The purpose of this study is to assess and compare the conditions for tracheal intubation obtained with Modified Time Principle Induction (MTPI) and that obtained with classic induction (CI). This study will compare the efficiency of tracheal intubation with the two induction techniques, as well as evaluate for potential adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
154
Patients from both study groups will receive premedication in the usual fashion, typically 0-2 mg of IV midazolam at the discretion of the care team. Patients in both study groups will receive 1 mg/kg of lidocaine intravenously, followed by an opioid such as fentanyl (1-2 mcg/kg), prior to administration of induction drugs. Patients assigned to MTPI will then be given rocuronium (0.6mg/kg), followed by propofol intravenously as a single bolus within 10 seconds. A typical propofol bolus for induction ranges from 1-2mg/kg, depending on the patient's age, medical history, and co-morbidities. Propofol dosing will be at the discretion of the care team. Patients will count down from one hundred. Once apnea occurs, as indicated by a lack of respiratory effort, the eyes will be taped, and intubation with C-MAC (Karl Storz 8403ZX, Tuttlingen, Germany) is initiated.
Patients assigned to CI will be induced as per routine care using lidocaine 1 mg/kg, an opioid such a fentanyl (1-2 mcg/kg), propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg, and the intubation will be performed with a C-MAC. Patients will also count down from one hundred. The medications used for induction of anesthesia in both arms of the study are those used for routine anesthesia care. In both study arms, dosing of medications for induction of anesthesia is standardized (lidocaine 1 mg/kg, fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg). The only difference between the two arms will be the timing of the medication administration, and the order in which medications are administered. The documentation of induction and intubation will be the same as that of the MTPI group. Vital signs and other parameters will continuously be recorded in the intraoperative record. Emergence and extubation are not protocolized.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation
Time frame: Between laryngoscope insertion to onset of ventilation (less than 7 minutes)
Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt
Time frame: after 5 minutes of successful ventilation
Number of Times Tracheal Intubations Are Attempted
Time frame: after 5 minutes of successful ventilation
Number of Participants for Whom Tracheal Intubations Failed
Time frame: after 3 failed intubation attempts (less than 7 minutes from start of intubation)
Airway Cord View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
The Cormack-Lehane classification system is a method used to categorize the airway view at the time of laryngoscopy. Data is reported categorically as follows 1(Full view of glottis),2(Partial view of glottis), 3(Only epiglottis seen, none of glottis seen) and 4(Neither glottis nor epiglottis seen)
Time frame: from start of induction to 5 minutes of successful ventilation
Minimum Systolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Systolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Diastolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
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Maximum Diastolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Heart Rate
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Heart Rate
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Oxygen Saturation (SpO2)
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Oxygen Saturation (SpO2)
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Expired Tidal Volume
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
End-tidal Carbon Dioxide (CO2) Level
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Number of Participants That Had Injury Associated With Intubation
Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed
Time frame: within 24 hours after surgery
Physical Response During Intubation, as Assessed by the Number of Participants Who Moved
Time frame: during surgery
Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed
Time frame: during surgery
Number of Participants Who Had Awareness of Muscle Paralysis Before Loss of Consciousness as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Awareness of Muscle Paralysis or Weakness before loss of consciousness was assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction through in person interviews to evaluate explicit and implicit recall. Number of Participants with Positive Explicit recall and Positive Implicit recall are reported. Explicit recall: Participants were asked, "Describe the last thing you remember before falling asleep." If the participant describes memories of paralysis or awareness of the intubation event this is classified as positive explicit recall. If none of these memories are described it is considered negative explicit recall. Implicit recall: Participants with negative explicit recall, were asked "Did you ever feel weakness or paralysis as you fell asleep?" If they answered yes, this is classified as positive implicit recall.
Time frame: within one hour after surgery
Level of Throat Soreness as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Level of throats soreness is scored from 0(no pain) to 10(worst pain), a higher number indicating worse throat soreness.
Time frame: within one hour after surgery
Number of Participants Who Had Nausea as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time frame: within one hour after surgery
Overall Patient Satisfaction as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Patient satisfaction is scored from 0(not satisfied) to 10(extremely satisfied), a higher number indicating greater satisfaction.
Time frame: within one hour after surgery
Number of Participants Who Had Recollection of Pain on Induction
Time frame: within one hour after surgery
Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult"
Time frame: at time of surgery
Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time frame: within one hour after surgery