Gastric InsufflationNCT01652924
Efficacy of Mechanical Ventilation With Facial Mask to Reduce Gastric Insufflation
A study testing Mechanical ventilation with facial mask and Manual ventilation with facial mask in people with Gastric Insufflation, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
The purpose of this study is to determine whether mechanical ventilation with facial mask during induction anesthesia in the population of 1month to 14years is associated with less risk of gastric insufflations as compared with manual ventilation. Read more about this study
- Who is it for?
- Ages 1 month to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Insufflation
- What is being tested?
- Mechanical ventilation with facial mask and Manual ventilation with facial mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteColombia
- Study dates
- May 2012to Aug 2012
- 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 month to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA I and III children, 1 month-14 years of age
- Children scheduled for surgery or therapeutic procedures under general anesthesia and fasting as defined in the fasting guidelines.
- Responsible adult patients whose accept and sign the informed consent of study.
Who cannot join
- Patients with limited mouth opening or cervical spine extension and classified as difficult airway
- Respiratory diseases
- Children with orogastric or nasogastric tubes
- Children with gastrostomies
- Patients with pulmonary aspiration risk: morbid obesity, intestinal obstruction, gastrointestinal bleeding, gastroparesis, gastroesophageal reflux.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
San Vincent Foundation, San Vincent Hospital
Medellín, Antioquia, 05001000
Olga Lucia Giraldo, MD, 574 2637900, olgiraldos@une.net.co
Olga Lucia Giraldo, MD
About this study
Official title: Efficacy and Safety of Pressure-controlled Ventilation Compared With Manual Ventilation to Reduce Gastric Insufflation During Induction of Anesthesia in Children: Controlled Trial Randomized, Double-blind
The purpose of this study is to determine whether mechanical ventilation with facial mask during induction anesthesia in the population of 1month to 14years is associated with less risk of gastric insufflations as compared with manual ventilation.
Read the detailed description
Manual ventilation is the most widely used during induction of anesthesia because of unsupported theoretical advantages in clinical trials as a test of airway patency and adequate ventilation and lung expansion. Additionally, in developing countries until recently lacked sufficient ventilation from supplying controlled fans with different modes that could be used during induction of anesthesia. However, case reports in pediatric and adult patients not intubated, note that manual ventilation could be related to increased frequency of gastric insufflation and predispose to regurgitation and aspiration, impaired ventilation, respiratory failure, reduced cardiac output and rupture or visceral ischemia. To date, no controlled clinical trials have to corroborate or not these experiences.
Gastric insufflation may appear as a result of manual ventilation or mechanical. In connection with the first because it does not allow volume control currents, the time of insufflation or inspiratory pressures, which determine the maximum peak inspiratory pressure, which is directly proportional to the incidence of this complication. Meanwhile, mechanical ventilation is associated with gastric insufflation when pressures exceed certain limits peak airway. vonGoedecke et al, in a clinical trial of mechanical ventilation (pressure control) against the manual in healthy adults during induction of anesthesia and whose outcome was ventilatory variables, they found that mechanical ventilation was associated with lower peak inspiratory pressures lower airway and peak inspiratory flow rates and tidal volumes and minute lower. They recommend mechanical ventilation during induction of anesthesia as the safe technique.
To make ventilation safer in an unprotected airway, can be considered two strategies: limiting the tidal volume or peak inspiratory pressure limit. Seet and colleagues compared in healthy adults two mechanical ventilation strategies in addition to the manual technique during induction considering a composite endpoint of ventilatory variables and gastric insufflation in a clinical trial. They found that pressure-controlled ventilation was associated with lower peak inspiratory pressure and gastric insufflation less than the other two methods, which suggest that this technique is safer and should be the method of choice for ventilation during apnea patients induction.
Several studies have shown the clinical significance of gastric insufflation during induction of anesthesia in 2009, Paal and colleagues presented the results of two studies in animals: one with them in cardiac arrest and another spontaneous circulation, in the first there was a abdominal compartment syndrome leading to hemodynamic compromise, respiratory, metabolic, and finally multi-organ, in animals with spontaneous circulation, the effects were even worse because there was a reduction in survival and in some gastric insufflation was considered as the cause of heart failure . The authors conclude that gastric insufflation alone can cause heart failure and multiple organ failure occurs much faster the more critical is the patient. , In addition to substantial mechanical cardiopulmonary effects, insufflation of the stomach is a complex problem that can cause regurgitation, aspiration, pneumonia and death. Increases abdominal pressure, elevates the diaphragm, restricts lung movement and thus reduce the compliance of the respiratory system. A reduction in respiratory system compliance may direct further ventilation volume into the stomach when the airway is not protected, thus inducing a vicious circle with each breath, increasing the insufflation of the stomach and decreasing lung ventilation. Added to this the fact that the anesthetic drugs reduce the lower esophageal sphincter pressure and more than 90% of cases in children suction produced in the induction of anesthesia, needless to emphasize the importance of controlling this adverse effect. Control of gastric insufflation by the above would be particularly useful in patients with comorbidities that predispose to regurgitation or cardiac arrest patients.
Children are at greater risk of gastric insufflation during induction of anesthesia because of anatomical and physiological characteristics inherent in the conduct of the respiratory system that promote airway obstruction and the passage of air into the stomach: proportional size of the head and tongue, short neck, small chin, among others. This is compounded by the use of a ventilation without control of parameters such tidal volume, inspiratory time and peak inspiratory pressure, as well as reduction of the lower esophageal sphincter pressure caused by anesthetics and airway devices. It is likely that this increased risk of gastric insufflation is the explanation for the increased incidence of aspiration and respiratory complications found in some studies, particularly during anesthetic induction.
The work of von GoedeckeSeet and are pioneers in this new form of induction of anesthesia with ventilation for the patient safer and more comfortable for the anesthesiologist, using more developed fans that bring new anesthesia machines and allow to get the most out of ventilatory modes that are built. However, lacking adequate methodological designs jobs to validate these techniques in different populations, and one of them is the pediatric population, the characteristics mentioned above would suggest that one of the most favored by this method. Therefore, this paper seeks to establish whether the pressure-controlled ventilation during induction of anesthesia reduces the incidence of gastric insufflation compared with manual ventilation of children aged 1 month to 14 years.
- Conditions
- Gastric Insufflation
- Being tested
- Mechanical ventilation with facial mask, Manual ventilation with facial mask
- Keywords
- mechanical ventilation, manual ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilation with facial maskDevice
Also called Mechanical ventilation during anesthetic induction
This group includes patients with the randomization process are assigned to mechanical ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation. The size of the facial mask is used according to the age and ventilation parameters are: inspiratory pressure 10 cmH2O, PEEP 5 cmH2O, respiratory frequency and relation I/E according to age .
Manual ventilation with facial maskDevice
Also called Manual ventilation during anesthetic induction
This group includes patients with the randomization process are allocated to manual ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation.
The size of the facial mask is used according to the age and ventilator y parameters are selected by the anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical ventilation | Experimental | 1: Active Comparator Children 1 month-14 years of age Intervention:Mechanical ventilation with facial mask during anesthetic induction Receives: Device: Mechanical ventilation with facial mask |
| Manual ventilation | Active comparator | 2: Active Comparator Children 1 month-14 years of age Intervention: Manual ventilation with facial mask during anesthetic induction Receives: Device: Manual ventilation with facial mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric insufflation determined by continuous epigastric auscultation until to secure the airway.
Intervention end up once the anesthesiologist to secure airway patient and during this time the investigator will auscultate the epigastrium
Measured: From anesthetic induction until to secure airway with endotracheal tube, an expected average of 5 minutes
Secondary outcomes (1)
Gastric insufflation determined by aspiration with orogastric tube after to secure the airway
Intervention end up once the anesthesiologist to secure airway patient and complete aspiration with orogastric tube.
Measured: First 3 minutes after to secure airway with endotracheal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric InsufflationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Luci-a Giraldo Salazar, Universidad de Antioquia
- Investigators
- Olga Lucia Giraldo, MD, Principal investigator, Antioquia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652924
- Sponsor's protocol ID
- Anestesia002
- Status last verified
- Jul 2012
- First submitted
- 24 Jul 2012
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pressure-controlled Ventilation Compared With Manual Ventilation to Reduce Gastric Insufflation During Induction of Anesthesia in Children: Controlled Trial Randomized, Double-blind
- ClinicalTrials.gov ID
- NCT01652924
- Acronym / sponsor ID
- Anestesia002
- Conditions
- Gastric Insufflation
- Keywords
- mechanical ventilation, manual ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 30 Jul 2012 (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.
The purpose of this study is to determine whether mechanical ventilation with facial mask during induction anesthesia in the population of 1month to 14years is associated with less risk of gastric insufflations as compared with manual ventilation.
Detailed description
Manual ventilation is the most widely used during induction of anesthesia because of unsupported theoretical advantages in clinical trials as a test of airway patency and adequate ventilation and lung expansion. Additionally, in developing countries until recently lacked sufficient ventilation from supplying controlled fans with different modes that could be used during induction of anesthesia. However, case reports in pediatric and adult patients not intubated, note that manual ventilation could be related to increased frequency of gastric insufflation and predispose to regurgitation and aspiration, impaired ventilation, respiratory failure, reduced cardiac output and rupture or visceral ischemia. To date, no controlled clinical trials have to corroborate or not these experiences.
Gastric insufflation may appear as a result of manual ventilation or mechanical. In connection with the first because it does not allow volume control currents, the time of insufflation or inspiratory pressures, which determine the maximum peak inspiratory pressure, which is directly proportional to the incidence of this complication. Meanwhile, mechanical ventilation is associated with gastric insufflation when pressures exceed certain limits peak airway. vonGoedecke et al, in a clinical trial of mechanical ventilation (pressure control) against the manual in healthy adults during induction of anesthesia and whose outcome was ventilatory variables, they found that mechanical ventilation was associated with lower peak inspiratory pressures lower airway and peak inspiratory flow rates and tidal volumes and minute lower. They recommend mechanical ventilation during induction of anesthesia as the safe technique.
To make ventilation safer in an unprotected airway, can be considered two strategies: limiting the tidal volume or peak inspiratory pressure limit. Seet and colleagues compared in healthy adults two mechanical ventilation strategies in addition to the manual technique during induction considering a composite endpoint of ventilatory variables and gastric insufflation in a clinical trial. They found that pressure-controlled ventilation was associated with lower peak inspiratory pressure and gastric insufflation less than the other two methods, which suggest that this technique is safer and should be the method of choice for ventilation during apnea patients induction.
Several studies have shown the clinical significance of gastric insufflation during induction of anesthesia in 2009, Paal and colleagues presented the results of two studies in animals: one with them in cardiac arrest and another spontaneous circulation, in the first there was a abdominal compartment syndrome leading to hemodynamic compromise, respiratory, metabolic, and finally multi-organ, in animals with spontaneous circulation, the effects were even worse because there was a reduction in survival and in some gastric insufflation was considered as the cause of heart failure . The authors conclude that gastric insufflation alone can cause heart failure and multiple organ failure occurs much faster the more critical is the patient. , In addition to substantial mechanical cardiopulmonary effects, insufflation of the stomach is a complex problem that can cause regurgitation, aspiration, pneumonia and death. Increases abdominal pressure, elevates the diaphragm, restricts lung movement and thus reduce the compliance of the respiratory system. A reduction in respiratory system compliance may direct further ventilation volume into the stomach when the airway is not protected, thus inducing a vicious circle with each breath, increasing the insufflation of the stomach and decreasing lung ventilation. Added to this the fact that the anesthetic drugs reduce the lower esophageal sphincter pressure and more than 90% of cases in children suction produced in the induction of anesthesia, needless to emphasize the importance of controlling this adverse effect. Control of gastric insufflation by the above would be particularly useful in patients with comorbidities that predispose to regurgitation or cardiac arrest patients.
Children are at greater risk of gastric insufflation during induction of anesthesia because of anatomical and physiological characteristics inherent in the conduct of the respiratory system that promote airway obstruction and the passage of air into the stomach: proportional size of the head and tongue, short neck, small chin, among others. This is compounded by the use of a ventilation without control of parameters such tidal volume, inspiratory time and peak inspiratory pressure, as well as reduction of the lower esophageal sphincter pressure caused by anesthetics and airway devices. It is likely that this increased risk of gastric insufflation is the explanation for the increased incidence of aspiration and respiratory complications found in some studies, particularly during anesthetic induction.
The work of von GoedeckeSeet and are pioneers in this new form of induction of anesthesia with ventilation for the patient safer and more comfortable for the anesthesiologist, using more developed fans that bring new anesthesia machines and allow to get the most out of ventilatory modes that are built. However, lacking adequate methodological designs jobs to validate these techniques in different populations, and one of them is the pediatric population, the characteristics mentioned above would suggest that one of the most favored by this method. Therefore, this paper seeks to establish whether the pressure-controlled ventilation during induction of anesthesia reduces the incidence of gastric insufflation compared with manual ventilation of children aged 1 month to 14 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical ventilation | Experimental | Device: Mechanical ventilation with facial mask1: Active Comparator Children 1 month-14 years of age Intervention:Mechanical ventilation with facial mask during anesthetic induction |
| Manual ventilation | Active comparator | Device: Manual ventilation with facial mask2: Active Comparator Children 1 month-14 years of age Intervention: Manual ventilation with facial mask during anesthetic induction |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I and III children, 1 month-14 years of age
- Children scheduled for surgery or therapeutic procedures under general anesthesia and fasting as defined in the fasting guidelines.
- Responsible adult patients whose accept and sign the informed consent of study.
Key exclusion criteria (5 listed)
- Patients with limited mouth opening or cervical spine extension and classified as difficult airway
- Respiratory diseases
- Children with orogastric or nasogastric tubes
- Children with gastrostomies
- Patients with pulmonary aspiration risk: morbid obesity, intestinal obstruction, gastrointestinal bleeding, gastroparesis, gastroesophageal reflux.
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 |
|---|---|---|
| Mechanical ventilation with facial maskAlso: Mechanical ventilation during anesthetic inductionThis group includes patients with the randomization process are assigned to mechanical ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation. The size of the facial mask is used according to the age and ventilation parameters are: inspiratory pressure 10 cmH2O, PEEP 5 cmH2O, respiratory frequency and relation I/E according to age . | Device | Mechanical ventilation |
| Manual ventilation with facial maskAlso: Manual ventilation during anesthetic inductionThis group includes patients with the randomization process are allocated to manual ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation. The size of the facial mask is used according to the age and ventilator y parameters are selected by the anesthesiologist. | Device | Manual ventilation |
Primary outcome
Gastric insufflation determined by continuous epigastric auscultation until to secure the airway.
Time frame: From anesthetic induction until to secure airway with endotracheal tube, an expected average of 5 minutes
Intervention end up once the anesthesiologist to secure airway patient and during this time the investigator will auscultate the epigastrium
1 secondary outcome
Gastric insufflation determined by aspiration with orogastric tube after to secure the airway
Time frame: First 3 minutes after to secure airway with endotracheal tube
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
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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.
Olga Lucia Giraldo, MD principal investigator
Antioquia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation with facial mask and Manual ventilation with facial mask in people with Gastric Insufflation, run by Universidad de Antioquia at 1 site in Colombia.
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 5 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: status not confirmed, as of the sponsor's last update on 30 Jul 2012. 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 Colombia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Lucia Giraldo, MD (574 2637900, olgiraldos@une.net.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric insufflation determined by continuous epigastric auscultation until to secure the airway. (time frame: From anesthetic induction until to secure airway with endotracheal tube, an expected average of 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2012.