Assessment of Provider Position for Prehospital Tracheal Intubation

NCT07165314 | Completed

• 1 other identifier: Req-2025-01129
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Endotracheal intubation may be needed in critically ill patients in the prehospital setting, where difficult conditions may be encountered. The patient may be lying on the ground, thus complicating direct laryngoscopy as the operator's visual axis cannot be properly aligned with the patient's oral-pharyngeal-tracheal axis. The posture sitting cross-legged ("Lotus" position) at the head of the patient may allow an easier alignment of the visual axes due to a lower operator's head position and more stability. We compared the impact of the "Lotus" position with free positioning of the operator for direct laryngoscopy on intubation first pass success rate among novice operators.

Conditions

Tracheal Intubation

Keywords

advanced airway management; laryngoscopy; sitting position; prehospital; manikin; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• First Pass Success rate

  In percentage, defined as achieving successful ETI on the initial attempt. An ETI attempt was counted since the laryngoscope blade was inserted at the dental arch, regardless of whether tracheal tube placement was attempted or not. ETI was considered successful when adequate ventilation was confirmed by chest elevation. The number of intubation attempts were limited to three, with a time limit of 60 seconds allowed per attempt.

  Periprocedural

Secondary Outcomes (6)

• Time to Intubation

  Periprocedural

• Time to Intubation for the first intubation attempt alone

  Periprocedural

• Number of intubations attempts

  Periprocedural

• Cormack and Lehane (CL) score

  Periprocedural

• Percentage Of Glottis Opening (POGO) score

  Periprocedural

Study Arms (2)

Free positioning

ACTIVE COMPARATOR

Procedure: Free positioning

Sitting cross-legged ("Lotus" position)

EXPERIMENTAL

Procedure: Sitting cross-legged ("Lotus" position)

Interventions

Free positioning PROCEDURE

Participants are not given instructions on how to position for intubation using direct laryngoscopy.

Free positioning

Sitting cross-legged ("Lotus" position) PROCEDURE

Participants are requested to sit cross-legged for intubation using direct laryngoscopy.

Sitting cross-legged ("Lotus" position)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All resident doctors with 1 to 6 years of post-graduate experience working in the Emergency Department (ED) at Geneva University Hospitals (Hôpitaux Universitaires de Genève (HUG)) and penultimate year of medical school students (5th year) studying at University of Geneva Faculty of Medicine (UGFM) - Performed less than 10 ETIs prior to take part in the research

You may not qualify if:

• More than 6 years of post-graduate experience
• Performed more than 10 ETIs prior to take part in the research

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1205, Switzerland

Location

Study Officials

• Laurent SUPPAN, PD Dr

  University Hospital, Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: September 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CH (1)