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NCT Number: NCT06659887

Different Low Flow Rates on Gas Exchange in Children During Apnea

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

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Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location status: Recruiting

Location contact

Ahmed A Lotfy, MD

SUB_INVESTIGATOR

Joseph M Botros, MD

SUB_INVESTIGATOR

Safaa G Ragab, MD

PRINCIPAL_INVESTIGATOR

Yasser S Mostafa, MD.

CONTACT

[email protected]

01010509735 ext. +20

About this study

Introduction: During induction of general anesthesia using muscle relaxant, all patients experience a period of apnea which begins when mask ventilation is stopped prior to laryngoscopy and tracheal intubation and ends when ventilation is resumed. This period is a critical time as pediatrics especially infants and younger children are more liable for hypoxia than older children and adolescents. Hypoxia during this period of time in turn, had been proved to increase morbidity and mortality. Apneic oxygenation means uptake of oxygen by the blood from the lungs in the absence of spontaneous respiration or positive pressure ventilation, and its effectiveness in reducing the risk of hypoxemia during intubation in children had been proved. Many variables and outcomes had been studied during low flow apneic oxygenation in pediatrics and it was found that, it doesn't not only reduce the risk of hypoxemia but also prolongs of the safe apnea time up to 6 mins even when compared with high flow apneic oxygenation.

Anesthetic technique:

All children will undergo routine preoperative investigations: Complete blood count and coagulation profile. First, they will be examined as regards the fulfillment of inclusion criteria to be in the study or to be excluded from the study. Then, All children will receive premedication using midazolam 0.5 mg/kg intramuscular and intramuscular atropine 0.02 mg /kg.

Before induction of anaesthesia, patient characteristics and vital signs will be recorded {pulse oximetry, ECG, non-invasive blood pressure, end-tidal carbon dioxide}and will be applied all over the operation.

While establishing of IV access, all children will be preoxygenated using 6 liter/min of 100% O2 for 3 mins and if there will be a difficulty in obtaining an IV access, patients will be induced with inhaled sevoflurane followed by the placement of an IV cannula. Then, 2-3mg/Kg of Propofol, 1mcg/Kg of Fentanyl, and 0.3-0.5 mg/kg of Atracurium will be given. During induction of anesthesia an expert pediatric anesthesiologist will introduce an arterial radial cannula.

Intubation with an appropriate endotracheal will be started. After intubation a standardized manual airway recruitment maneuver will be performed. Mechanical ventilation will be started using pressure controlled-volume grantee mode and tidal volume will be adjusted to be 6 mg/kg/min and general anesthesia will be maintained using Isoflurane 1% minimum alveolar concentration. The lowest oxygen saturation and highest end-tidal carbon dioxide during the first five breaths will be recorded.

After recovery of all patients and before leaving the post anesthesia care unit(PACU), all parents will be asked about any postoperative side effects such as postoperative nausea and vomiting, stridor, coughing, laryngospasm, bronchospasm or pain.

Statistical analysis:

There is no published literature that covered the research idea to be used for sample sized calculation. So, we will conduct a pilot study of at least 5 patients in each group and use the obtained parameters for sample size calculation Statistical analysis will be performed using Statistical Package for the Social Sciences (SPSS) for Windows, version 29(IBM Corp., New York,USA). Descriptive statistics will be presented in the form of (mean ± SD), or (median and interquartile range) for numerical data, while numbers and percentages will be used for categorical data.

Testing for normality of distribution will be done using the Shapiro-Wilk test. Categorical variables will be analyzed using Chi-square test or Fisher's exact test. Differences in parametric normally distributed data will be compared using Student's t-tests, while the non-parametric data will be compared using Mann-Whitney U-test. Results will be considered statistically significant if P value is less than 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 .

Treatment and study plan

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

Other names: oxygen nasal cannula

Primary outcomes

  1. rise of arterial pressure of carbon dioxide

    Time frame: between 60s and 180s time points of apnea

    mmHg

Secondary outcomes

  1. Time to oxygen desaturation

    Time frame: 5 seconds after the onset of apnea

    below 95%

  2. Number of patients reached 6 minutes of apnea

    Time frame: 1 minute after end of apneic oxygenation

    Count number of patients in each group

  3. Pressure difference between the end-tidal carbon dioxide and the arterial carbon dioxide

    Time frame: Between the end of apnea and the preceding blood gas

    mmHg

  4. Mean difference in arterial pressure of oxygen

    Time frame: at the beginning of apnea

    mmHg

  5. Mean difference in arterial pressure of oxygen

    Time frame: at the end of apnea time

    mmHg

  6. Lowest recorded oxygen saturation

    Time frame: throughout the apneic oxygenation

    in percentage (%)

  7. Heart rate

    Time frame: Before anaesthetizing child

    beat/minute

  8. Mean arterial blood pressure

    Time frame: Before anaesthetizing child

    mmHg

  9. Heart rate

    Time frame: During apnea time

    beat/minute

  10. Mean arterial blood pressure

    Time frame: During apnea time

    mmHg

  11. Occurence of sore throat

    Time frame: in first postoperative day

    Yes or no

Other outcomes

  1. Age

    Time frame: 1 hour preoperatively

    Years

  2. Weight

    Time frame: 1 hour preoperatively

    Kilogram

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph M Botros, MD

CONTACT

[email protected]

01227598825 ext. +2

Maha A Mohamed, M.Sc

CONTACT

[email protected]

01061853735 ext. +2

Sponsors and collaborators

Lead sponsor

Yasser S Mostafa, MD

Other

Registry information

Official study title

Effect of Different Low Flow Rates on Gas Exchange in Anesthetized Children During Apnea A Single Blinded Randomized Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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