NCT02502279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

July 11, 2015

Last Update Submit

March 25, 2017

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • (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    arterial blood gas will be withdrawn 1 hour after extubation and the alveolar minus arterial oxygen difference will be calculated for assessment of oxygenation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 Outcomes (7)

  • PaO2

    intra-operative and 1hour postoperative

  • PaCO2

    intra-operative and 1hour postoperative

  • PH

    intra-operative and 1hour postoperative

  • Respiratory mechanics

    Intraoperative

  • non invasive mean arterial pressure

    intraoperative and 1hour postoperative

  • +2 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

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

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

Lung Recruitment- PEEP and CPAP group

ACTIVE COMPARATOR

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

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

Interventions

Engström Datex-Ohmeda ICU VentilatorDEVICE

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.

Lung Recruitment- PEEP and CPAP groupLung Recruitment- PEEP group
Postoperative CPAP maskDEVICE

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.

Lung Recruitment- PEEP and CPAP group

Eligibility Criteria

Age6 Months - 6 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients undergoing laparoscopic surgery for abdominal cryptorchidism.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

Location

Study Officials

  • Hala S Abdel-Ghaffar, MD

    Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 11, 2015

First Posted

July 20, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)