Comparing two breathing methods to improve lung health in children having keyhole surgery

Evaluation of Spirometry-Measured Tidal volume with Low Tidal volume on Lung Function in Pediatric Patients Undergoing Laparoscopic Surgery: A Randomized Controlled double blinded Trial at AIIMS Nagpur - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101641

Enrollment

176

Registered

2026-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: Z759- Unspecified problem related to medical facilities and other health care

Interventions

Intervention1: Spirometry-Measured Tidal Volume: Patients on Mechanical Ventilation will be Ventilated with Tidal Volume obtained by Pre-operative Spirometer for the duration of surgery at least for m

Eligibility

Inclusion criteria

Inclusion criteria: a) Patients aged between 6 years and 12 years of age b) ASA 1 and 2 patients coming for laparoscopic surgery lasting at least 2 hours

Exclusion criteria

Exclusion criteria: 1)Patients who cannot perform spirometry 2)Emergency surgeries 3)ASA grade equal to or greater than 3 4)Paediatric bariatric surgery 5)Previous lung surgery (any) 6)Need for post-op mechanical ventilation Persistent hemodynamic instability History of chronic or acute lung disease Patients with any neuromuscular disease.

Design outcomes

Primary

Measure	Time frame
To evaluate the influence of preoperative spirometry-measured Vt compared with low Vt mechanical ventilation on intra-operative lung atelectasis using ultrasound, and forced expiratory volume in 1 second (FEV1) and forced vital capacity in post operative lung among patients undergoing Laparoscopic surgeryTimepoint: a) Preoperative and postoperatively at 1,6 and 24 hours after extubation FEV1 and FVC by spirometry b) when the patient entered the operating room (time point 1, T1), 5 min after pneumoperitoneum (time point 2 T2), at the end of surgery (time point 3, T3), 1 hour after arrival in the PACU (time point 4, T4). USG lungs for atelectasis in the posterior lung region bilaterally.	—

Measure

Time frame

To evaluate the influence of preoperative spirometry-measured Vt compared with low Vt mechanical ventilation on intra-operative lung atelectasis using ultrasound, and forced expiratory volume in 1 second (FEV1) and forced vital capacity in post operative lung among patients undergoing Laparoscopic surgeryTimepoint: a) Preoperative and postoperatively at 1,6 and 24 hours after extubation FEV1 and FVC by spirometry b) when the patient entered the operating room (time point 1, T1), 5 min after pneumoperitoneum (time point 2 T2), at the end of surgery (time point 3, T3), 1 hour after arrival in the PACU (time point 4, T4). USG lungs for atelectasis in the posterior lung region bilaterally.

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDEEPAK MODI

All India Institute of Medical Sciences Nagpur

deepakmodi354@gmail.com9964592611

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026