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Noninvasive VentilationNCT02615834

Chest Pressure for Intubated Peds Patients

A study testing Gentle chest pressure in people with Noninvasive Ventilation, run by University of Alberta at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Noninvasive Ventilation
What is being tested?
Gentle chest pressure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
1 May 2017to 19 Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

About this study

Official title: Testing the Ability of Gentle Chest Pressure to Maintain Peripheral Oxygenation in Intubated Pediatric Patients

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.

Read the detailed description

BACKGROUND Airway management is different in the pediatric population compared to adults mainly due to the differences in respiratory physiology and anatomy. The oxygen consumption is about three times as high in children than in adults resulting in a higher impact on oxygen delivery and reserve should there be a problem with ventilation in children. During inspiration, the vertical dimension of the chest cavity is increased and the rib margins are lifted and moved out, causing an increase in the transverse diameter of the thorax. This generates a negative pressure in the intrapleural space between the lungs and the chest wall resulting in lung inflation. The rib cages of young children are very pliable. One of the theoretical ways to improve the efficiency of lung inflation in small children with such compliant rib cage is to apply pressure on the chest. The intrathoracic pressure increases above atmospheric pressure and air preferentially flows out of the lungs according to the pressure gradient. When the pressure on the chest is released and the thorax recoils passively ("springs open"), a negative intrathoracic pressure is generated. This effectively "sucks" air into the lungs along the pressure gradient. Although age-related pliability differences may be present, we do not expect this to be a significant factor in using the chest pressure technique successfully.

We previously demonstrated that application of gentle pressure on the right chest of pediatric patients generated 20% of the tidal volume achieved with mechanical ventilation, regardless of whether the patient was intubated or not. Chest pressure was monitored using a force transducer and did not exceed the patient's body weight. Indeed, the pressure used was considerably less than what would be administered during cardiopulmonary resuscitation. There was little variation across age ranges; for each age group, we observed a difference of less than 1 mL/kg compared to the overall mean tidal volume. Our study also showed that the gentle chest pressure technique was well-tolerated by pediatric patients of any age (neonate to adolescent), and no adverse events were encountered, supporting this technique as a very low-risk maneuver.

While these results are encouraging, the study did not provide detailed information on how much peripheral oxygenation (SpO2) is achieved with the gentle chest pressure technique. An editorial that accompanied the published study supports further investigation of the technique, including the extent to which it provides ventilation and its ability to provide adequate oxygenation. In this study, we wish to perform the technique on pediatric patients to determine if it can be used to maintain SpO2 for a significant length of time. For safety purposes, all trials will be done on patients whose tracheae have been intubated.

OBJECTIVE To determine if a gentle chest pressure technique can be used to maintain SpO2 over 90% significantly longer than allowing SpO2 to desaturate spontaneously.

HYPOTHESIS Gentle chest pressure can maintain SpO2 over 90% for significantly longer than if tissues are allowed to desaturate spontaneously.

METHODS After obtaining ethics approval, informed consent with or without assent whenever is appropriate (usually above the age of 6 years) will be obtained on the day ward. Consent will be obtained by a research assistant not involved with the clinical care of the patient. The demographic details of the patients, such as age, weight, height, ASA and any medical conditions will be recorded. The patient will be taken into the operating room, and routine monitoring will be applied. After induction of a standard general anesthesia where the technique is at the discretion of each individual anesthesiologist responsible for the case, the patient's trachea will be intubated. The patient will be ventilated mechanically for two minutes to achieve 100% peripheral oxygen saturation.

During this time, the patient will be randomly allocated to one of two groups - intervention and control - by a member of the study team. Instructions in sealed envelopes will indicate whether the chest pressure technique will be used or not. For patients in the intervention group, the anesthesiologist will apply gentle pressure (not exceeding the patient's own weight) vertically down on the patient's right chest. In the previous study, we calibrated pressure using a force transducer; since then, the Stollery pediatric anesthesia staff has been employing the technique in regular practice and are well experienced with the amount of force needed to generate adequate tidal volume. Since a pre-defined distance to depress the chest (e.g., 1 or 2 cm) is difficult to use for a wide range of patients weights (approximately 9-67 kg range in the previous study), in this study, the anesthesiologist will apply pressure to the point where resistance is encountered and then release. Upon release of pressure, the anesthesiologist will wait for one second. In our experience, the time taken to apply downward pressure and allow for chest recoil lasts approximately four seconds which, with the one second pause following pressure release, creates a total time of 5 seconds for the entire maneuver. As such, the maneuver can be used to achieve 12 breaths per minute. Oxygen saturation will be monitored and recorded continuously. The time taken for SpO2 levels to fall to 90% will be recorded, at which point, the anesthesiologist will restart mechanical ventilation. If SpO2 values fall below 90% at any time while the chest pressure technique is being performed, the patient can be ventilated mechanically immediately because they are already intubated.

Patients randomized to the control group will receive the same care as the intervention group except that no chest pressure technique will be performed. Following mechanical ventilation to 100% SpO2, surgery will proceed as normal with no additional intervention (i.e., gentle chest pressure) by the anesthesiologist. Peripheral oxygen saturations will be monitored during this time, and once the level reaches 90%, the time will be recorded, and the anesthesiologist will restart mechanical ventilation.

Being tested
Gentle chest pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gentle chest pressureProcedure or surgery

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

Study groups in NCT02615834
Study groupRoleWhat they receive
Control groupNo interventionNot described
Study groupActive comparatorNot described
Receives: Procedure: Gentle chest pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time for SpO2 level to reach 90%

    Measured: Immediately following mechanical ventilation to 100% SpO2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2015 (estimated)
  2. Study start1 May 2017
  3. Primary completion19 Oct 2017
  4. Study completion19 Oct 2017

Why it stopped: No participants enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02615834
Sponsor's protocol ID
Pro00060292
Status last verified
Mar 2020
First submitted
24 Nov 2015
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25749553
  • 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.

    PubMed 25936933

Questions about this trial

What is this clinical trial studying?

A study testing Gentle chest pressure in people with Noninvasive Ventilation, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time for SpO2 level to reach 90% (time frame: Immediately following mechanical ventilation to 100% SpO2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02615834, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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