxygenated and intubated after administration of topical lidocaine in the pharynx..
Main outcome variables
* Airway management status
* Hemodynamic stability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140421017372N2
Registration date:2022-02-01, 1400/11/12
Registration timing:registered_while_recruiting
Last update:2022-02-01, 1400/11/12
Update count:0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Reza Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2249 7975
Email address
salehi.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 57 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
In this study, patients are unaware of the method to be used in intubation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-01-03, 1399/10/14
Ethics committee reference number
IR.IUMS.FMD.REC.1399.545
Health conditions studied
1
Description of health condition studied
Acute head and neck burns
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Number of endotracheal tubes consumed
Timepoint
First entry - during intubation - 5 minutes after intubation
Method of measurement
Counting by the nurse
2
Description
blood pressure
Timepoint
First entry - during intubation - 5 minutes after intubation
Method of measurement
Mercury barometer
3
Description
Respiratory Rate
Timepoint
First entry - during intubation - 5 minutes after intubation
Method of measurement
Pulse oximetry
4
Description
Arterial oxygen saturation level
Timepoint
First entry - during intubation - 5 minutes after intubation
Method of measurement
Pulse oximetry
5
Description
heart rate
Timepoint
First entry - during intubation - 5 minutes after intubation
Method of measurement
Chest lead connected to the monitor
6
Description
Number of intubation attempts
Timepoint
First entry - during intubation - 5 minutes after intubation
Method of measurement
Counting with the help of a nurse
7
Description
Apnea and cardiac arrest
Timepoint
First entry - during intubation - 5 minutes after intubation
Method of measurement
by nurse
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.