NCT03319303

Brief Summary

During any general anaesthetic which involves muscle relaxation artificial breathing is required. This is most commonly provided by pushing air under pressure (positive pressure ventilation) into the lungs via a tube in the airway (the tracheal tube). It has been observed for many years that with this form of breathing the distribution of gas within the lungs differs from that seen during 'natural' breathing: more of the gas goes to the upper parts of the lung than lower parts. This change in how the gas is distributed can lead to problems with how well oxygen is taken up by blood and carbon dioxide removed from the body. Previous work using mathematical modelling has found that the position of the tracheal tube might affect air distribution, but this has previously been difficult to study in 'real life', requiring the use of radioactive dyes and computerised tomography (CT). However a bedside test is now available which allows us to study these changes rapidly and non-invasively, using electrical impedance tomography (EIT). The EIT device is commercially available (PulmoVista®, Draeger UK) and is used in hospitals worldwide as a bedside monitor of lung ventilation. This study aims to investigate the effect of tracheal intubation on regional ventilation of the lungs by comparing measurements before and after the patient is anaesthetised and intubated. The investgiators aim to show whether altered patterns of ventilation are caused by patients simply being asleep and ventilated, or whether these changes are due to the use of a tracheal tube itself. The exact effect of tube position will also be studied by measuring ventilation as the tube is deliberately advanced until it enters one of the lungs. This will give us information about the ideal position for a tube within the trachea to promote optimal ventilation patterns within the lungs

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

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

October 19, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

October 19, 2017

Last Update Submit

June 28, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Manipulation of the tracheal tube and deliberate insertion into a right or left main bronchus

    General anaesthesia will then be induced, and when the participant is asleep a further set of measurements will be taken using the Electrical impedance tomography (EIT) belt whilst ventilation is maintained using the normal bag-mask ventilation technique used by anaesthetists in the first few minutes of the anaesthetic. Following this, the trachea will be intubated by the anaesthetist clinically responsible for the patient, and a further set of EIT measurements taken.

    20 mins

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients attending for a surgical procedure are eligible and will be approached.

You may qualify if:

  • Willing and able to consent
  • undergoing a surgical procedure for which the anaesthetic technique includes muscle relaxation, intubation and ventilation for clinical care.

You may not qualify if:

  • Unwilling or unable to consent
  • co-existant respiratory disease associated with known abnormalities of ventilation/perfusion matching. This includes chronic obstructive pulmonary disease, asthma, or abnormalities of the chest wall or abdomen affecting ventilation e.g. morbid obesity
  • Requirement for double-lumen tracheal tube for clinical care
  • increased risk of regurgitation/aspiration e.g. pregnancy, symptomatic acid reflux, structural abnormalities of the gastro-intestinal tract (e.g. hiatus hernia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3HE,, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 24, 2017

Study Start

October 20, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations