Anesthesia, Endotracheal, Surgery
Conditions
Keywords
laryngoscope, intubation, first attempt success, oxygen saturation, airway management, Videolaryngoscopy, Direct laryngoscopy
Brief summary
Complications related to infant (≤ 1 year) airway management are under-appreciated because of few rigorous and targeted studies. Investigators have recently shown that multiple tracheal intubation (TI) attempts are a key risk factor for intubation-related complications in small children. Tracheal Intubation using Video laryngoscopy (VL) has become popular in anesthesiology practice because of several advantages over conventional direct laryngoscopy (DL). Studies show that VL improves the view of the airway compared to DL, requires fewer intubation attempts, but may take more time to intubate the trachea. This study compares first attempt success of VL to DL in infants presenting for elective surgery.
Detailed description
Objectives: * Primary Objective To compare the tracheal intubation (TI) first attempt success rate using VL vs. DL in children ≤ 12 months old. * Secondary Objectives To compare the lowest oxygen saturation during tracheal intubation with VL vs. DL. Study Design: Prospective, randomized, multi-center parallel group trial Setting/Participants: This will be a multi-center study with a minimum of four participating centers. The target population will be children ≤ 12 months age scheduled for elective surgery requiring general anesthesia with endotracheal intubation. Study Interventions and Measures: The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Miller 1 (VL) or the conventional Miller laryngoscope (DL). Main study outcome measures are as follows: * The first intubation attempt success rate with each device * The number of attempts for successful intubation with each device * Complications associated with intubation
Interventions
DEVICEVideo Laryngoscopy for ET placement
Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
DEVICEDirect Laryngoscopy for ET Placement
Tracheal Intubation performed with the Miller Blade
Sponsors
Anesthesia Patient Safety Foundation
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician will be blinded at the time of data analysis.
Intervention model description
Prospective, randomized, multi-center parallel group trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
Inclusion criteria
1. Males or females age 0 to \<12 months. 2. Scheduled for non-cardiac surgery or procedure lasting longer than 30 minutes under general anesthesia where oral endotracheal intubation will be performed by an anesthesiology clinician. 3. Subject/Parental/guardian permission (informed consent). Inclusion for clinician participants: 1\) Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident
Exclusion criteria
1. History of difficult intubation 2. History with abnormal airway 3. Predictive of difficult intubation upon physical examination 4. Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Success in the First Attempt | at the time of intubation | comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxia | At the time of intubation | Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL |
Countries
Australia, United States
Participant flow
Recruitment details
The study was recruited per protocol without any protocol deviation or violation.
Pre-assignment details
The block size was varying among 2, 4, 6 to avoid the predictability of device assignment. To further balance device assignment, we'll stratify the randomization by study site and clinician's role. Separate randomization schedule was generated for each stratum.
Participants by arm
| Arm | Count |
|---|---|
| Video Laryngoscopy for Endotracheal (ET) Placement Device:
Storz C-MAC Video Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade | 274 |
| Direct Laryngoscopy for ET Placement Device:
Miller Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade | 277 |
| Total | 551 |
Baseline characteristics
| Characteristic | Video Laryngoscopy for Endotracheal (ET) Placement | Direct Laryngoscopy for ET Placement | Total |
|---|---|---|---|
| Age, Customized 0-30 Days | 17 Participants | 20 Participants | 37 Participants |
| Age, Customized 31-90 Days | 55 Participants | 64 Participants | 119 Participants |
| Age, Customized > 90 Days | 202 Participants | 193 Participants | 395 Participants |
| ASA 1 - Normal | 58 Participants | 72 Participants | 130 Participants |
| ASA 2 - Mild systemic disease | 133 Participants | 136 Participants | 269 Participants |
| ASA >= 2 - Mod - Severe systemic disease | 83 Participants | 69 Participants | 152 Participants |
| Device experience as number of infant intubations 0 | 38 Participants | 10 Participants | 48 Participants |
| Device experience as number of infant intubations 1-10 | 79 Participants | 59 Participants | 138 Participants |
| Device experience as number of infant intubations 11-20 | 36 Participants | 36 Participants | 72 Participants |
| Device experience as number of infant intubations 21-50 | 49 Participants | 37 Participants | 86 Participants |
| Device experience as number of infant intubations >50 | 62 Participants | 128 Participants | 190 Participants |
| Device experience as number of infant intubations Unknown | 10 Participants | 7 Participants | 17 Participants |
| Induction Technique -IV | 28 Participants | 39 Participants | 67 Participants |
| Muscle Relaxant None | 15 Participants | 14 Participants | 29 Participants |
| Muscle Relaxant Other | 250 Participants | 252 Participants | 502 Participants |
| Muscle Relaxant Succinylcholine | 9 Participants | 11 Participants | 20 Participants |
| Provider Role Anes Attending | 69 Participants | 69 Participants | 138 Participants |
| Provider Role Anes Fellow | 99 Participants | 102 Participants | 201 Participants |
| Provider Role Anes Resident | 106 Participants | 106 Participants | 212 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 79 Participants | 96 Participants | 175 Participants |
| Sex: Female, Male Male | 195 Participants | 181 Participants | 376 Participants |
| Weight (kg) | 6.5 kg | 6.6 kg | 6.5 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 274 | 0 / 277 |
| other Total, other adverse events | 3 / 274 | 2 / 277 |
| serious Total, serious adverse events | 0 / 274 | 0 / 277 |
Outcome results
Primary
Number of Participants With Success in the First Attempt
comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL
Time frame: at the time of intubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Laryngoscopy for Endotracheal (ET) Placement | Number of Participants With Success in the First Attempt | 253 Participants |
| Direct Laryngoscopy for ET Placement | Number of Participants With Success in the First Attempt | 243 Participants |
Secondary
Hypoxia
Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL
Time frame: At the time of intubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Laryngoscopy for Endotracheal (ET) Placement | Hypoxia | 9 Participants |
| Direct Laryngoscopy for ET Placement | Hypoxia | 15 Participants |