Head Positions to Open the Airway IV

Head Positions to Open the Upper Airway IV

After routine induction of general anaesthesia peak airway pressure (= P max) and other respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and without head support in three different head positions: neutral position, reclination of the head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on different head positions;

Study Overview

• Status: Completed
• Conditions: Cardiac or Respiratory Arrest, Anaesthesia
• Intervention / Treatment: Procedure: head extension; Procedure: neutral position; Procedure: anaesthesiologist´s position

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Klinik für Anästhesie und Allgemeine Intensivmedizin, Medizinische Universität Innsbruck, Anichstraße 35

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male and female patients ≥ 18 years
• elective operations in general anaesthesia
• patient´s written informed consent
• American Society of Anesthesiology scale I-III

Exclusion Criteria:

• non fasting patient
• body mass index > 35 kg/m2
• anamnestic cervical spine pathologies or other peripheral neurological deficiences due to pathologies of the cervical spine
• malformations of the head or upper airway
• history of perforation of stomach or esophagus
• anamnestic hiatus hernia or reflux
• acute respiratory infection or obstructive airway disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: with head support; patients are ventilated with their heads positioned on a support	Procedure: head extension; the lungs are ventilated with the patient´s head extended; Procedure: neutral position; the lungs are ventilated with the patient´s head in neutral position; Procedure: anaesthesiologist´s position; the lungs are ventilated with the patient´s head positioned deemed ideal by the anaesthesiologist
Sham Comparator: without head support; patients are ventilated without head support	Procedure: head extension; the lungs are ventilated with the patient´s head extended; Procedure: neutral position; the lungs are ventilated with the patient´s head in neutral position; Procedure: anaesthesiologist´s position; the lungs are ventilated with the patient´s head positioned deemed ideal by the anaesthesiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak airway pressure	peak airway pressure is measured over one minute

Collaborators and Investigators

• Sponsor: Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: anesthesia, cardiac arrest, resuscitation, ventilation
• Other Study ID Numbers: UN5155 327/4.10