Apnoeic Oxygenation by Nasal Cannula During Airway Management in Children Undergoing General Anaesthesia.

NCT03271827 | Completed DMC

• 1 other identifier: SP15/134
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Airway management is a core clinical skill in anaesthesia. Pre-oxygenation prior to induction of anaesthesia is standard practice to prevent desaturation. Apnoeic oxygenation in adults is effective and prolongs the time to desaturation. The effectiveness of apnoeic oxygenation in the adult is well document, however evidence in the paediatric is lacking. Therefore, the aim of this study was to investigate the effectiveness of apnoeic oxygenation during airway management in children. This was a pilot randomised controlled trial. Patients were randomised to either receive apnoeic oxygenation or standard care during the induction of anaesthesia. The primary outcome was the duration of safe apnoea, defined as a composite of the time to first event, either time for SpO2 to drop to 92% or time to successfully secure the airway, and the lowest SpO2 observed during airway management. Secondary outcomes were number of patients whose SpO2 dropped below 95% and number of patients whose SpO2 dropped below 92%.

Conditions

Apnoeic Oxygenation

Keywords

Apnoeic oxygenation; Airway management; Oxygen insufflation; Paediatric general anaesthesia

Outcome Measures

Primary Outcomes (2)

• Time to first event

  Time to first event: either time for SpO2 to fall to 92% or time to successfully secure the airway as usual practice without allowing desaturation

  Estimated: 10 seconds to 3 minutes

• The lowest SpO2 observed during airway management

  The lowest SpO2 observed during airway management

  Estimated: 10 seconds to 3 minutes

Secondary Outcomes (2)

• Number of patients whose SpO2 dropped below 95%

  Estimated: 10 seconds to 3 minutes

• Number of patients whose SpO2 dropped below 92%

  Estimated: 10 seconds to 3 minutes

Study Arms (2)

Apnoeic oxygenation group

EXPERIMENTAL

Standard airway management + 3 L/min of oxygen by nasal cannula

Device: Apnoeic oxygenation

Standard care group

NO INTERVENTION

Standard airway management

Interventions

Apnoeic oxygenation DEVICE

3 L/min of oxygen by nasal cannula during as apnoeic oxygenation during airway management.

Apnoeic oxygenation group

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients were included who were scheduled for elective surgery under general anaesthesia.
• Age: one eight years old.
• ASA I and II only.
• Patients with normal cardiorespiratory function.

You may not qualify if:

• Children undergoing dental surgeries in which nasal intubation is needed.
• Patients who suffered from quick drops in oxygen saturation more rapidly than healthy children due to different reasons such as: respiratory and pulmonary diseases, active or recent upper respiratory tract infection, syndromes with cardiopulmonary pathologies, cardiac anomalies, anaemia, depressed respiratory effort, ventilation/perfusion imbalance, Obstructive Sleep Apnoea (OSA), and airway obstruction.
• Patients reported with nasal obstruction.
• Patients with grades of laryngoscopic view (Cormack Lahane) greater than II, which indicates upper airway obstruction.

Sponsors & Collaborators

• University of Birmingham: lead
• King Abdullah International Medical Research Center: collaborator
• Cardiff University: collaborator

Related Publications (8)

• Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.

  PMID: 22050948 BACKGROUND

• Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia. 2007 Aug;62(8):769-73. doi: 10.1111/j.1365-2044.2007.05104.x.

  PMID: 17635423 BACKGROUND

• Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.

  PMID: 20400000 BACKGROUND

• Wimalasena Y, Burns B, Reid C, Ware S, Habig K. Apneic oxygenation was associated with decreased desaturation rates during rapid sequence intubation by an Australian helicopter emergency medicine service. Ann Emerg Med. 2015 Apr;65(4):371-6. doi: 10.1016/j.annemergmed.2014.11.014. Epub 2014 Dec 20.

  PMID: 25536868 BACKGROUND

• Taha SK, Siddik-Sayyid SM, El-Khatib MF, Dagher CM, Hakki MA, Baraka AS. Nasopharyngeal oxygen insufflation following pre-oxygenation using the four deep breath technique. Anaesthesia. 2006 May;61(5):427-30. doi: 10.1111/j.1365-2044.2006.04610.x.

  PMID: 16674614 BACKGROUND

• Hardman JG, Wills JS, Aitkenhead AR. Factors determining the onset and course of hypoxemia during apnea: an investigation using physiological modelling. Anesth Analg. 2000 Mar;90(3):619-24. doi: 10.1097/00000539-200003000-00022.

  PMID: 10702447 BACKGROUND

• Hardman JG, Wills JS. The development of hypoxaemia during apnoea in children: a computational modelling investigation. Br J Anaesth. 2006 Oct;97(4):564-70. doi: 10.1093/bja/ael178. Epub 2006 Jul 27.

  PMID: 16873387 BACKGROUND

• Olayan L, Alatassi A, Patel J, Milton S. Apnoeic oxygenation by nasal cannula during airway management in children undergoing general anaesthesia: a pilot randomised controlled trial. Perioper Med (Lond). 2018 Feb 21;7:3. doi: 10.1186/s13741-018-0083-x. eCollection 2018.

  PMID: 29484172 DERIVED

Study Officials

• Lafi Olayan, MSc

  King Abdullah International Research Center (KAIMRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research fellow

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 5, 2017
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 5, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share