To compare the efficacy of apnoeic oxygenation by nasopharyngeal airway vs nasal cannula vs THRIVE during airway management under general anaesthesia :A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the effect of apnoeic oxygenation by nasopharyngeal airway vs nasal cannula vs THRIVE in prolonging the duration of apnoea
研究概览
简要总结
Title of the study: To compare the efficacy of apnoeic oxygenation by nasopharyngeal airway vs nasal cannula vs THRIVE during airway management under general anaesthesia : A Prospective Randomised Controlled Trial
Primary Objective: To compare the efficacy of apnoeic oxygenation by nasopharyngeal airway vs nasal cannula vs THRIVE in prolonging the duration of apnoea up to a period of 8 minutes or till oxygen saturation (SpO2) is < 95% whichever is earlier
Secondary objective: 1. To assess the PaO2, PaCO2 after the induction of anesthesia and at the end of 8 minutes or when oxygen saturation falls to 95% whichever occurs earlier. 2. To assess SBP, DBP, MAP, HR every 30 seconds for 8 minutes or till SpO2 falls to 95%
Sample Size: Total 120 patients with 40 patients in each group
Randomisation: The patients will be randomised into three groups. Randomization will be done by using Sequentially Numbered Opaque Sealed Envelope technique concealig the randomization group as determined by a computer generated random numbers table.
Methodology:
All selected patients will undergo a routine pre anesthetic check up a day prior to surgery. Standard fasting guidelines (WHO) will be followed by all patients. In the operating room, standard monitoring will be done as per ASA recommendation. Patients will be placed in a supine position with their heads elevated approximately 15 degrees. Preoxygenation will be done with 100% oxygen for 3 minutes. General anesthesia will be administered to the patient as per the standard protocol of the institute. Once induced, according to the randomization and group assigned to the patient, the anesthetist will place a nasopharyngeal airway or nasal cannula or THRIVE on the patient.
Group P: will receive !00% oxygen @5L/min via nasopharyngeal airway
Group C : will receive 100% oxygen@5L/min via nasal cannula
Group H: will receive 100% oxygen @70L/min via THRIVE
SpO2 will be closely monitored. Timing will be terminated when the safe apnoea time of 8 minutes or if the SpO2 drops tp 95% at any time before 8 minutes.
Arterial blood gas analysis will be done at two separate times
-
After the induction of anesthesia
-
at the end of 8 minutes or when SpO2 drops to 95% whichever occurs earlier.
Maintenance and reversal of anesthesia will be as per standard protocol
Outcome parameters:
-
safe apnoea duration
-
Number of patients whose SpO2 dropped to or below 95%
-
PaO2 and PaCO2 immediately after induction of anesthesia and at the end of 8 minutes
-
SBP, DBP, MAP and HR every 30 seconds for 8 minutes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA PS I and II
- •Patients with normal cardiorespiratory function
- •Patients with thyromental distance more than 6cm
- •Patients with MMPG I,II and mouth opening more than 2.5cm
- •Patients with normal mask ventilation.
排除标准
- •Patients with
- •Anatomical abnormalities or a surgical history of the face, nose or upper airway
- •Nasal obstruction or difficult airway
- •Elevated intracranial pressure
- •Uncontrolled hypertension
- •BMI more than 30kg per m2
- •Refusal of consent.
结局指标
主要结局
To compare the effect of apnoeic oxygenation by nasopharyngeal airway vs nasal cannula vs THRIVE in prolonging the duration of apnoea
时间窗: 8 minutes
次要结局
- 1. To assess arterial oxygen partial pressures, arterial carbon dioxide partial pressure after the induction of anaesthesia and at the end of 8 minutes or when SpO2 drops to 95% whichever occurs earlier 2. To assess SBP, DBP, MAP and HR every 30 seconds(2 years)
研究者
Shrutijharna Das
AIIMS NEW DELHI