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Continuous Positive Airway PressureNCT03432390

Positive Pressure at Induction of Anesthesia in Children

A study testing Continuous Positive Airway Pressure and Open system ventilation in people with Continuous Positive Airway Pressure and Hypoxia, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.

Completed

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

Official record
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Trial summary

SCENARIO: Hypoxemia is one of the most common adverse events during the induction of general anesthesia and may culminate with more serious complications such as cardiac arrest and death. Read more about this study

Who is it for?
Ages 2 to 6 yearsHealthy volunteers can take part
What is being tested?
Continuous Positive Airway Pressure and Open system ventilation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteBrazil
Study dates
6 Mar 2018to 23 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 2 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Pre-school children, ASA physical status I or II, Children undergoing general anesthesia for elective surgery

Who cannot join

  • Pre-existing parenchymal lung disease, Children cyanotic or with oxyhemoglobin saturation less than 95% before anesthetic induction, Recent history (<4 weeks) or current upper respiratory tract infection

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital das Clínicas de Pernambuco

    Recife, Pernambuco

Other trials in Brazil

About this study

Official title: Continuous Positive Airway Pressure During General Anesthesia Induction For Elective Pediatric Surgery: Randomized Clinical Trial

SCENARIO: Hypoxemia is one of the most common adverse events during the induction of general anesthesia and may culminate with more serious complications such as cardiac arrest and death. Pediatric patients, due to their anatomical and physiological characteristics, are more likely to develop hemoglobin desaturation levels. Some preventive strategies are used during this period to reduce the chances of occurrence of adverse event. Continuous Positive Airway Pressure (CPAP) may be useful during anesthetic induction in delaying the drop in oxygen levels in the blood by increasing this body gas reserves. OBJECTIVES: To assess the effectiveness of CPAP during anesthetic induction in increasing apnea time until hemoglobin saturation falls to 95% in children undergoing general anesthesia for elective surgery. METHODS: Phase III, parallel, randomized clinical trial to be developed at the Teaching Hospital of the Federal University of Pernambuco. Patients (72) are divided into two groups (36 in each) in which all patients will spontaneously ventilate: group C will receive CPAP and group A will use the open system. Children of pre-school age with physical status I or II, according to the American Anesthesia Society, candidates for elective surgery under general anesthesia will be included. Patients with pre-existing parenchymal lung disease, cyanotic children or patients with oxyhemoglobin saturation <95% prior to anesthetic induction and recent history (<4 weeks) or active upper respiratory tract infection will be excluded. The descriptive statistical analysis will be carried out through measures of central tendency and dispersion for quantitative variables and via distribution of frequencies for qualitative variables. ETHICAL ASPECTS: This work will respect human rights, principles of bioethics, the resolution 466/2012 of the National Health Council and the statement from Helsinki. Submission and approval by the research ethics committee is required prior to data collection. KEYWORDS: Continuous Positive Airway Pressure, Hypoxia, General Anesthesia

Being tested
Continuous Positive Airway Pressure, Open system ventilation
Medical subject headings
Hypoxia

What participants receive

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

  • Continuous Positive Airway PressureDevice

    A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station

  • Open system ventilationDevice

    Facemask ventilation adapted to the anesthesia work station

Study groups in NCT03432390
Study groupRoleWhat they receive
CPAPExperimentalNot described
Receives: Device: Continuous Positive Airway Pressure
ControlActive comparatorNot described
Receives: Device: Open system ventilation

What is being measured

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

  1. Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels

    In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare the time between onset of apnea and the drop in 95% oxyhemoglobin saturation between the groups

    Measured: During induction of general anesthesia (up to five minutes after beginning of apnea)

Secondary outcomes (2)

  1. Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry

    In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare: The time to recovery of oxyhemoglobin saturation levels in pre-apnea pulse oximetry between groups

    Measured: During induction of general anesthesia (up to five minutes after beginning of apnea)

  2. Number of Participants That Experienced Complications While Undergoing General Anesthesia

    In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare: The frequency of complications (laryngospasm, hypoxemia, bradycardia, cardiorespiratory arrest, death) between the groups

    Measured: During induction of general anesthesia (up to five minutes after beginning of apnea)

Timeline

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

  1. First posted14 Feb 2018
  2. Study start6 Mar 2018
  3. Primary completion17 Jan 2019
  4. Study completion23 May 2019

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
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03432390
Sponsor's protocol ID
79591417.0.0000.5201
Status last verified
Nov 2019
First submitted
7 Feb 2018
Last updated
9 Dec 2019
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Arhem P, Klement G, Nilsson J. Mechanisms of anesthesia: towards integrating network, cellular, and molecular level modeling. Neuropsychopharmacology. 2003 Jul;28 Suppl 1:S40-7. doi: 10.1038/sj.npp.1300142.

    PubMed 12827143

  • Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.

    PubMed 21190458

  • Boonmak P, Boonmak S, Pattanittum P. High initial concentration versus low initial concentration sevoflurane for inhalational induction of anaesthesia. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD006837. doi: 10.1002/14651858.CD006837.pub2.

    PubMed 22972100

  • Park JH, Kim JY, Lee JM, Kim YH, Jeong HW, Kil HK. Manual vs. pressure-controlled facemask ventilation for anaesthetic induction in paralysed children: a randomised controlled trial. Acta Anaesthesiol Scand. 2016 Sep;60(8):1075-83. doi: 10.1111/aas.12737. Epub 2016 Apr 24.

    PubMed 27109459

  • von Ungern-Sternberg BS, Boda K, Chambers NA, Rebmann C, Johnson C, Sly PD, Habre W. Risk assessment for respiratory complications in paediatric anaesthesia: a prospective cohort study. Lancet. 2010 Sep 4;376(9743):773-83. doi: 10.1016/S0140-6736(10)61193-2.

    PubMed 20816545

  • Ehsan Z, Mahmoud M, Shott SR, Amin RS, Ishman SL. The effects of anesthesia and opioids on the upper airway: A systematic review. Laryngoscope. 2016 Jan;126(1):270-84. doi: 10.1002/lary.25399. Epub 2015 Jul 21.

    PubMed 26198715

  • Hedenstierna G, Edmark L. Effects of anesthesia on the respiratory system. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):273-84. doi: 10.1016/j.bpa.2015.08.008. Epub 2015 Sep 18.

    PubMed 26643094

  • Bouroche G, Bourgain JL. Preoxygenation and general anesthesia: a review. Minerva Anestesiol. 2015 Aug;81(8):910-20. Epub 2015 Jun 5.

    PubMed 26044934

  • Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.

    PubMed 28099321

  • Gonzalez LP, Pignaton W, Kusano PS, Modolo NS, Braz JR, Braz LG. Anesthesia-related mortality in pediatric patients: a systematic review. Clinics (Sao Paulo). 2012;67(4):381-7. doi: 10.6061/clinics/2012(04)12.

    PubMed 22522764

  • Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.

    PubMed 26705976

  • Long E, Sabato S, Babl FE. Endotracheal intubation in the pediatric emergency department. Paediatr Anaesth. 2014 Dec;24(12):1204-11. doi: 10.1111/pan.12490. Epub 2014 Jul 15.

    PubMed 25039321

  • Bharti N, Batra YK, Kaur H. Paediatric perioperative cardiac arrest and its mortality: database of a 60-month period from a tertiary care paediatric centre. Eur J Anaesthesiol. 2009 Jun;26(6):490-5. doi: 10.1097/EJA.0b013e328323dac0.

    PubMed 19300269

  • Gonzalez LP, Braz JR, Modolo MP, de Carvalho LR, Modolo NS, Braz LG. Pediatric perioperative cardiac arrest and mortality: a study from a tertiary teaching hospital. Pediatr Crit Care Med. 2014 Nov;15(9):878-84. doi: 10.1097/PCC.0000000000000248.

    PubMed 25226499

  • Harless J, Ramaiah R, Bhananker SM. Pediatric airway management. Int J Crit Illn Inj Sci. 2014 Jan;4(1):65-70. doi: 10.4103/2229-5151.128015.

    PubMed 24741500

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Positive Airway Pressure and Open system ventilation in people with Continuous Positive Airway Pressure and Hypoxia, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.

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 1 inclusion and 1 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 9 Dec 2019. 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 Brazil. 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?

Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels (time frame: During induction of general anesthesia (up to five minutes after beginning of apnea)). 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 NCT03432390, which also lists 37 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 9 Dec 2019.

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