Lung Recruitment and Postoperative CPAP

Anesthesia Clinical Trial

— LRvsCPAP  

Official title:

Lung Recruitment and Postoperative CPAP in Pediatric Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502279
• Other study ID #: IRB00008718/ refer.34
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2015
• Last updated: March 25, 2017
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Pediatric hospital	Assiut	Assiut governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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	PaO2	arterial blood gas samples will be withdrawn to assess Pa O2.	intra-operative and 1hour postoperative
Secondary	PaCO2	arterial blood gas samples will be withdrawn to assess PaCO2.	intra-operative and 1hour postoperative
Secondary	PH	arterial blood gas samples will be withdrawn to assess PH.	intra-operative and 1hour postoperative
Secondary	Respiratory mechanics	intra-operative ventilator data will be recorded to measure respiratory mechanics such as dynamic and statistic compliance	Intraoperative
Secondary	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
Secondary	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
Secondary	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