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A clinical trial to study the effect of different ventilator settings on lung health after surgery in undernourished kids: A Research Study

Effect of predicted versus actual body weight based tidal volume setting on postoperative atelectasis in malnourished children undergoing surgery under general anaesthesia: A Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061519
Enrollment
84
Registered
2024-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q50-Q56- Congenital malformations of genital organs Health Condition 2: Q60-Q64- Congenital malformations of the urinary system Health Condition 3: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities Health Condition 4: K00-K95- Diseases of the digestive system Health Condition 5: N00-N99- Diseases of the genitourinary system Health Condition 6: M00-M99- Diseases of the musculoskeletal system and connective tissue Health Condition 7: K40-K46- Hernia

Interventions

Intervention1: Delivering tidal volume based on predicted body weight as per height in malnourished children: After induction, patient will be ventilated with volume control ventilation (VCV) with tid

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Parental willingness to give consent for inclusion in study. 2)Malnourished children with measured body weight 5 to 8 years. 3)Children aged 1-8 years. 4)Children with physical status ASA grade 1-3 5)Children undergoing elective surgery of duration more than 30 minutes in supine position.

Exclusion criteria

Exclusion criteria: 1)Parental refusal to participate in the study. 2)Children with known severe lung disease, history of severe lung infection having post infection sequelae in preoperative chest x-ray. 3)Children with known deformity of chest wall or thoracic spine. 4)Children undergoing surgery in any position other than supine and lithotomy position. 5)Children undergoing laparoscopic surgery. 6)Children with pre-existing significant cardiac, renal, or hepatic diseases. 7)Children with history of previous thoracic surgery. 8)Children with BMI > 30 kg/m2

Design outcomes

Primary

MeasureTime frame
Difference in lung aeration score between both groups in PACU one hour after extubation. Lung aeration will be assessed by lung ultrasound score.Timepoint: one hour after extubation in PACU

Secondary

MeasureTime frame
1)Incidence of positive air test 2)SpO2/ FiO2 (S/F) ratio 3)Oxygen Saturation Index (OSI) 4)Duration of oxygen supplementation between both groups to maintain oxygen saturation of â?¥ 97% in PACU. 5)Number of patients requiring oxygen supplementation in ward 6)Age group specific time weighted average of Peak airway pressure (PIP), Plateau pressure (Pplat) and Driving pressure (DP) between both groups during the intraoperative period. 7)Age group specific time weighted average of mechanical power between both groups during the intraoperative period. 8)Age group specific respiratory rate between both groups.Timepoint: 1)5 minutes after induction and the end of surgery before extubation and in PACU one hour after extubation 2)5 minutes after induction and at the end of surgery before extubation. 3)5 minutes after induction and at the end of surgery before extubation. 4)in PACU 5)in first 3 postoperative days in ward 6)after confirmation of proper positioning of ET tube and then at a five minutes interval till extubation 7) Intraoperative period 8)Intraoperative period

Countries

India

Contacts

Public ContactAyushi

AIIMS New Delhi

drrakesh.kumar.akb@gmail.com7838043581

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026