Different Low Flow Rates on Gas Exchange in Children During Apnea

NCT06659887 | Recruiting

• 1 other identifier: D377
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of Low flow apneic oxygenation in pediatrics on rate of accumulation of transcutaneous carbon dioxide also, had been studied, compared to high flow rates. Furthermore, a recent study in apneic anesthetized adult discussed the rate of accumulation of carbon dioxide in arterial blood during 4 min of apnea but, no study in pediatrics discussed the effect of different low flow rates on rate of carbon dioxide accumulation during a period of apnea. Aim of the study: the authors aim to study the effect of different flow rates of low flow oxygenation during 3 min of apnea in anesthetized children on the rate of accumulation of carbon dioxide

Conditions

Apnea

Keywords

Low flow rate; Children; Gas exchange

Outcome Measures

Primary Outcomes (1)

• rise of arterial pressure of carbon dioxide

  mmHg

  between 60s and 180s time points of apnea

Secondary Outcomes (11)

• Time to oxygen desaturation

  5 seconds after the onset of apnea

• Number of patients reached 6 minutes of apnea

  1 minute after end of apneic oxygenation

• Pressure difference between the end-tidal carbon dioxide and the arterial carbon dioxide

  Between the end of apnea and the preceding blood gas

• Mean difference in arterial pressure of oxygen

  at the beginning of apnea

• Mean difference in arterial pressure of oxygen

  at the end of apnea time

Other Outcomes (2)

• Age

  1 hour preoperatively

• Weight

  1 hour preoperatively

Study Arms (3)

Low group

ACTIVE COMPARATOR

Low flow 100% O2 AT 2 L/min

Device: nasal cannula

Moderate group

ACTIVE COMPARATOR

Low flow 100% O2 AT 4 L/min

Device: nasal cannula

High group

ACTIVE COMPARATOR

Low flow 100% O2 AT 8 L/min

Device: nasal cannula

Interventions

nasal cannula DEVICE

After induction, bag-mask ventilation with 100% oxygen and flow rates of 6 L/ min will be carried out until the expired oxygen concentration will be \>90%, saturation of oxygen was 100%, and end tidal carbon dioxide was 30-40 mmHg. Once this will be reached, bag-mask ventilation will be stopped and apneic oxygenation will be initiated for 3 minutes

Also known as: oxygen nasal cannula

High group; Low group; Moderate group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 to 6 years old weighting 10-20 kg.
• American Society of Anesthesiologists (ASA) physical status I or II.
• Children will be scheduled for elective surgery under general anesthesia.

You may not qualify if:

• Parent refusal
• Patient required nasal intubation
• Children with a cardio-respiratory disease like asthma or recent upper respiratory infection.
• Anemia.
• Obstructive sleep apnea, sepsis.
• Children prone to hypoxia or hypercarbia, and upper airway obstruction.
• Children reported to have nasal obstruction .

Sponsors & Collaborators

• Yasser S Mostafa, MD: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

RECRUITING

Related Publications (3)

• Li S, Hsieh TC, Rehder KJ, Nett S, Kamat P, Napolitano N, Turner DA, Adu-Darko M, Jarvis JD, Krawiec C, Derbyshire AT, Meyer K, Giuliano JS Jr, Tala J, Tarquinio K, Ruppe MD, Sanders RC Jr, Pinto M, Howell JD, Parker MM, Nuthall G, Shepherd M, Emeriaud G, Nagai Y, Saito O, Lee JH, Simon DW, Orioles A, Walson K, Vanderford P, Shenoi A, Lee A, Bird GL, Miksa M, Graciano AL, Bain J, Skippen PW, Polikoff LA, Nadkarni V, Nishisaki A; for National Emergency Airway Registry for Children (NEAR4KIDS) and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Frequency of Desaturation and Association With Hemodynamic Adverse Events During Tracheal Intubations in PICUs. Pediatr Crit Care Med. 2018 Jan;19(1):e41-e50. doi: 10.1097/PCC.0000000000001384.

  PMID: 29210925 BACKGROUND

• Parker MM, Nuthall G, Brown C 3rd, Biagas K, Napolitano N, Polikoff LA, Simon D, Miksa M, Gradidge E, Lee JH, Krishna AS, Tellez D, Bird GL, Rehder KJ, Turner DA, Adu-Darko M, Nett ST, Derbyshire AT, Meyer K, Giuliano J Jr, Owen EB, Sullivan JE, Tarquinio K, Kamat P, Sanders RC Jr, Pinto M, Bysani GK, Emeriaud G, Nagai Y, McCarthy MA, Walson KH, Vanderford P, Lee A, Bain J, Skippen P, Breuer R, Tallent S, Nadkarni V, Nishisaki A; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Relationship Between Adverse Tracheal Intubation Associated Events and PICU Outcomes. Pediatr Crit Care Med. 2017 Apr;18(4):310-318. doi: 10.1097/PCC.0000000000001074.

  PMID: 28198754 BACKGROUND

• Dias R, Dave N, Chhabria R, Shah H, Garasia M. A randomised comparative study of Miller laryngoscope blade versus Oxiport(R) Miller laryngoscope blade for neonatal and infant intubations. Indian J Anaesth. 2017 May;61(5):404-409. doi: 10.4103/ija.IJA_86_17.

  PMID: 28584350 BACKGROUND

MeSH Terms

Conditions

Apnea

Interventions

Cannula

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Safaa G Ragab, MD

  Fayoum University

  STUDY DIRECTOR

• Ahmed A Lotfy, MD

  Fayoum University

  STUDY DIRECTOR

Central Study Contacts

Maha A Mohamed, M.Sc

CONTACT

01061853735; mam56@fayoum.edu.eg

Joseph M Botros, MD

CONTACT

01227598825; jmb00@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the clinically obvious oxygen administration modalities, study personnel in theatres cannot be blinded, but patients and parents will be blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)