Elective Urologic SurgeriesNCT02224196

Comparison of Peak Airway Pressure and Gastric Insufflation in Manual Ventilation and Pressure-controlled Ventilation With Facemask During Anesthesia Induction in Children

A study testing manual ventilation in people with Elective Urologic Surgeries, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Comparison of peak airway pressure and gastric insufflation in manual ventilation and pressure-controlled ventilation with facemask during anesthesia induction in children. Read more about this study

Who is it for?: Ages 6 months to 7 yearsHealthy volunteers can take part
Conditions the study is for: Elective Urologic Surgeries
What is being tested?: manual ventilation
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteSouth Korea
Study dates: 13 Aug 2014to 30 Jan 2015
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 6 months to 7 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

ASA physical status with I or II
Those parents who signed with informed consents.
Children who are scheduled for elective urologic surgery (aged 6 month to 7 year)

Who cannot join

Risk of aspiration
Oropharyngeal or facial anomaly
history of abdominal (stomach) surgery

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine
Seoul, Seoul, 120-752

Other trials in South Korea

About this study

Comparison of peak airway pressure and gastric insufflation in manual ventilation and pressure-controlled ventilation with facemask during anesthesia induction in children.

Conditions: Elective Urologic Surgeries
Being tested: manual ventilation, pressure-controlled ventilation
Keywords: manual ventilation, pressure-controlled ventilation, peak airway pressure, antral area

What participants receive

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

manual ventilationOther
Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.
pressure-controlled ventilationOther
Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.

Study groups in NCT02224196
Study group	Role	What they receive
manual ventilation	Experimental	Not described Receives: Other: manual ventilation
pressure-controlled ventilation	Active comparator	Not described Receives: Other: pressure-controlled ventilation

What is being measured

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

peak airway pressure
The primary outcome is the difference of peak airway pressure produced by manual ventilation group and pressure-controlled ventilation group during induction of anesthesia.
Measured: 3 minutes

Secondary outcomes (1)

antral area of stomach
All patients' antral area of stomach will be calculated by ultrasound after 3 minutes-facemask ventilation to estimate the quantity of gas insufflation.
Measured: 3 minutes

Timeline

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

13 Aug 201430 Jan 2015

First posted25 Aug 2014 (estimated)
Study start13 Aug 2014
Primary completion30 Jan 2015
Study completion30 Jan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Elective Urologic SurgeriesStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02224196
Sponsor's protocol ID: 4-2014-0270
Status last verified: Jan 2017
First submitted: 19 Aug 2014
Last updated: 25 Jan 2017
Results posted: No
Data monitoring committee: No

Publications

Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
PubMed 17122571
von Goedecke A, Voelckel WG, Wenzel V, Hormann C, Wagner-Berger HG, Dorges V, Lindner KH, Keller C. Mechanical versus manual ventilation via a face mask during the induction of anesthesia: a prospective, randomized, crossover study. Anesth Analg. 2004 Jan;98(1):260-263. doi: 10.1213/01.ANE.0000096190.36875.67.
PubMed 14693633
Kluger MT, Visvanathan T, Myburgh JA, Westhorpe RN. Crisis management during anaesthesia: regurgitation, vomiting, and aspiration. Qual Saf Health Care. 2005 Jun;14(3):e4. doi: 10.1136/qshc.2002.004259.
PubMed 15933301
Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.
PubMed 16563326
Borland LM, Sereika SM, Woelfel SK, Saitz EW, Carrillo PA, Lupin JL, Motoyama EK. Pulmonary aspiration in pediatric patients during general anesthesia: incidence and outcome. J Clin Anesth. 1998 Mar;10(2):95-102. doi: 10.1016/s0952-8180(97)00250-x.
PubMed 9524892
Weiler N, Latorre F, Eberle B, Goedecke R, Heinrichs W. Respiratory mechanics, gastric insufflation pressure, and air leakage of the laryngeal mask airway. Anesth Analg. 1997 May;84(5):1025-8. doi: 10.1097/00000539-199705000-00013.
PubMed 9141925
Weiler N, Heinrichs W, Dick W. Assessment of pulmonary mechanics and gastric inflation pressure during mask ventilation. Prehosp Disaster Med. 1995 Apr-Jun;10(2):101-5. doi: 10.1017/s1049023x00041807.
PubMed 10155411
Seet MM, Soliman KM, Sbeih ZF. Comparison of three modes of positive pressure mask ventilation during induction of anaesthesia: a prospective, randomized, crossover study. Eur J Anaesthesiol. 2009 Nov;26(11):913-6. doi: 10.1097/EJA.0b013e328329b0ab.
PubMed 19390448
Ho-Tai LM, Devitt JH, Noel AG, O'Donnell MP. Gas leak and gastric insufflation during controlled ventilation: face mask versus laryngeal mask airway. Can J Anaesth. 1998 Mar;45(3):206-11. doi: 10.1007/BF03012903.
PubMed 9579256
SNOW RG. THE MUSCLE RELAXANTS AND THE CARDIA, INCLUDING THE CLINICAL MANAGEMENT OF PATIENTS LIKELY TO VOMIT AND REGURGITATE. Br J Anaesth. 1963 Sep;35:541-5. doi: 10.1093/bja/35.9.541. No abstract available.
PubMed 14066104
Lawes EG, Campbell I, Mercer D. Inflation pressure, gastric insufflation and rapid sequence induction. Br J Anaesth. 1987 Mar;59(3):315-8. doi: 10.1093/bja/59.3.315.
PubMed 3828180
Lagarde S, Semjen F, Nouette-Gaulain K, Masson F, Bordes M, Meymat Y, Cros AM. Facemask pressure-controlled ventilation in children: what is the pressure limit? Anesth Analg. 2010 Jun 1;110(6):1676-9. doi: 10.1213/ANE.0b013e3181d8a14c. Epub 2010 Apr 30.
PubMed 20435941
Moynihan RJ, Brock-Utne JG, Archer JH, Feld LH, Kreitzman TR. The effect of cricoid pressure on preventing gastric insufflation in infants and children. Anesthesiology. 1993 Apr;78(4):652-6. doi: 10.1097/00000542-199304000-00007.
PubMed 8466065
Bouvet L, Albert ML, Augris C, Boselli E, Ecochard R, Rabilloud M, Chassard D, Allaouchiche B. Real-time detection of gastric insufflation related to facemask pressure-controlled ventilation using ultrasonography of the antrum and epigastric auscultation in nonparalyzed patients: a prospective, randomized, double-blind study. Anesthesiology. 2014 Feb;120(2):326-34. doi: 10.1097/ALN.0000000000000094.
PubMed 24317204
Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
PubMed 21364462

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Elective Urologic Surgeries trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Peak Airway Pressure and Gastric Insufflation in Manual Ventilation and Pressure-controlled Ventilation With Facemask During Anesthesia Induction in Children
ClinicalTrials.gov ID: NCT02224196
Acronym / sponsor ID: 4-2014-0270
Conditions: Elective Urologic Surgeries
Keywords: manual ventilation, pressure-controlled ventilation, peak airway pressure, antral area
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: 13 Aug 2014 (actual)
Primary completion: 30 Jan 2015 (actual)
Study completion: 30 Jan 2015 (actual)
First posted: 25 Aug 2014 (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.

Comparison of peak airway pressure and gastric insufflation in manual ventilation and pressure-controlled ventilation with facemask during anesthesia induction in children.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
manual ventilation	Experimental	Other: manual ventilation
pressure-controlled ventilation	Active comparator	Other: pressure-controlled ventilation

Who may qualify

Ages: 6 months to 7 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

ASA physical status with I or II
Those parents who signed with informed consents.
Children who are scheduled for elective urologic surgery (aged 6 month to 7 year)

Key exclusion criteria (3 listed)

Risk of aspiration
Oropharyngeal or facial anomaly
history of abdominal (stomach) surgery

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
manual ventilationAnesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.	Other	manual ventilation
pressure-controlled ventilationAnesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.	Other	pressure-controlled ventilation

Primary outcome

peak airway pressure
Time frame: 3 minutes
The primary outcome is the difference of peak airway pressure produced by manual ventilation group and pressure-controlled ventilation group during induction of anesthesia.

1 secondary outcome

antral area of stomach
Time frame: 3 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
Results publication: PubMed 17122571Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
Results publication: PubMed 14693633von Goedecke A, Voelckel WG, Wenzel V, Hormann C, Wagner-Berger HG, Dorges V, Lindner KH, Keller C. Mechanical versus manual ventilation via a face mask during the induction of anesthesia: a prospective, randomized, crossover study. Anesth Analg. 2004 Jan;98(1):260-263. doi: 10.1213/01.ANE.0000096190.36875.67.
Results publication: PubMed 15933301Kluger MT, Visvanathan T, Myburgh JA, Westhorpe RN. Crisis management during anaesthesia: regurgitation, vomiting, and aspiration. Qual Saf Health Care. 2005 Jun;14(3):e4. doi: 10.1136/qshc.2002.004259.
Results publication: PubMed 16563326Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.
Results publication: PubMed 9524892Borland LM, Sereika SM, Woelfel SK, Saitz EW, Carrillo PA, Lupin JL, Motoyama EK. Pulmonary aspiration in pediatric patients during general anesthesia: incidence and outcome. J Clin Anesth. 1998 Mar;10(2):95-102. doi: 10.1016/s0952-8180(97)00250-x.
Results publication: PubMed 9141925Weiler N, Latorre F, Eberle B, Goedecke R, Heinrichs W. Respiratory mechanics, gastric insufflation pressure, and air leakage of the laryngeal mask airway. Anesth Analg. 1997 May;84(5):1025-8. doi: 10.1097/00000539-199705000-00013.
Results publication: PubMed 10155411Weiler N, Heinrichs W, Dick W. Assessment of pulmonary mechanics and gastric inflation pressure during mask ventilation. Prehosp Disaster Med. 1995 Apr-Jun;10(2):101-5. doi: 10.1017/s1049023x00041807.
Results publication: PubMed 19390448Seet MM, Soliman KM, Sbeih ZF. Comparison of three modes of positive pressure mask ventilation during induction of anaesthesia: a prospective, randomized, crossover study. Eur J Anaesthesiol. 2009 Nov;26(11):913-6. doi: 10.1097/EJA.0b013e328329b0ab.
Results publication: PubMed 9579256Ho-Tai LM, Devitt JH, Noel AG, O'Donnell MP. Gas leak and gastric insufflation during controlled ventilation: face mask versus laryngeal mask airway. Can J Anaesth. 1998 Mar;45(3):206-11. doi: 10.1007/BF03012903.
Results publication: PubMed 14066104SNOW RG. THE MUSCLE RELAXANTS AND THE CARDIA, INCLUDING THE CLINICAL MANAGEMENT OF PATIENTS LIKELY TO VOMIT AND REGURGITATE. Br J Anaesth. 1963 Sep;35:541-5. doi: 10.1093/bja/35.9.541. No abstract available.
Results publication: PubMed 3828180Lawes EG, Campbell I, Mercer D. Inflation pressure, gastric insufflation and rapid sequence induction. Br J Anaesth. 1987 Mar;59(3):315-8. doi: 10.1093/bja/59.3.315.
Results publication: PubMed 20435941Lagarde S, Semjen F, Nouette-Gaulain K, Masson F, Bordes M, Meymat Y, Cros AM. Facemask pressure-controlled ventilation in children: what is the pressure limit? Anesth Analg. 2010 Jun 1;110(6):1676-9. doi: 10.1213/ANE.0b013e3181d8a14c. Epub 2010 Apr 30.

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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.

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 manual ventilation in people with Elective Urologic Surgeries, run by Yonsei University at 1 site in South Korea.

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 3 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: finished, as of the sponsor's last update on 25 Jan 2017. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

peak airway pressure (time frame: 3 minutes). 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 NCT02224196, which also lists 17 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 Jan 2017.