Lung Recruitment and Postoperative CPAP

Phase 2

Completed

• Conditions: Anesthesia
• Interventions: Device: Engström Datex-Ohmeda ICU Ventilator; Device: Postoperative CPAP mask

• Registration Number: NCT02502279
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-11
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-25
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung Recruitment- PEEP and CPAP group	Engström Datex-Ohmeda ICU Ventilator	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
Lung Recruitment- PEEP group	Engström Datex-Ohmeda ICU Ventilator	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.
Lung Recruitment- PEEP and CPAP group	Postoperative CPAP mask	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

Primary Outcome Measures

Name	Time	Method
(A-a) DO2	1 hour after extubation	arterial blood gas will be withdrawn 1 hour after extubation and the alveolar minus arterial oxygen difference will be calculated for assessment of oxygenation

Secondary Outcome Measures

Name	Time	Method
PaCO2	intra-operative and 1hour postoperative	arterial blood gas samples will be withdrawn to assess PaCO2.
PaO2	intra-operative and 1hour postoperative	arterial blood gas samples will be withdrawn to assess Pa O2.
PH	intra-operative and 1hour postoperative	arterial blood gas samples will be withdrawn to assess PH.
Respiratory mechanics	Intraoperative	intra-operative ventilator data will be recorded to measure respiratory mechanics such as dynamic and statistic compliance
non invasive mean arterial pressure	intraoperative and 1hour postoperative	non invasive mean arterial pressure will be recorded before and after recruitment manouvre, after pneumoperitonium and after pneumoperitonium deflation
Heart rate	intraoperative and 1hour postoperative	the heart rate will be recorded before and after recruitment manoeuvre, after pneumoperitonium, and after pneumoperitonium deflation and early postoperative..
Peripheral arterial oxygenation SPO2%	intraoperative and 1hour postoperative	The SPO2% will be recorded before and after recruitment manouvre, after peumoperitoneum inflation and after pneumoperitoneum deflation and early postoperative

Trial Locations

Locations (1)

Pediatric hospital; 🇪🇬 Assiut, Assiut governorate, Egypt