Anesthesia
Conditions
Brief summary
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.
Interventions
DRUGMTPI
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.
DRUGClassic Induction
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BMI \>30 kg/M2 or Mallampati class III or IV * Requiring general anesthesia and endotracheal intubation
Exclusion criteria
* Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma * American Society of Anesthesiologists (ASA) physical status classification \> III * Emergency surgery * Induction requiring cricoid pressure * Patients requiring awake intubation * Pregnant women * Patients who require an induction dose of propofol less than 1 mg/kg * Untreated ischemic heart disease * Contraindication to mask ventilation * Allergy to propofol, rocuronium, or Sugammadex * Induction requiring succinylcholine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation | Between laryngoscope insertion to onset of ventilation (less than 7 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Response During Intubation, as Assessed by the Number of Participants Who Moved | during surgery | — |
| Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed | during surgery | — |
| Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt | after 5 minutes of successful ventilation | — |
| Number of Times Tracheal Intubations Are Attempted | after 5 minutes of successful ventilation | — |
| Number of Participants for Whom Tracheal Intubations Failed | 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) | from start of induction to 5 minutes of successful ventilation | 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) |
| Minimum Systolic Blood Pressure | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| Maximum Systolic Blood Pressure | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| Minimum Diastolic Blood Pressure | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| Maximum Diastolic Blood Pressure | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| Minimum Heart Rate | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| Maximum Heart Rate | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| Minimum Oxygen Saturation (SpO2) | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| Maximum Oxygen Saturation (SpO2) | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| Expired Tidal Volume | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| End-tidal Carbon Dioxide (CO2) Level | from the start of induction drug administration to about 5 minutes after successful ventilation | — |
| 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 | within one hour after surgery | 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. |
| Level of Throat Soreness as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | within one hour after surgery | Level of throats soreness is scored from 0(no pain) to 10(worst pain), a higher number indicating worse throat soreness. |
| Number of Participants Who Had Nausea as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | 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 | within one hour after surgery | Patient satisfaction is scored from 0(not satisfied) to 10(extremely satisfied), a higher number indicating greater satisfaction. |
| Number of Participants Who Had Recollection of Pain on Induction | within one hour after surgery | — |
| Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult" | at time of surgery | — |
| Number of Participants That Had Injury Associated With Intubation | within 24 hours after surgery | Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed |
| Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | within one hour after surgery | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLauren M Nakazawa, MD, MBA
The University of Texas Health Science Center, Houston
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 15.1 |
| American Society of Anesthesiology (ASA) Classification ASA I: A normal healthy patient | 2 Participants |
| American Society of Anesthesiology (ASA) Classification ASA II: A patient with mild systemic disease | 22 Participants |
| American Society of Anesthesiology (ASA) Classification ASA III: A patient with severe systemic disease | 38 Participants |
| American Society of Anesthesiology (ASA) Classification ASA IV: A patient with severe systemic disease that is a constant threat to life | 1 Participants |
| BMI | 37.7 kg/m^2 STANDARD_DEVIATION 8 |
| Height | 169.7 centimeters STANDARD_DEVIATION 10.9 |
| Mallampati class Class I | 15 Participants |
| Mallampati class Class II | 29 Participants |
| Mallampati class Class III | 17 Participants |
| Mallampati class Class IV | 4 Participants |
| Mallampati class Unknown | 4 Participants |
| Patients with both BMI ≥ 30 and Mallampati class ≥ 3 | 20 Participants |
| Providers' training levels Anesthesia assistants | 14 Participants |
| Providers' training levels Anesthesia residents | 45 Participants |
| Providers' training levels Attending Anesthesiologists | 8 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 28 Participants |
| Weight | 110.8 Kilograms STANDARD_DEVIATION 28.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 77 |
| other Total, other adverse events | 0 / 77 | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
None listed