A prospective study to compare the intubation conditions for nasotracheal intubation with standard direct macintosh laryngoscope versus BPL video laryngoscope using cuff inflation technique in adult patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- This prospective study will enable us to understand which laryngoscopy is superior , hemodynamically stable and total duration for intubation , attempts for successful intubation and also have less incidence of complications.
研究概览
简要总结
Randomized prospective study will be conducted in department of Anaesthesiology in Dhiraj hospital after approval from institutional ethical committee and written informed consent.
Aim
To compare the inubating conditions for nasotracheal intubation with standard direct Macintosh laryngoscope versus BPL Video laryngoscope using cuff inflation technique in adult patients.
The objectives are :
-
To compare total duration for nasotracheal intubation with macintosh laryngoscope versus video laryngoscope by cuff inflation technique.
-
To compare hemodynamic changes during the procedure between two groups
-
To compare the need for assistance with magills forceps, external laryngeal maneuvers for nasotracheal Intubation between two groups
-
To compare total number of attempts required for successful nasotracheal intubation between two groups
-
To compare complications if any between two groups.
INCLUSION CRITERIA**:**
1. Patients willing to sign informed consent.
2. Male or female patients between ages of 18 to 60 years.
3. Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II.
4. Patients posted for elective surgeries requiring nasal intubation under general anaesthesia.
5. Patient having mouth opening more than 3cm
6. Patient with Malampatti grade 1 and 2
EXCLUSION CRITERIA:
1. Patients unwilling to participate in the study.
2. Patients belonging to American Society of Anaesthesiologists (ASA) physical status III and IV
3. Patients having contraindication to nasal intubation. Eg. nasal polyps,nasal bone fracture,mass in nasal cavity.
4. Patient having mouth opening less than 3cm.
5. Patient with Mallampati grade 3 and 4
Methods:
66 adult patients fulfilling the criteria including both genders, aged between 18 to 60 years will be randomly allocated using computer generated random numbers into two groups: Group V and Group M of
33 patients each.
Group V(n= 33) Patients were intubated nasotracheally using non-channelled blade of BPL Video laryngoscope with cuff inflation technique
Group M (n= 33 ) patients were intubated nasotracheally using Macintosh laryngoscope with cuff inflation technique
The procedure will be performed by the anaesthesiologist not related to study.
Likely outcome of the study:
This prospective study will help us to compare the intubating conditions for Nasotracheal intubation (NTI) with standard direct Macintosh laryngoscope versus BPL video laryngoscope using cuff inflation technique in patients undergoing surgery under general anaesthesia and will enable us to know which of the two technique is most beneficial in performing Nasotracheal Intubation by having better outcomes in hemodynamics with minimal complications.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to sign informed consent.
- •2.Male or female patients between ages of 18 to 60 years.
- •3.Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II.
- •Patients posted for elective surgeries requiring nasal intubation under general anaesthesia.
- •Patient having mouth opening more than 3cm
- •Patient with Malampatti grade 1 and 2.
排除标准
- •Patients unwilling to participate in the study.
- •Patients belonging to American Society of Anaesthesiologists (ASA) physical status III and IV
- •Patients having contraindication to nasal intubation.
- •Eg. nasal polyps,nasal bone fracture,mass in nasal cavity.
- •Patient having mouth opening less than 3cm.
- •Patient with Mallampati grade 3 and 4.
结局指标
主要结局
This prospective study will enable us to understand which laryngoscopy is superior , hemodynamically stable and total duration for intubation , attempts for successful intubation and also have less incidence of complications.
时间窗: T1 (seconds) time taken for ETT introduction from selected nostril to oropharynx ,T2 (seconds) for laryngoscopy till passage of ETT into the vocal cords is noted. Heart rate (HR), oxygen Saturation (SpO2),systolic blood pressure (SBP), diastolic blood pressure (DBP) will be noted at baseline, after intubation ,at 1,3, 5, 7 and 10 minutes after intubation. Cormack-Lehane grading grading, numbers of attempts,assistance like external laryngeal manipulation (ELM) or Magill forceps will be noted
次要结局
- To understand which laryngoscopy with cuff inflation technique have less incidence of complications like Sore throat(Post operative complications like Nasal/oral bleeding ,)
研究者
Dhananjay Nivrutti Dhasade
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre