NCT02224196

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2015

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

August 19, 2014

Last Update Submit

January 23, 2017

Conditions

Elective Urologic Surgeries

Keywords

manual ventilationpressure-controlled ventilationpeak airway pressureantral area

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 minutes

Secondary Outcomes (1)

  • antral area of stomach

    3 minutes

Study Arms (2)

manual ventilation

EXPERIMENTAL
Other: manual ventilation

pressure-controlled ventilation

ACTIVE COMPARATOR
Other: pressure-controlled ventilation

Interventions

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.

manual 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.

pressure-controlled ventilation

Eligibility Criteria

Age6 Months - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (17)

  • 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.

    PMID: 17122571RESULT

  • 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.

    PMID: 14693633RESULT

  • 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.

    PMID: 15933301RESULT

  • 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.

    PMID: 16563326RESULT

  • 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.

    PMID: 9524892RESULT

  • 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.

    PMID: 9141925RESULT

  • 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.

    PMID: 10155411RESULT

  • 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.

    PMID: 19390448RESULT

  • 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.

    PMID: 9579256RESULT

  • 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.

    PMID: 14066104RESULT

  • 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.

    PMID: 3828180RESULT

  • 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.

    PMID: 20435941RESULT

  • 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.

    PMID: 8466065RESULT

  • 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.

    PMID: 24317204RESULT

  • 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.

    PMID: 21364462RESULT

  • Schmitz A, Thomas S, Melanie F, Rabia L, Klaghofer R, Weiss M, Kellenberger C. Ultrasonographic gastric antral area and gastric contents volume in children. Paediatr Anaesth. 2012 Feb;22(2):144-9. doi: 10.1111/j.1460-9592.2011.03718.x. Epub 2011 Oct 14.

    PMID: 21999211RESULT

  • Brimacomb J, Keller C, Kurian S, Myles J. Reliability of epigastric auscultation to detect gastric insufflation. Br J Anaesth. 2002 Jan;88(1):127-9. doi: 10.1093/bja/88.1.127.

    PMID: 11881867RESULT

Study Design

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

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 25, 2014

Study Start

August 13, 2014

Primary Completion

January 30, 2015

Study Completion

January 30, 2015

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

KR(1)