Lung Recruitment and Postoperative CPAP (LRvsCPAP)

Lung Recruitment and Postoperative CPAP in Pediatric Laparoscopic Surgery

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Device: Engström Datex-Ohmeda ICU Ventilator; Device: Postoperative CPAP mask

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut governorate
    • Assiut, Assiut governorate, Egypt, 715715
      • Pediatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters with 0 PEEP/CPAP.
Active Comparator: 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.	Device: 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.
Active Comparator: 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; lung recruitment manoeuvre with peak inflation pressure 35 cmH2O for 15 seconds followed by PEEP until extubation delivered by the ventilator.; Postoperative CPAP mask immediately after extubation	Device: 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.; 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.

What is the study measuring?

Primary Outcome Measures

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(A-a) DO2	arterial blood gas will be withdrawn 1 hour after extubation and the alveolar minus arterial oxygen difference will be calculated for assessment of oxygenation	1 hour after extubation

Secondary Outcome Measures

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PaO2	arterial blood gas samples will be withdrawn to assess Pa O2.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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 11, 2015
• First Submitted That Met QC Criteria: July 17, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 25, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IRB00008718/ refer.34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No