Pediatric Patients Clinical Trial
Official title:
Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery; A Prospective Randomized Controlled Study.
The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 8 Years |
Eligibility | Inclusion Criteria: - Age from 3 to 8 years. - Both sexes. - American Society of Anesthesiologists (ASA) physical status I-II. - Children scheduled for elective laparoscopic abdominal surgeries. Exclusion Criteria: - Parental refusal. - Bronchial asthma or any preexisting chest disease. - Congenital deformity of the thoracic cage. - Patients with a history of thoracic surgery. - Cardiac, hepatic, or renal failure. - Obese children with BMI at or above 95th percentile of the same age and sex. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | El-Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative oxygenation | Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen P/F ratio will be assessed before induction of anesthesia, one hour after pneumoperitoneum, and after second recruitment Maneuvere (RM) | One hour after second recruitment Maneuvere | |
Secondary | Lung ultrasound scores | Lung ultrasound scores to assess anesthesia-induced atelectasis and will be performed immediately after intubation, one hour after pneumoperitoneum, one hour after extubation, and 24 hours after extubation | 24 hours after extubation | |
Secondary | Mean arterial blood pressure (MAP) | Mean arterial blood pressure (MAP) will be assessed before induction of anesthesia, immediately after intubation, after first recruitment Maneuvere (RM), one hour after pneumoperitoneum, after second recruitment Maneuvere (RM), and one hour after extubation. | One hour after extubation | |
Secondary | Heart rate | Heart rate (HR) will be assessed before induction of anesthesia, immediately after intubation, after first recruitment Maneuvere (RM), one hour after pneumoperitoneum, after second recruitment Maneuvere (RM), and one hour after extubation. | One hour after extubation | |
Secondary | Postoperative pulmonary complication | Early postoperative pulmonary complication in the first 24 hours postoperative. | 24 hours postoperative |
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