A pilot study assessing the Cook Staged Extubation Set for endotracheal tube insertion in simulated difficult airway in patients undergoing routine intubation for elective surgery

Not Applicable

Recruiting

• Conditions: General Anaesthesia; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12615000452594
• Lead Sponsor: The Townsville Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Adults
Elective surgical patients requiring intubation

Exclusion Criteria

1.American Society of Anaesthesiologists (ASA”) physical status classification >2
2.Body Mass Index (BMI”) >35
3.Previously recorded Cormack and Lehane (C&L”) classification > grade 2 laryngeal view
4.Previously recorded need to use an accessory device to accomplish tracheal intubation, eg. Frova Airway Intubating Catheter or Gum Elastic Bougie
5.Any disease or condition that may significantly reduce the time between the onset of apnoea and arterial haemoglobin oxygen desaturation
6.Any condition or morphological feature that may compromise face mask ventilation
7.Planned rapid sequence intubation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful intubation[Within 60 seconds from second face mask removal.]

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale of procedural difficulty[Completed by intubator after intubation is completed, tube is secured, and they are free from other immediate practical tasks related to the case. Likely to be within 10 minutes of completing the intubation procedure.];Time to appearance of capnography trace.[Within 60 seconds from second face mask removal.];Modified intubation difficulty score[Completed by intubator after intubation is completed, tube is secured, and they are free from other immediate practical tasks related to the case. Likely to be within 10 minutes of completing the intubation procedure.];Other comments. In addition to the structured assessment of the device in outcomes 2 and 3, the intubator will be asked whether they would like to offer any additional remarks about the use of the device.[After intubation is completed, tube is secured, and the intubator is free from other immediate practical tasks related to the case. Likely to be within 10 minutes of completing the intubation procedure.]