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Clinical Trials/CTRI/2021/04/033106
CTRI/2021/04/033106CompletedNot Applicable

A prospective randomized control study to compare the efficacy of “Between the fingers Grip†with conventional “Pen holding Grip†to hold an endotracheal tube for orotracheal intubation

SGPGIMS1 site in 1 country100 target enrollmentStarted: January 5, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
SGPGIMS
Enrollment
100
Locations
1
Primary Endpoint
To compare the success rates of the modified grip with the control group (standard grip) in terms of number of attempts (upto two) and then requirement of assistance or aids to perform endotracheal intubation.

Study Overview

Brief Summary

Endotracheal intubation provides the most secure airway and its execution depends upon the assessment of airway and accurate laryngoscopy. This relies upon the use of different types of laryngoscopes, endotracheal tubes, and external aids. |The current literature has focused on the above mentioned in detail, still, there is a lack of evidence on the method of holding the endotracheal tube to facilitate orotracheal intubation. Therefore, in this study, we will assess the utility of using the modified method, which is ’between the fingers’ grip to hold the endotracheal tube over the conventional ’pen holding grip’. We presume the former will provide us control for maneuvering the tip of endotracheal tube anteriorly, thus helping in endotracheal intubation. This will be a prospective, randomized control study to compare the success rates of modified grip with the control group (standard grip) in terms of number of attempts and the requirement of assisstance to perform endotracheal intubation. 50 patients, after computer generated randomization, will be recruited in each group. Patients willing to participate, with airway assessment Cormack Lehane grade 1/ 2a/ 2b/ 3a, who are 18-60 years of age and are undergoing intubation by an experienced anaesthesiologist will be included in the study. Patients with an anticipated difficult airway, head and neck pathologies, history of difficult intubation and Cormack Lehane grade 3b and 4 will be excluded from the study. Written and informed consent will be obtained from all the patients fulfillingthe inclusion criteria by explaining the details of the study in their language in presence of a witness. On arrival in the operating room, anaesthetic induction will be done as per standard protocol and the patient will be positioned for endotracheal intubation. This is followed by laryngoscopy using a Macintosh blade (size 3 and 4). Laryngoscopy will be done by an anaesthesiologist with at least 3 years experience in clinical anaesthesia. The CL grading will be noted. A standard oral cuffed tracheal tube will be used according to the patient profile. Orotracheal intubation will be performed after visualizing the glottis. The conventional or modified grip of holding the endotracheal tube will be applied to the patient according to their assigned group according to the randomization table, and observation will be noted. The assessment of each method will be done based on the following criteria, whether it was an unaided single or double attempt intubation, how much time was taken after visualization of Laryngeal inlet till 1st value of EtCO2, whether stylet of bougie was required, whether BURP was required to aid the intubation andcomparing the hemodynamic parameters during the application of each method

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients willing to participate
  • Intubation by experienced Anaesthesiologist.

Exclusion Criteria

  • CL grade 3b/4
  • Patients with anticipated difficult airway
  • Patients with pasthistory of difficult intubation
  • Patients who previously underwent tracheostomy
  • Patients with restricted neck movement.

Outcomes

Primary Outcomes

To compare the success rates of the modified grip with the control group (standard grip) in terms of number of attempts (upto two) and then requirement of assistance or aids to perform endotracheal intubation.

Time Frame: Assessment done only once.(Ist time point)after Anaesthetic induction during laryngoscopy and endotracheal intubation

Secondary Outcomes

  • 1) To calculate the time required in each grip [From introduction of ETT into mouth to 1st EtCO2 graph reading](2) To compare the hemodynamic parameters (HR and BP) in two groups [from laryngoscopy till 5 min after intubation])

Investigators

Sponsor
SGPGIMS
Sponsor Class
Research institution and hospital

Study Sites (1)

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