A prospective study to compare the intubating conditions of cuff Inflation technique versus magills Forceps technique for nasotracheal intubation under direct Laryngoscopy 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
- 80
- 试验地点
- 1
- 主要终点
- This prospective and observational study will help us to compare the intubating conditions of cuff inflation technique versus magills forceps technique for nasotracheal intubation under direct laryngoscopy in adult patients undergoing surgery under general anaesthesia and will enable us to understand which technique is a superior ,hemodynamically stable and requires less duration, attempts for successful nasotracheal intubation and also have less incidence of complications
研究概览
简要总结
A prospective study to compare the Intubating conditions of cuff Inflation technique versus magills Forceps technique for nasotracheal Intubation under direct Laryngoscopy in adult patients
AIM
To compare the intubating conditions of cuff inflation technique versus magills forceps technique for nasotracheal intubation under direct laryngoscopy in adult patients
The objectives are :
-
To compare total duration for nasotracheal intubation with direct laryngoscopy by using cuff inflation technique versus magills forceps technique.
-
To compare stress response changes during the procedure 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 equal to 3cm
6. Patient with Malampatti grade 1 , 2
Exclusion Criteria :
1. Patients unwilling to participate in the study.
2. Patients belonging to American Society of Anaesthesiologists (ASA) physical status III & 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 & 4
Methods:
This Randomized Prospective Observational Study will be conducted in Department of Anaesthesiology in Dhiraj hospital. After approval from institutional ethical committee the study will be conducted to compare the intubating conditions of cuff inflation technique versus magills forceps technique for nasotracheal intubation under direct laryngoscopy on 66 adult patients including both genders, aged between 18 to 60 years.
Patients will be randomly allocated using computer generated random numbers into two groups: Group C and Group M of 40 patients each.
Group C (n= 40) Patients will be intubated nasotracheally using direct laryngoscope with Cuff inflation technique
Group M (n= 40 ) Patients will be intubated nasotracheally using direct laryngoscope with Magills forceps technique
The procedure will be performed by the anaesthesiologist not related to study. All the patients will be explained clearly about the purpose and nature ofthe Study in the language they can understand. They will be included in the study only after obtaining a Written informed consent
Study site: Dhiraj hospital, S.B.K.S. Medical institute and research center, Sumandeep vidyapeeth deemed to be university, piparia, vadodara,Gujarat.
Study design: Randomized Prospective Observational Study
Likely Outcome of the study :
This prospective and observational study will help us to compare the intubating conditions of cuff inflation technique versus magills forceps technique for nasotracheal intubation under direct laryngoscopy in adult 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
- •Patients willing to sign informed consent.
- •Male or female patients between ages of 18 to 60 years.
- •Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II
- •Patient having mouth opening equal to 3cm
- •Patient with Malampatti grade 1 , 2.
排除标准
- •Patients unwilling to participate in the study.
- •Patients belonging to American Society of Anaesthesiologists (ASA) physical status III & 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 & 4.
结局指标
主要结局
This prospective and observational study will help us to compare the intubating conditions of cuff inflation technique versus magills forceps technique for nasotracheal intubation under direct laryngoscopy in adult patients undergoing surgery under general anaesthesia and will enable us to understand which technique is a superior ,hemodynamically stable and requires less duration, attempts for successful nasotracheal intubation and also have less incidence of complications
时间窗: The haemodynamic parameters including the heart rate (HR), oxygen Saturation (SpO2),systolic blood pressure (SBP), diastolic blood pressure (DBP) will be noted at the baseline, after intubation and at 1,3, 5, 7 and 10 min after intubation. Also other parameters will be noted like Time taken for intubation, Cormack-Lehane grading grading, the total numbers of attempts,use assistance like external laryngeal manipulation (ELM).
次要结局
- To understand which laryngoscopy with cuffinflation technique have less incidence ofcomplications like Sore throat(Post operative complications like Nasal/oralbleeding ,)
研究者
Dhananjay Nivrutti Dhasade
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre