The comparison of positive pressure delivered at the end of expiration administered by a supra glottic airway device with no positive pressure delivered on severity of lung collapse during/after surgery under anaesthesia

The effect of positive end-expiratory pressure administered by Proseal laryngeal mask airway on peri-operative atelectasis - A randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056277

Enrollment

Registered

2023-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Positive end expiratory pessure(PEEP): A PEEP of 8cm H20 will be applied in patients of Group P. PEEP will be applied after insertion of Proseal LMA till the patient is awake after gene

Eligibility

Inclusion criteria

Inclusion criteria: Patients 18-65 years of age Both male, female ASA I and II Posted for elective lower abdominal and urological surgery will be included

Exclusion criteria

Exclusion criteria: Patients less than 18years and more than 65 years of age ASA III and IV Patients with any lung disease Patients with cardiac disease Obesity BMI >30 Kg/m2 Pregnancy Anaemia Hb Anticipated difficult airway Patients posted for laproscopic upper abdominal surgeries will be excluded

Design outcomes

Primary

Measure	Time frame
To compare the loss of lung aeration (atelectasis) as measured by modified lung ultrasound score between the PEEP (8cm H2O) and No PEEP group.Timepoint: A: Baseline, before induction of anesthesia B: 10 minutes following induction of general anesthesia C: 1 hour following induction of general anesthesias D: 30 minutes after removal of PLMA	—

Secondary

Measure	Time frame
1.Gas leakage around the Proseal LMA(PLMA) 2.Peak inspiratory pressure (PIP) and dynamic compliance 3.PaO2/FiO2 ratio 4.Displacement or malpositioning of the PLMATimepoint: 1. Gas leakage will be determined built-in leakage detection system of ventilator and presence of audible gas leakage at 5min,30min and 60min after insertion of PLMA 2. The PIP and dynamic compliance (C-dy) will be noted from the ventilator at 5min and 30min after device insertion. 3. PaO2/FiO2(P/F) ratio will be noted at baseline, 1 hour following induction of general anesthesia and 30min postoperatively by obtaining arterial blood samples.	—

Measure

Time frame

1.Gas leakage around the Proseal LMA(PLMA) 2.Peak inspiratory pressure (PIP) and dynamic compliance 3.PaO2/FiO2 ratio 4.Displacement or malpositioning of the PLMATimepoint: 1. Gas leakage will be determined built-in leakage detection system of ventilator and presence of audible gas leakage at 5min,30min and 60min after insertion of PLMA 2. The PIP and dynamic compliance (C-dy) will be noted from the ventilator at 5min and 30min after device insertion. 3. PaO2/FiO2(P/F) ratio will be noted at baseline, 1 hour following induction of general anesthesia and 30min postoperatively by obtaining arterial blood samples.

—

Countries

India

Contacts

Public ContactDr Neha Pangasa

AIIMS, New Delhi

nehapangasa@gmail.com9810383313

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026