Respiratory Failure
Conditions
Keywords
Endotracheal Intubation, Apneic Oxygenation, Respiratory failure
Brief summary
Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically ill patients. Procedural complications including failed attempts at intubation, esophageal intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death are common in this setting. While there are many important components of successful airway management in critical illness, the maintenance of adequate arterial hemoglobin saturation from procedure initiation until endotracheal tube placement is paramount as desaturation is the most common factor associated with peri-intubation cardiac arrest and death. Interventions that either shorten the duration of time required for tube placement or prolong the period before desaturation may be effective in improving outcome. The high rate of complications and the lack of existing evidence regarding the efficacy of current airway management techniques in shortening the time to airway establishment or prolonging the time to desaturation mandates further investigation. The primary hypothesis is that video laryngoscopy will be superior to direct laryngoscopy in successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) of medical ICU patients by Pulmonary/Critical Care Medicine fellows after controlling for the operator's past number of procedures with the equipment used. Also, the investigators hypothesize that the provision of apneic oxygenation during the endotracheal intubation procedure (defined as a nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure) will result in a higher arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) compared to no apneic oxygenation.
Interventions
DEVICEVideo Laryngoscopy
DEVICEApneic Oxygenation
DEVICEDirect Laryngoscopy
DEVICENo Apneic Oxygenation
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults * Medical ICU Patients * Require endotracheal intubation * Endotracheal intubation to be performed by Pulmonary/Critical Care Medicine Fellow * Sedation and/or neuromuscular blockade is planned for the procedure
Exclusion criteria
* Operators other than Pulmonary/Critical Care Medicine Fellows * The operator predetermines that the patient requires specific intubating equipment or oxygenation technique will be required for the safe performance of the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. | 1 hour | The primary outcome for the video laryngoscopy compared with direct laryngoscopy arm of the study will be the successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) after controlling for the operator's past number of procedures with the equipment used. |
| Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). | 1 hour | The primary outcome for the apneic oxygenation arm of the study is arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Lowest Arterial Oxygen Saturation During Procedure | 1 hour | Arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) adjusted for arterial oxygen saturation at the time of administering intubation drugs. |
| Ventilator-free Days | 28 days | Number of days alive and free of mechanical ventilation after endotracheal intubation |
| Procedure-related Mortality | 1 hour | Death within 1 hour of beginning the procedure |
| Grade View of the Glottis | 1 hour | Best Cormack-Lehane grade view of the glottis (grade 1-4) on first laryngoscopy attempt. Higher grades on the 1-4 scale indicate worse glottic views. |
| Number of Esophageal Intubations Per Group | 1 hour | Number of esophageal intubations Per Study Group |
| ICU-mortality | 28 days | Death from any cause in the ICU and at anytime after the procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Video Laryngoscopy and Apneic Oxygenation Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
and
A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure | 37 |
| Direct Laryngoscopy and Apneic Oxygenation Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
and
A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure | 40 |
| Video Laryngoscopy and no Apneic Oxygenation Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
and
No apneic oxygenation | 37 |
| Direct Laryngoscopy and No Apneic Oxygenation Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
and
No apneic oxygenation | 36 |
| Total | 150 |
Baseline characteristics
| Characteristic | Total | Direct Laryngoscopy and No Apneic Oxygenation | Video Laryngoscopy and no Apneic Oxygenation | Direct Laryngoscopy and Apneic Oxygenation | Video Laryngoscopy and Apneic Oxygenation |
|---|---|---|---|---|---|
| Acute Physiology and Chronic Health Evaluation II Score | 21 units on a scale STANDARD_DEVIATION 7 | 21 units on a scale STANDARD_DEVIATION 6 | 23 units on a scale STANDARD_DEVIATION 6 | 21 units on a scale STANDARD_DEVIATION 6 | 21 units on a scale STANDARD_DEVIATION 9 |
| Age, Continuous | 58 years STANDARD_DEVIATION 14 | 58 years STANDARD_DEVIATION 12 | 56 years STANDARD_DEVIATION 15 | 58 years STANDARD_DEVIATION 14 | 58 years STANDARD_DEVIATION 15 |
| Body Mass Index | 29 kg/m^2 STANDARD_DEVIATION 8 | 29 kg/m^2 STANDARD_DEVIATION 8 | 28 kg/m^2 STANDARD_DEVIATION 5 | 29 kg/m^2 STANDARD_DEVIATION 9 | 29 kg/m^2 STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 3 Participants | 6 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 125 Participants | 32 Participants | 30 Participants | 30 Participants | 33 Participants |
| Region of Enrollment United States | 150 participants | 36 participants | 37 participants | 40 participants | 37 participants |
| Sex: Female, Male Female | 59 Participants | 15 Participants | 12 Participants | 17 Participants | 15 Participants |
| Sex: Female, Male Male | 91 Participants | 21 Participants | 25 Participants | 23 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 74 | 0 / 76 | 0 / 77 | 0 / 73 |
| serious Total, serious adverse events | 0 / 74 | 0 / 76 | 0 / 77 | 0 / 73 |
Outcome results
Primary
Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death).
The primary outcome for the apneic oxygenation arm of the study is arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death).
Time frame: 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Video Laryngoscopy | Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). | NA percent arterial oxygen saturation |
| Direct Laryngoscopy | Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). | NA percent arterial oxygen saturation |
| Apneic Oxygenation | Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). | 92 percent arterial oxygen saturation |
| No Apneic Oxygenation | Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). | 90 percent arterial oxygen saturation |
Primary
Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used.
The primary outcome for the video laryngoscopy compared with direct laryngoscopy arm of the study will be the successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) after controlling for the operator's past number of procedures with the equipment used.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Video Laryngoscopy | Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. | 51 participants |
| Direct Laryngoscopy | Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. | 50 participants |
| Apneic Oxygenation | Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. | NA participants |
| No Apneic Oxygenation | Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. | NA participants |
Secondary
Adjusted Lowest Arterial Oxygen Saturation During Procedure
Arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) adjusted for arterial oxygen saturation at the time of administering intubation drugs.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video Laryngoscopy | Adjusted Lowest Arterial Oxygen Saturation During Procedure | 88 PERCENT SATURATION | Standard Deviation 12 |
| Direct Laryngoscopy | Adjusted Lowest Arterial Oxygen Saturation During Procedure | 89 PERCENT SATURATION | Standard Deviation 12 |
| Apneic Oxygenation | Adjusted Lowest Arterial Oxygen Saturation During Procedure | 87 PERCENT SATURATION | Standard Deviation 12 |
| No Apneic Oxygenation | Adjusted Lowest Arterial Oxygen Saturation During Procedure | 82 PERCENT SATURATION | Standard Deviation 16 |
Secondary
Grade View of the Glottis
Best Cormack-Lehane grade view of the glottis (grade 1-4) on first laryngoscopy attempt. Higher grades on the 1-4 scale indicate worse glottic views.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video Laryngoscopy | Grade View of the Glottis | 1.24 units on a scale | Standard Deviation 0.43 |
| Direct Laryngoscopy | Grade View of the Glottis | 1.8 units on a scale | Standard Deviation 1.09 |
| Apneic Oxygenation | Grade View of the Glottis | 1.3 units on a scale | Standard Deviation 0.66 |
| No Apneic Oxygenation | Grade View of the Glottis | 1.75 units on a scale | Standard Deviation 0.77 |
Secondary
ICU-mortality
Death from any cause in the ICU and at anytime after the procedure
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Laryngoscopy | ICU-mortality | 19 Participants |
| Direct Laryngoscopy | ICU-mortality | 15 Participants |
| Apneic Oxygenation | ICU-mortality | 12 Participants |
| No Apneic Oxygenation | ICU-mortality | 17 Participants |
Secondary
Number of Esophageal Intubations Per Group
Number of esophageal intubations Per Study Group
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Video Laryngoscopy | Number of Esophageal Intubations Per Group | 0 number of esophageal intubations |
| Direct Laryngoscopy | Number of Esophageal Intubations Per Group | 1 number of esophageal intubations |
| Apneic Oxygenation | Number of Esophageal Intubations Per Group | 1 number of esophageal intubations |
| No Apneic Oxygenation | Number of Esophageal Intubations Per Group | 3 number of esophageal intubations |
Secondary
Procedure-related Mortality
Death within 1 hour of beginning the procedure
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Laryngoscopy | Procedure-related Mortality | 0 Participants |
| Direct Laryngoscopy | Procedure-related Mortality | 0 Participants |
| Apneic Oxygenation | Procedure-related Mortality | 0 Participants |
| No Apneic Oxygenation | Procedure-related Mortality | 1 Participants |
Secondary
Ventilator-free Days
Number of days alive and free of mechanical ventilation after endotracheal intubation
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video Laryngoscopy | Ventilator-free Days | 9 DAYS | Standard Deviation 12 |
| Direct Laryngoscopy | Ventilator-free Days | 12 DAYS | Standard Deviation 12 |
| Apneic Oxygenation | Ventilator-free Days | 14 DAYS | Standard Deviation 12 |
| No Apneic Oxygenation | Ventilator-free Days | 11 DAYS | Standard Deviation 12 |