Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/18/2019 |
| Start Date: | January 15, 2019 |
| End Date: | December 31, 2019 |
| Contact: | Carin Hagberg |
| Email: | chagberg@mdanderson.org |
| Phone: | 713-563-0223 |
Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial
This trial studies how well flexible intubation scope with or without video laryngoscope
works in supporting endotracheal tube placement in patients with head and neck cancer before
surgery. Flexible intubation scope and video laryngoscope are devices that have a small
camera to help the doctor see the patient's airway on a screen. Both devices may help the
doctor who gives anesthesia prevent complications from placing the breathing tube (such as
pain or mouth injury).
works in supporting endotracheal tube placement in patients with head and neck cancer before
surgery. Flexible intubation scope and video laryngoscope are devices that have a small
camera to help the doctor see the patient's airway on a screen. Both devices may help the
doctor who gives anesthesia prevent complications from placing the breathing tube (such as
pain or mouth injury).
PRIMARY OBJECTIVES:
I. To compare the rates of difficult endotracheal tube (ETT) placement using a flexible
intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in
difficult airway management.
SECONDARY OBJECTIVES:
I. To compare the ease of using a flexible intubation scope (FIS) with and without the use of
the video laryngoscope (VL).
II. Total time for securing the airway. III. Number of attempts required for intubation. IV.
Rate of failure at intubation. V. Incidence of desaturation. VI. Assessment for hoarseness,
sore mouth, neck, or jaw, dysphonia, dysphagia, lip injury, tongue injury, or tooth damage.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo flexible scope intubation up to 2 attempts following induction of
general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients
undergo a third attempt utilizing another technique or device.
ARM B: Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts
following induction of general anesthesia and adequate manual ventilation. In case of failed
2 attempts, patients undergo a third attempt utilizing another technique or device.
I. To compare the rates of difficult endotracheal tube (ETT) placement using a flexible
intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in
difficult airway management.
SECONDARY OBJECTIVES:
I. To compare the ease of using a flexible intubation scope (FIS) with and without the use of
the video laryngoscope (VL).
II. Total time for securing the airway. III. Number of attempts required for intubation. IV.
Rate of failure at intubation. V. Incidence of desaturation. VI. Assessment for hoarseness,
sore mouth, neck, or jaw, dysphonia, dysphagia, lip injury, tongue injury, or tooth damage.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo flexible scope intubation up to 2 attempts following induction of
general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients
undergo a third attempt utilizing another technique or device.
ARM B: Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts
following induction of general anesthesia and adequate manual ventilation. In case of failed
2 attempts, patients undergo a third attempt utilizing another technique or device.
Inclusion Criteria:
- All head and neck elective surgical patients with known or suspected difficult airways
that meet at least three (3) of the difficult airway criteria [Mallampati III-IV, neck
circumference > 40 cm, sternomental distance < 12 cm, thyromental distance < 6 cm,
mouth opening < 4 cm, body mass index (BMI) · 35 kg/m^2, Upper Lip Bite Test - ULBT
(class III)] or history of radiation to the head and neck area or oral pathology
obstructing the glottic view
- American Society of Anesthesiology (ASA) I-IV
- Has provided written informed consent
Exclusion Criteria:
- Active bleeding from nasopharynx or oropharynx
- Trismus
- Oral pathology obstructing the glottic view
- Planned awake or nasal intubation
- Neuromuscular blockade (NMB) contraindicated post-induction
- Emergency endotracheal intubation and patients intubated pre and post-surgery
- Surgical procedures such as tracheostomy, laryngectomy, esophagectomy
- Pregnant females
- American Society of Anesthesiology (ASA) V
- Patient refusal or inability to consent for study participation
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Carin A. Hagberg
Phone: 713-563-0223
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