NCT01394172

Brief Summary

The purpose of this study is to quantify the tidal volume generated by the pressure release immediately following the application of pressure to the chest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

2.9 years

First QC Date

July 6, 2011

Last Update Submit

August 11, 2015

Conditions

Apnea

Keywords

Tidal VolumePediatricDifficult airwayVentilationAirway management

Outcome Measures

Primary Outcomes (1)

  • Tidal volume (mL), as displayed by the Draeger Narkomed 6400 Anesthesia Machine, after release of manual chest compression

    One tidal volume is displayed on the Draeger machine immediately after the manual release of chest compression. This outcome is recorded 3 times in each patient after fast manual compressions (1-2 seconds each), with the process performed while the patient is both bag-mask ventilated and intubated.

    After induction of general anesthesia and until completion of surgery (within an average time of 30 mins to 4 hours)

Secondary Outcomes (1)

  • Force of compression (kg), as displayed by the Lafayette Manual Muscle Tester, measured during each manual chest compression

    after induction of general anesthesia and during surgery (between 30 mins and 4 hours)

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This is a prospective, cohort study with a sample size of approximately 100 pediatric patients. The population will be stratified equally into the following age groups: neonate (0-28 days or 44 post-conceptual weeks), infants (\>1-12 months), toddlers (\>12months-3 years), children (\>3-8 years), pre-teen (\>8-13 years) and adolescent (\>13 years).

You may qualify if:

  • All pediatric patients under the age of 18 years old.
  • All patients requiring a general anesthetic with an endotracheal tube (whether the patient will be intubated with an endotracheal tube will be decided by the anesthesiologist responsible for the case)
  • ASA (American Society of Anesthesiologists Physical Status Classification) I to III

You may not qualify if:

  • Failure to obtain parental consent or patient assent when appropriate (in general children over 8 years old)
  • ASA (American Society of Anesthesiologists Physical Status Classification) IV
  • Patients with any cardiac pathology
  • Patients with any respiratory pathology
  • Patients with any form of chest deformity (examples being pectus excavatum, pectus carinatum, scoliosis)
  • Patients who had previous cardiac/thoracic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (4)

  • Williams AJ. ABC of oxygen: assessing and interpreting arterial blood gases and acid-base balance. BMJ. 1998 Oct 31;317(7167):1213-6. doi: 10.1136/bmj.317.7167.1213. No abstract available.

    PMID: 9794863BACKGROUND

  • Adler SM, Wohl ME. Flow-volume relationship at low lung volumes in healthy term newborn infants. Pediatrics. 1978 Apr;61(4):636-40.

    PMID: 662489BACKGROUND

  • Braga MS, Dominguez TE, Pollock AN, Niles D, Meyer A, Myklebust H, Nysaether J, Nadkarni V. Estimation of optimal CPR chest compression depth in children by using computer tomography. Pediatrics. 2009 Jul;124(1):e69-74. doi: 10.1542/peds.2009-0153.

    PMID: 19564271BACKGROUND

  • Tsui BC, Horne S, Tsui J, Corry GN. Generation of tidal volume via gentle chest pressure in children over one year old. Resuscitation. 2015 Jul;92:148-53. doi: 10.1016/j.resuscitation.2015.02.021. Epub 2015 Mar 4.

    PMID: 25749553DERIVED

MeSH Terms

Conditions

ApneaRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Ban Tsui, M.D., M.Sc.

    Department of Anesthesiology and Pain Medicine, University of Alberta

    PRINCIPAL INVESTIGATOR

  • Viv Ip, M.D.

    Department of Anesthesiology and Pain Medicine University of Alberta

    STUDY DIRECTOR

  • Sara Horne, B.Sc.(Hons)

    Department of Anesthesiology and Pain Medicine University of Alberta

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 14, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2014

Study Completion

February 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

CA(1)