Lung Recruitment and Postoperative CPAP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

Brief Summary

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General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation.

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Detailed Description

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General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation. However, the effect of recruitment manoeuvre is short lasting and does not extend to the post operative period. Postoperative CPAP keeps the lung open and can improve oxygenation in the early postoperative period.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control

Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters with 0 PEEP/CPAP.

Group Type NO_INTERVENTION

No interventions assigned to this group

Lung Recruitment- PEEP group

Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters plus lung recruitment manoeuvre with peak inflation pressure 35 cmH2O for 15 seconds followed by PEEP until extubation delivered by the ventilator.

Group Type ACTIVE_COMPARATOR

Engström Datex-Ohmeda ICU Ventilator

Intervention Type DEVICE

patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation.

Lung Recruitment- PEEP and CPAP group

Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters plus

1. lung recruitment manoeuvre with peak inflation pressure 35 cmH2O for 15 seconds followed by PEEP until extubation delivered by the ventilator.
2. Postoperative CPAP mask immediately after extubation

Group Type ACTIVE_COMPARATOR

Engström Datex-Ohmeda ICU Ventilator

Intervention Type DEVICE

patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation.

Postoperative CPAP mask

Intervention Type DEVICE

patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation and a CPAP mask will be applied immediately postoperative.

Interventions

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Engström Datex-Ohmeda ICU Ventilator

patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation.

Intervention Type DEVICE

Postoperative CPAP mask

patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation and a CPAP mask will be applied immediately postoperative.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients undergoing laparoscopic surgery for abdominal cryptorchidism.

Exclusion Criteria

* Cardio-respiratory illness.
* Unsatisfactory preoperative peripheral arterial oxygen saturation.
* Unsatisfactory preoperative hemoglobin level.
* Neurological or psychiatric disease.
* Children with a BMI \>95th percentile for age.

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No