Chest Pressure for Intubated Peds Patients

NCT02615834 | Withdrawn

• 1 other identifier: Pro00060292
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

We previously showed that a gentle chest pressure technique could be used on children over a year old to generate around 20% of the volume of air inhaled or exhaled in a single normal breath (also known as tidal volume). This showed that a non-invasive method could be used to provide a temporary means of artificial breathing, meaning that invasive procedures, such as putting in a breathing tube, could be avoided. What our results did not tell us, however, is how much oxygen can get to peripheral tissues (e.g., arms, legs) with this method. In this study, we want to compare two groups of children. All children will have a breathing tube; one group will have gentle chest pressure performed on them to see if oxygen saturations can be maintained above 90%. The other group will receive no chest pressure. We will see how long it takes for oxygen levels in both groups to drop to 90%, at which point, the patient will be ventilated mechanically.

Conditions

Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Time for SpO2 level to reach 90%

  Immediately following mechanical ventilation to 100% SpO2

Study Arms (2)

Control group

NO INTERVENTION

Study group

ACTIVE COMPARATOR

Procedure: Gentle chest pressure

Interventions

Gentle chest pressure PROCEDURE

Gentle pressure on the patient's right chest will be applied to achieve 12 breaths per minute.

Study group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All pediatric patients between one and 18 year of age
• Requirement for insertion of an endotracheal tube
• American Society of Anesthesiologists (ASA) class I to III

You may not qualify if:

• Failure to obtain parental consent or patient assent when appropriate (in general, children over 6 years of age)
• ASA IV
• Patients with any cardiac pathology
• Patients with any respiratory pathology
• Patients with any form of chest deformity, for example, pectus excavatum, pectus carinatum, scoliosis
• Patients who had previous cardiac or thoracic surgery

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (2)

• 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: 25749553 BACKGROUND

• Morgan RW, Nadkarni VM, Berg RA. Can gentle chest compressions result in substantial ventilation? Resuscitation. 2015 Jul;92:A2-3. doi: 10.1016/j.resuscitation.2015.04.003. Epub 2015 Apr 29. No abstract available.

  PMID: 25936933 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: May 1, 2017
• Primary Completion: October 19, 2017
• Study Completion: October 19, 2017
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CA (1)