Airway ObstructionNCT06742476
Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children
A study testing nasal cannula in people with Airway Obstruction, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
During general anesthesia, the administration of anesthetics and muscle relaxants induces apnea, wherein spontaneous breathing ceases . Pediatric patients, characterized by their higher oxygen consumption rate and smaller functional residual capacity, are particularly susceptible to hypoxemia during apneic episodes . Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients (3 - 10 Years).
- Patients who were scheduled for adenotonsillectomy.
- ASA I and II
Who cannot join
- When nasal intubation is needed.
- Patients reported with nasal obstruction.
- Patients with any respiratory disease like asthma or recent upper respiratory tract infection.
- Patients with obstructive sleep apnea
- Patients with congenital heart disease
- Patients suspected difficult intubation or syndromatic patients eg : down syndrome , Goldenhar Syndrome , Pierre Robin syndrome … etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children Undergoing Adenotonsillectomy (As Partially Obstructed Airway)
During general anesthesia, the administration of anesthetics and muscle relaxants induces apnea, wherein spontaneous breathing ceases . Pediatric patients, characterized by their higher oxygen consumption rate and smaller functional residual capacity, are particularly susceptible to hypoxemia during apneic episodes . This vulnerability to hypoxemia underscores the critical need for effective oxygenation strategies during anesthesia. Apneic oxygenation, the provision of oxygen without concurrent tidal volume delivery, emerges as a vital technique in pediatric anesthesia, playing a pivotal role in both routine and challenging airway management scenarios .
In modern practice, apneic oxygenation during airway management denotes the uninterrupted supply of oxygen, extending the window for maintaining safe oxygen saturation levels during the apneic phase . This technique holds particular significance in pediatric patients undergoing adenotonsillectomy, where the delicate balance of oxygenation is paramount .
Adenotonsillectomy, a common surgical procedure in pediatric patients, poses unique challenges in airway management . The procedure involves the removal of the adenoids and tonsils, often necessitating general anesthesia and temporary airway obstruction . Furthermore, the potential for blood and secretions in the oropharynx increases the risk of airway compromise during the perioperative period. In this context, ensuring adequate oxygenation is essential to mitigate the risk of hypoxemia and its associated complications In this randomized clinical trial, the investigators aim to evaluate the efficacy and safety of apneic oxygenation using nasal cannula in pediatric patients undergoing adenotonsillectomy under general anesthesia. By assessing our primary outcome and secondary outcomes, the investigators seek to contribute valuable insights into optimizing anesthesia management protocols for this vulnerable patient population.
Read the detailed description
Following permission from the local institutional review board and institutional ethics committee, this study will be carried out at the FAYOUM University hospital. The research will employ a single -blinded, randomized, and controlled approach.
Prior to recruitment and randomization, detailed consent will be obtained from the parents or legal guardians of eligible patients.
Patients were randomly allocated 1: 1 to the two study groups:
Group (A):
Patients in the group A will undergo tracheal intubation without apneic oxygenation
Group (B):
Patients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula The randomization will be computer generated random number and the randomization sequence will be kept hidden in sealed opaque envelopes just opened after recruitment and admittance to the operating room. The group's allocations will be only blinded to parents of children.
In both the control and experimental groups, subjects will undergo a standardized general anesthesia protocol. All pediatric participants will receive premedication in the form of 0.5 mg/kg rectal midazolam upon admission to the operating theater, patients will be comfortably positioned on the operating table. Standard monitoring devices, including electrocardiography (ECG), non-invasive blood pressure (NIBP) measurement, pulse oximetry, and end-tidal carbon dioxide (EtCO2) monitoring, will be affixed. Intravenous access will be established to facilitate fluid and medication administration. In instances where venous access proves challenging, patients will be induced with inhaled sevoflurane at 8% concentration, followed by the insertion of an intravenous cannula. Subsequently, anesthetic induction will be achieved using a combination of 2 - 3 mg/kg of Propofol, 1 mcg/kg of Fentanyl, and 0.5 mg/kg of Atracurium. Following induction, bag-mask ventilation with 100% oxygen and flow rates of 6-8 litres min will be initiated for 3 minutes Ventilation will then be discontinued. In the apneic oxygenation group, nasal cannula will be employed to administer continuous oxygenation, utilizing a flow rate of 0.2 L/kg, during the apneic phase while tracheal intubation is performed. Successful intubation will be confirmed by auscultation and the appearance of a square wave capnogragh.
Following intubation, SpO2 levels will be recorded, and mechanical ventilation will be instituted to maintain normocapnia and oxygenation within predetermined target ranges.
In case of desaturation, the procedure will be discontinued as soon as the SpO2 reach 92%. Bag mask ventilation with 100% oxygen will be started until spo2 reach 100%, Intubation will then be performed by the supervising consultant anesthesiologist
- Conditions
- Airway Obstruction
- Being tested
- nasal cannula
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal cannulaDevice
In the apneic oxygenation group, nasal cannula will be employed to administer continuous oxygenation, utilizing a flow rate of 0.2 L/kg, during the apneic phase while tracheal intubation is performed. Successful intubation will be confirmed by auscultation and the appearance of a square wave capnogragh.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients in the group A will undergo tracheal intubation without apneic oxygenation |
| apniec oxygenation group | Experimental | Patients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula Receives: Device: nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest oxygen saturation during tracheal intubation.
Following intubation, SpO2 levels will be recorded
Measured: at the end of intubation procedure
Secondary outcomes (7)
Number of patients that their spo2 dropped to 95%.
Measured: at the end of intubation procedure
Number of patients that their spo2 dropped to 92%.
Measured: at the end of intubation procedure
Number of patients that their spo2 dropped to below 92%.
Measured: at the end of intubation procedure
Spo2 base line Spo2 after bag and mask ventillation and Spo2 immediately after intubation.
Measured: at the end of intubation procedure
Number of intubation attempts.
Measured: at the end of intubation procedure
Time of intubation.
Measured: at the end of intubation procedure
Number of patients developed bradycardia.
Measured: at the end of the study ( 6 months )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start15 Dec 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Gaber Ragab, Fayoum University Hospital
- Investigators
- Safaa Gaber Ragab, MD, Principal investigator, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742476
- Sponsor's protocol ID
- M738
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bhananker SM, Ramamoorthy C, Geiduschek JM, Posner KL, Domino KB, Haberkern CM, Campos JS, Morray JP. Anesthesia-related cardiac arrest in children: update from the Pediatric Perioperative Cardiac Arrest Registry. Anesth Analg. 2007 Aug;105(2):344-50. doi: 10.1213/01.ane.0000268712.00756.dd.
PubMed 17646488van Munster JJCM, Zamanipoor Najafabadi AH, Schoones JW, Peul WC, van den Hout WB, van Benthem PPG. The impact of new evidence on regional variation in paediatric tonsillectomy and adenoidectomy: a historical review. J Laryngol Otol. 2020 Dec;134(12):1036-1043. doi: 10.1017/S002221512000273X.
PubMed 33431080Noda M, Shimada MD, Koshu R, Saito C, Ito M. Efficacy of endoscopic powered intracapsular tonsillectomy and adenoidectomy for pediatric obstructive sleep apnea: A retrospective case-control study. Auris Nasus Larynx. 2023 Jun;50(3):383-388. doi: 10.1016/j.anl.2022.08.008. Epub 2022 Sep 7.
PubMed 36085267Randall DA. Current Indications for Tonsillectomy and Adenoidectomy. J Am Board Fam Med. 2020 Nov-Dec;33(6):1025-1030. doi: 10.3122/jabfm.2020.06.200038.
PubMed 33219085Soneru CN, Hurt HF, Petersen TR, Davis DD, Braude DA, Falcon RJ. Apneic nasal oxygenation and safe apnea time during pediatric intubations by learners. Paediatr Anaesth. 2019 Jun;29(6):628-634. doi: 10.1111/pan.13645. Epub 2019 Apr 29.
PubMed 30943324Olayan 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.
PubMed 29484172Lyons C, Callaghan M. Uses and mechanisms of apnoeic oxygenation: a narrative review. Anaesthesia. 2019 Apr;74(4):497-507. doi: 10.1111/anae.14565. Epub 2019 Feb 19.
PubMed 30784037Kleine-Brueggeney M, Grosshauser M, Greif R. Apneic oxygenation in pediatric anesthesia. Curr Opin Anaesthesiol. 2022 Jun 1;35(3):361-366. doi: 10.1097/ACO.0000000000001127.
PubMed 35671025Nimmagadda 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 28099321Tiradentes TAA, Einav S, Braz JRC, Nunes-Nogueira VS, Betini M, Corrente JE, Braz MG, Braz LG. Global anaesthesia-related cardiac arrest rates in children: a systematic review and meta-analysis. Br J Anaesth. 2023 Nov;131(5):901-913. doi: 10.1016/j.bja.2023.08.023. Epub 2023 Sep 22.
PubMed 37743151
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children Undergoing Adenotonsillectomy (As Partially Obstructed Airway)
- ClinicalTrials.gov ID
- NCT06742476
- Acronym / sponsor ID
- M738
- Conditions
- Airway Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During general anesthesia, the administration of anesthetics and muscle relaxants induces apnea, wherein spontaneous breathing ceases . Pediatric patients, characterized by their higher oxygen consumption rate and smaller functional residual capacity, are particularly susceptible to hypoxemia during apneic episodes . This vulnerability to hypoxemia underscores the critical need for effective oxygenation strategies during anesthesia. Apneic oxygenation, the provision of oxygen without concurrent tidal volume delivery, emerges as a vital technique in pediatric anesthesia, playing a pivotal role in both routine and challenging airway management scenarios .
In modern practice, apneic oxygenation during airway management denotes the uninterrupted supply of oxygen, extending the window for maintaining safe oxygen saturation levels during the apneic phase . This technique holds particular significance in pediatric patients undergoing adenotonsillectomy, where the delicate balance of oxygenation is paramount .
Adenotonsillectomy, a common surgical procedure in pediatric patients, poses unique challenges in airway management . The procedure involves the removal of the adenoids and tonsils, often necessitating general anesthesia and temporary airway obstruction . Furthermore, the potential for blood and secretions in the oropharynx increases the risk of airway compromise during the perioperative period. In this context, ensuring adequate oxygenation is essential to mitigate the risk of hypoxemia and its associated complications In this randomized clinical trial, the investigators aim to evaluate the efficacy and safety of apneic oxygenation using nasal cannula in pediatric patients undergoing adenotonsillectomy under general anesthesia. By assessing our primary outcome and secondary outcomes, the investigators seek to contribute valuable insights into optimizing anesthesia management protocols for this vulnerable patient population.
Detailed description
Following permission from the local institutional review board and institutional ethics committee, this study will be carried out at the FAYOUM University hospital. The research will employ a single -blinded, randomized, and controlled approach.
Prior to recruitment and randomization, detailed consent will be obtained from the parents or legal guardians of eligible patients.
Patients were randomly allocated 1: 1 to the two study groups:
Group (A):
Patients in the group A will undergo tracheal intubation without apneic oxygenation
Group (B):
Patients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula The randomization will be computer generated random number and the randomization sequence will be kept hidden in sealed opaque envelopes just opened after recruitment and admittance to the operating room. The group's allocations will be only blinded to parents of children.
In both the control and experimental groups, subjects will undergo a standardized general anesthesia protocol. All pediatric participants will receive premedication in the form of 0.5 mg/kg rectal midazolam upon admission to the operating theater, patients will be comfortably positioned on the operating table. Standard monitoring devices, including electrocardiography (ECG), non-invasive blood pressure (NIBP) measurement, pulse oximetry, and end-tidal carbon dioxide (EtCO2) monitoring, will be affixed. Intravenous access will be established to facilitate fluid and medication administration. In instances where venous access proves challenging, patients will be induced with inhaled sevoflurane at 8% concentration, followed by the insertion of an intravenous cannula. Subsequently, anesthetic induction will be achieved using a combination of 2 - 3 mg/kg of Propofol, 1 mcg/kg of Fentanyl, and 0.5 mg/kg of Atracurium. Following induction, bag-mask ventilation with 100% oxygen and flow rates of 6-8 litres min will be initiated for 3 minutes Ventilation will then be discontinued. In the apneic oxygenation group, nasal cannula will be employed to administer continuous oxygenation, utilizing a flow rate of 0.2 L/kg, during the apneic phase while tracheal intubation is performed. Successful intubation will be confirmed by auscultation and the appearance of a square wave capnogragh.
Following intubation, SpO2 levels will be recorded, and mechanical ventilation will be instituted to maintain normocapnia and oxygenation within predetermined target ranges.
In case of desaturation, the procedure will be discontinued as soon as the SpO2 reach 92%. Bag mask ventilation with 100% oxygen will be started until spo2 reach 100%, Intubation will then be performed by the supervising consultant anesthesiologist
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients in the group A will undergo tracheal intubation without apneic oxygenation |
| apniec oxygenation group | Experimental | Device: nasal cannulaPatients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients (3 - 10 Years).
- Patients who were scheduled for adenotonsillectomy.
- ASA I and II
Key exclusion criteria (6 listed)
- When nasal intubation is needed.
- Patients reported with nasal obstruction.
- Patients with any respiratory disease like asthma or recent upper respiratory tract infection.
- Patients with obstructive sleep apnea
- Patients with congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal cannulaIn the apneic oxygenation group, nasal cannula will be employed to administer continuous oxygenation, utilizing a flow rate of 0.2 L/kg, during the apneic phase while tracheal intubation is performed. Successful intubation will be confirmed by auscultation and the appearance of a square wave capnogragh. | Device | apniec oxygenation group |
Primary outcome
Lowest oxygen saturation during tracheal intubation.
Time frame: at the end of intubation procedure
Following intubation, SpO2 levels will be recorded
7 secondary outcomes
Number of patients that their spo2 dropped to 95%.
Time frame: at the end of intubation procedure
Number of patients that their spo2 dropped to 92%.
Time frame: at the end of intubation procedure
Number of patients that their spo2 dropped to below 92%.
Time frame: at the end of intubation procedure
Spo2 base line Spo2 after bag and mask ventillation and Spo2 immediately after intubation.
Time frame: at the end of intubation procedure
Number of intubation attempts.
Time frame: at the end of intubation procedure
Time of intubation.
Time frame: at the end of intubation procedure
Number of patients developed bradycardia.
Time frame: at the end of the study ( 6 months )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 17646488Bhananker SM, Ramamoorthy C, Geiduschek JM, Posner KL, Domino KB, Haberkern CM, Campos JS, Morray JP. Anesthesia-related cardiac arrest in children: update from the Pediatric Perioperative Cardiac Arrest Registry. Anesth Analg. 2007 Aug;105(2):344-50. doi: 10.1213/01.ane.0000268712.00756.dd.
- Background: PubMed 33431080van Munster JJCM, Zamanipoor Najafabadi AH, Schoones JW, Peul WC, van den Hout WB, van Benthem PPG. The impact of new evidence on regional variation in paediatric tonsillectomy and adenoidectomy: a historical review. J Laryngol Otol. 2020 Dec;134(12):1036-1043. doi: 10.1017/S002221512000273X.
- Background: PubMed 36085267Noda M, Shimada MD, Koshu R, Saito C, Ito M. Efficacy of endoscopic powered intracapsular tonsillectomy and adenoidectomy for pediatric obstructive sleep apnea: A retrospective case-control study. Auris Nasus Larynx. 2023 Jun;50(3):383-388. doi: 10.1016/j.anl.2022.08.008. Epub 2022 Sep 7.
- Background: PubMed 33219085Randall DA. Current Indications for Tonsillectomy and Adenoidectomy. J Am Board Fam Med. 2020 Nov-Dec;33(6):1025-1030. doi: 10.3122/jabfm.2020.06.200038.
- Background: PubMed 30943324Soneru CN, Hurt HF, Petersen TR, Davis DD, Braude DA, Falcon RJ. Apneic nasal oxygenation and safe apnea time during pediatric intubations by learners. Paediatr Anaesth. 2019 Jun;29(6):628-634. doi: 10.1111/pan.13645. Epub 2019 Apr 29.
- Background: PubMed 29484172Olayan 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.
- Background: PubMed 30784037Lyons C, Callaghan M. Uses and mechanisms of apnoeic oxygenation: a narrative review. Anaesthesia. 2019 Apr;74(4):497-507. doi: 10.1111/anae.14565. Epub 2019 Feb 19.
- Background: PubMed 35671025Kleine-Brueggeney M, Grosshauser M, Greif R. Apneic oxygenation in pediatric anesthesia. Curr Opin Anaesthesiol. 2022 Jun 1;35(3):361-366. doi: 10.1097/ACO.0000000000001127.
- Background: PubMed 28099321Nimmagadda 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.
- Results publication: PubMed 37743151Tiradentes TAA, Einav S, Braz JRC, Nunes-Nogueira VS, Betini M, Corrente JE, Braz MG, Braz LG. Global anaesthesia-related cardiac arrest rates in children: a systematic review and meta-analysis. Br J Anaesth. 2023 Nov;131(5):901-913. doi: 10.1016/j.bja.2023.08.023. Epub 2023 Sep 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safaa Gaber Ragab, MD principal investigator
Faculty of medicine, Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal cannula in people with Airway Obstruction, run by Fayoum University Hospital at 1 site in Egypt.
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 3 inclusion and 6 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 8 Dec 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lowest oxygen saturation during tracheal intubation. (time frame: at the end of intubation procedure). 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 NCT06742476, which also lists 10 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 8 Dec 2025.