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Completed

NCT Number: NCT02502279

Lung Recruitment and Postoperative CPAP

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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Key information

Conditions

Anesthesia

Age range

6 month–6 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Engström Datex-Ohmeda ICU Ventilator

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

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.

Primary outcomes

  1. (A-a) DO2

    Time frame: 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    arterial blood gas will be withdrawn 1 hour after extubation and the alveolar minus arterial oxygen difference will be calculated for assessment of oxygenation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 outcomes

  1. PaO2

    Time frame: intra-operative and 1hour postoperative

    arterial blood gas samples will be withdrawn to assess Pa O2.

  2. PaCO2

    Time frame: intra-operative and 1hour postoperative

    arterial blood gas samples will be withdrawn to assess PaCO2.

  3. PH

    Time frame: intra-operative and 1hour postoperative

    arterial blood gas samples will be withdrawn to assess PH.

  4. Respiratory mechanics

    Time frame: Intraoperative

    intra-operative ventilator data will be recorded to measure respiratory mechanics such as dynamic and statistic compliance

  5. non invasive mean arterial pressure

    Time frame: intraoperative and 1hour postoperative

    non invasive mean arterial pressure will be recorded before and after recruitment manouvre, after pneumoperitonium and after pneumoperitonium deflation

  6. Heart rate

    Time frame: intraoperative and 1hour postoperative

    the heart rate will be recorded before and after recruitment manoeuvre, after pneumoperitonium, and after pneumoperitonium deflation and early postoperative..

  7. Peripheral arterial oxygenation SPO2%

    Time frame: intraoperative and 1hour postoperative

    The SPO2% will be recorded before and after recruitment manouvre, after peumoperitoneum inflation and after pneumoperitoneum deflation and early postoperative

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Lung Recruitment and Postoperative CPAP in Pediatric Laparoscopic Surgery

Acronym: LRvsCPAP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2015
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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