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.
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.
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.
- Conditions
- Noninvasive 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 group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Study group | Active comparator | Not described Receives: Procedure: Gentle chest pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted26 Nov 2015 (estimated)
- Study start1 May 2017
- Primary completion19 Oct 2017
- Study completion19 Oct 2017
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 25749553Morgan 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Ability of Gentle Chest Pressure to Maintain Peripheral Oxygenation in Intubated Pediatric Patients
- ClinicalTrials.gov ID
- NCT02615834
- Acronym / sponsor ID
- Pro00060292
- Conditions
- Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Study group | Active comparator | Procedure: Gentle chest pressure |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentle chest pressureGentle pressure on the patient's right chest will be applied to achieve 12 breaths per minute. | Procedure or surgery | Study group |
Primary outcome
Time for SpO2 level to reach 90%
Time frame: Immediately following mechanical ventilation to 100% SpO2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 25749553Tsui 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.
- Background: PubMed 25936933Morgan 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.
Related trials for Noninvasive Ventilation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Validation of the Turkish Version of the S3-NIV Questionnaire
Respiratory Insufficiency, Chronic Respiratory Failure
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Not yet recruitingObservational study
Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.