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

Primary Purpose

Apnoeic Oxygenation

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Apnoeic oxygenation

About this trial

This is an interventional prevention trial for Apnoeic Oxygenation focused on measuring Apnoeic oxygenation, Airway management, Oxygen insufflation, Paediatric general anaesthesia

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Apnoeic oxygenation group

Standard care group

Arm Description

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

Standard airway management

Outcomes

Primary Outcome Measures

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

The lowest SpO2 observed during airway management

Secondary Outcome Measures

Number of patients whose SpO2 dropped below 95%

Number of patients whose SpO2 dropped below 92%

Full Information

NCT ID

NCT03271827

First Posted

August 30, 2017

Last Updated

August 31, 2017

Sponsor

University of Birmingham

Collaborators

King Abdullah International Medical Research Center, Cardiff University

1. Study Identification

Unique Protocol Identification Number

NCT03271827

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Birmingham

Collaborators

King Abdullah International Medical Research Center, Cardiff University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apnoeic Oxygenation

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apnoeic oxygenation group

Arm Type

Experimental

Arm Description

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

Arm Title

Standard care group

Arm Type

No Intervention

Arm Description

Standard airway management

Intervention Type

Device

Intervention Name(s)

Apnoeic oxygenation

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to first event

Description

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

Time Frame

Estimated: 10 seconds to 3 minutes

Title

The lowest SpO2 observed during airway management

Description

The lowest SpO2 observed during airway management

Time Frame

Estimated: 10 seconds to 3 minutes

Secondary Outcome Measure Information:

Title

Number of patients whose SpO2 dropped below 95%

Description

Number of patients whose SpO2 dropped below 95%

Time Frame

Estimated: 10 seconds to 3 minutes

Title

Number of patients whose SpO2 dropped below 92%

Description

Number of patients whose SpO2 dropped below 92%

Time Frame

Estimated: 10 seconds to 3 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lafi Olayan, MSc

Organizational Affiliation

King Abdullah International Research Center (KAIMRC)

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22050948

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.

Results Reference

background

PubMed Identifier

17635423

Citation

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.

Results Reference

background

PubMed Identifier

20400000

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.

Results Reference

background

PubMed Identifier

25536868

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.

Results Reference

background

PubMed Identifier

16674614

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. doi: 10.1111/j.1365-2044.2006.04610.x.

Results Reference

background

PubMed Identifier

10702447

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. doi: 10.1097/00000539-200003000-00022.

Results Reference

background

PubMed Identifier

16873387

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. doi: 10.1093/bja/ael178. Epub 2006 Jul 27.

Results Reference

background

PubMed Identifier

29484172

Citation

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.

Results Reference

derived

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

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