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Lung Recruitment and Postoperative CPAP (LRvsCPAP)

A

Assiut University

Status and phase

Completed
Phase 2

Conditions

Anesthesia

Treatments

Device: Postoperative CPAP mask
Device: Engström Datex-Ohmeda ICU Ventilator

Study type

Interventional

Funder types

Other

Identifiers

NCT02502279
IRB00008718/ refer.34

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 patients

Sex

Male

Ages

6 months to 6 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

Control
No Intervention group
Description:
Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters with 0 PEEP/CPAP.
Lung Recruitment- PEEP group
Active Comparator group
Description:
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.
Treatment:
Device: Engström Datex-Ohmeda ICU Ventilator
Lung Recruitment- PEEP and CPAP group
Active Comparator group
Description:
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
Treatment:
Device: Postoperative CPAP mask
Device: Engström Datex-Ohmeda ICU Ventilator

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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