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This study is about finding a better way for doctors to place a breathing tube into a patients windpipe during surgery. This tube helps the patient breathe safely while they are under anaesthesia. The study will compare how often the tube is placed successfully on the first try

Comparative Study between Traditional Pen Holding Technique and Between-the-Fingers Grip Technique for Endotracheal Tube Handling during Orotracheal Intubation: A Randomised controlled trial - nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113650
Enrollment
112
Registered
2026-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B961- Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere

Interventions

Intervention1: Between-the-Fingers Grip technique of Orotracheal Intubation.: Patient will be intubated by Between-the-fingers grip technique in group B. Another experienced anaesthesiologist will be

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age 18 to60 years This range includes adult patients with relatively predictable airway anatomy and physiological responses. Extremes of age paediatric and elderly populations are associated with anatomical and physiological variations that could independently influence intubation difficulty and haemodynamic responses. 2.ASA physical status I to III Including patients with mild to moderate systemic disease ensures generalizability while maintaining safety. Higher ASA grades IV and above are more likely to have unstable physiology, which could confound haemodynamic outcomes and increase procedural risk. 3 Elective surgery under general anaesthesia requiring endotracheal intubation . Elective settings allow adequate preoperative airway assessment and standardization of conditions. This reduces variability compared to emergency situations. 4 Mallampati grades I to III These grades encompass easy to moderately difficult airways. Including this range allows evaluation of both techniques across a spectrum of common airway scenarios while avoiding extreme difficulty. 5.Cormack Lehane grades I IIa IIb and IIIa These laryngoscopic views represent varying degrees of glottic visualization that are still manageable with standard techniques. Including them ensures that the techniques are tested in realistic clinical conditions without introducing extreme airway difficulty that may require alternative strategies.

Exclusion criteria

Exclusion criteria: 1 Refusal to participate Ethical research mandates voluntary informed consent. 2 Anticipated difficult airway like Mallampati grade IV mouth opening less than 3 cm, thyromental distance less than 6 cm .These predictors are associated with high intubation difficulty and may necessitate advanced airway devices or techniques, which would confound comparison between the two grip methods. 3 History of difficult airway Previous documentation suggests increased unpredictability and risk, which could bias outcomes and compromise safety. 4 Head and neck pathology Structural abnormalities like tumors, trauma, deformities can significantly alter airway anatomy and make intubation technique-dependent comparisons unreliable. 5 Haemodynamic instability Since one of the study outcomes may involve haemodynamic responses, unstable patients could introduce significant variability unrelated to the technique used. 6 Emergency surgery Emergency cases often lack proper fasting status, airway evaluation, and preparation time, leading to uncontrolled variables and increased risk. 7 Pregnancy Pregnant patients have altered airway anatomy eg airway edema, increased aspiration risk, and different physiological responses, which could confound results and raise ethical concerns.

Design outcomes

Primary

MeasureTime frame
To compare the number of intubation attempts first-pass success and requirement of backward upward rightward pressure manuever BURP between the fingers grip with the traditional pen holding method of handling endotracheal tube. Timepoint: During the endotracheal intubation and immediately after intubation

Secondary

MeasureTime frame
1 To compare the time taken for successful endotracheal intubation for each grip & the haemodynamic parameters heart rate & mean arterial pressure between the two groups 2 To assess & compare post operative complications such as airway trauma sore throat between the two groups Timepoint: 1 Time taken will be noted immediately after orotracheal intubation 2 Haemodynamics will be noted at baseline at the time of intubation & immediately after intubation 3 Postoperative complications will be measured after the surgery

Countries

India

Contacts

Public ContactDr Praneshwori Sinam

North Eastern Indira Gandhi Regional Institute of Hospital and Medical Sciences, Shillong

praneshworisinam27@gmail.com7005217102

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026