NCT01909310

Brief Summary

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;

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

July 24, 2013

Last Update Submit

March 21, 2017

Conditions

Cardiac or Respiratory Arrest, Anaesthesia

Keywords

anesthesia, cardiac arrest, resuscitation, ventilation

Outcome Measures

Primary Outcomes (1)

  • Peak airway pressure

    peak airway pressure is measured over one minute

Study Arms (2)

with head support

ACTIVE COMPARATOR

patients are ventilated with their heads positioned on a support

Procedure: head extensionProcedure: neutral positionProcedure: anaesthesiologist´s position

without head support

SHAM COMPARATOR

patients are ventilated without head support

Procedure: head extensionProcedure: neutral positionProcedure: anaesthesiologist´s position

Interventions

head extensionPROCEDURE

the lungs are ventilated with the patient´s head extended

with head supportwithout head support
neutral positionPROCEDURE

the lungs are ventilated with the patient´s head in neutral position

with head supportwithout head support
anaesthesiologist´s positionPROCEDURE

the lungs are ventilated with the patient´s head positioned deemed ideal by the anaesthesiologist

with head supportwithout head support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

ApneaHeart ArrestRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Peter Paal, EDAIC, EDIC

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 26, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2015

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations

AU(1)