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

Apnoeic Oxygenation Clinical Trial

Official title:

Apnoeic Oxygenation by Nasal Cannula During Airway Management in Children Undergoing General Anaesthesia: A Pilot Randomised Controlled Trial"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271827
• Other study ID #: SP15/134
• Status: Completed
• Phase: N/A
• First received: August 30, 2017
• Last updated: August 31, 2017
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: August 2017
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Apnea
• Apnoeic Oxygenation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Birmingham	Cardiff University, King Abdullah International Medical Research Center

References & Publications (7)

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. — View Citation

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. — View Citation

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. Epub 2006 Jul 27. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The lowest SpO2 observed during airway management	The lowest SpO2 observed during airway management	Estimated: 10 seconds to 3 minutes
Secondary	Number of patients whose SpO2 dropped below 95%	Number of patients whose SpO2 dropped below 95%	Estimated: 10 seconds to 3 minutes
Secondary	Number of patients whose SpO2 dropped below 92%	Number of patients whose SpO2 dropped below 92%	Estimated: 10 seconds to 3 minutes