Apneic Oxygenation Clinical Trial
Official title:
A Randomized Control Trial to Assess the Effectiveness of Apneic Oxygenation in Adults Using Low Flow or High Flow Nasal Cannula With Head Side Elevation Compared With Usual Care to Prevent Desaturation During Endotracheal Intubation
Apneic oxygenation is a process of delivering continuous oxygen during direct laryngoscopy. Nasal cannulas are used for the purpose of oxygenation; for delivering either low flow or high flow oxygen but haven't been tested in terms of a superior study design on improving patient outcomes. In this study the investigators propose to assess the effect of giving low flow oxygen with head side elevation versus high flow oxygen with head side elevation against the usual practice of care in which no oxygen is provided during direct laryngoscopy on participant's oxygenation level. This will be a three arm study instituting block randomization technique. There will be no blinding due to the nature of intervention. The primary outcomes are lowest non-invasive oxygen saturation measurement during direct laryngoscopy and two minutes after the placement of the tube and first pass success rate. The intervention is unique as the investigators have introduced head side elevation up to 30 degrees for improving glottis visualization and low or high flow oxygen delivery on grounds to improve oxygenation for patient safety undergoing endotracheal intubation. The technique if proved successful can be employed as a method of airway management in the emergency room. The results of the study will open new horizons for the development of guidelines to utilize it as a routine measure, during airway management in the emergency room.
Intervention (High Flow and Low Flow):
The participants after fulfilling the eligibility criteria will be randomly assigned to the
respective arm (High Flow, Low Flow or Standard). For procedure, depending upon the arm, the
head side of the patient bed will be elevated up to 30 degrees in order to better visualize
the glottis. The participants in the high flow oxygen delivery through nasal cannula
preoxygenation will be set for 4 min at 6 L/min through humidified and heated pure oxygen
(fraction of inspired oxygen 100%, 37C). Similarly, participant in the low flow oxygen
delivery through nasal cannula preoxygenation will be set for 4 min at 3 L/min through
humidified and heated pure oxygen (faction of inspired oxygen 100%, 37C). Throughout the
procedure the high flow nasal cannula or low flow nasal cannula will be maintained trying to
achieve a continuous oxygen during direct laryngoscopy for RSI.
Standard Arm:
In the standard arm the head end of the bed will not be raised to 30 degrees instead the
whole bed is raised up to the operator belly button in order to ease glottis visualization.
In the standard group the preoxygenation is for 4 min or till achievement of peripheral
oxygen saturation greater than 95% with a face mask that will be connected to the oxygen port
at 10 L/min. During the direct laryngoscopy there will be no insufflation of oxygen through
nasal cannula or face mask.
Data collection:
Research staff involved in collecting data, will be independent from primary research team in
order to minimize observer bias. The oxygen saturations will be recorded using pulse oximetry
(through a standard infrared oximetry tape) exclusively used for research purpose and will
record time using stop watch (Casio Digital Stop Watch) during and after the procedure. The
operator will report research staff about all subjective assessments of difficult intubation
and airway complications during procedure on the data collection tool. The operator while
performing the direct laryngoscopy, if experience difficulty as per Corkman Lehman grade,
will inform research staff for protocol deviation.
Intubation attempts (number of time laryngoscope blade placed in the mouth) will be counted
for each patient. In those patients where first pass is failed and subsequent attempt is made
without assisted ventilation, the apnea time will be noted as mentioned above. To confirm the
accuracy of data collected, the investigators will conduct a concurrent assessment of the
outcomes for a convenience sample of 10% of enrolled participants.
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