Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning

• Sponsor: Hospital Pablo Tobón Uribe (Other)
• Overall Status: Completed
• CT.gov ID: NCT01069185
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 15.5

Study Details

Study Description

Brief Summary

Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.

Condition or Disease	Intervention/Treatment	Phase
Hypoxemia; Arrhythmias; Cardiac Arrest; Ventilator Associated Pneumonia	Procedure: Necessity endotracheal suctioning; Procedure: Routine endotracheal suctioning	N/A

Detailed Description

Endotracheal aspiration is a very useful procedure. It has several adverse events every time that aspiration is practiced. This trials wants to identify which protocol (necessity versus routine) could be better to practice in pediatrics intensive care unit with less risk.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Differences in Morbidity Frequency Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning Protocol in Hospital Pablo Tobon Uribe´s Pediatric Intensive Care Unit (PICU). A Randomized Controlled Trial
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Necessity endotracheal suctioning Endotracheal suctioning depends on clinical manifestations	Procedure: Necessity endotracheal suctioning; Endotracheal suctioning depends on clinical manifestations
Other: Routine endotracheal suctioning Endotracheal suctioning every two hours	Procedure: Routine endotracheal suctioning; Endotracheal suctioning every two hours

Outcome Measures

Primary Outcome Measures

1. Primary Composite End Point [Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .]

   All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.

Secondary Outcome Measures

1. Mechanical Ventilation Length as Days. [Every day while patient really is intubated.]

   Number of days under mechanical ventilation during ICU hospitalization length

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children older than 1 month until 14 years old requiring orotracheal intubation

Exclusion Criteria:

• High frequency ventilation mode

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Pablo Tobon Uribe	Medellin	Antioquia	Colombia

Sponsors and Collaborators

• Hospital Pablo Tobón Uribe

Investigators

• Principal Investigator: Gloria L Lema, MD, Hospital Pablo Tobon Uribe

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gloria Lema, MD, Hospital Pablo Tobón Uribe
• ClinicalTrials.gov Identifier: NCT01069185
• Other Study ID Numbers: 5100-66779
• First Posted: Feb 17, 2010
• Last Update Posted: Sep 11, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Gloria Lema, MD, Hospital Pablo Tobón Uribe: Unplanned extubation; Length of stay in PICU; Length of mechanical ventilation
• Additional relevant MeSH terms: Pneumonia, Ventilator-Associated; Hypoxia

Study Results

Participant Flow

Arm/Group Title	Necessity Endotracheal Suctioning	Routine Endotracheal Suctioning
Arm/Group Description	Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations	Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours
Period Title: Overall Study
STARTED	47	45
COMPLETED	47	45
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Necessity Endotracheal Suctioning	Routine Endotracheal Suctioning	Total
Arm/Group Description	Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations	Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours	Total of all reporting groups
Overall Participants	47	45	92
Overall suctioning number	606	649	1255
Age (months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [months]	34	56	40.5
Sex: Female, Male (Count of Participants)
Female	21 44.7%	23 51.1%	44 47.8%
Male	26 55.3%	22 48.9%	48 52.2%
Weight (Kgs) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Kgs]	15	15	15
PRISM (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	23	23	23

Outcome Measures

1. Primary Outcome

Title	Primary Composite End Point
Description	All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.
Time Frame	Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Necessity Endotracheal Suctioning	Routine Endotracheal Suctioning
Arm/Group Description	Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations	Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours
Measure Participants	47	45
Measure suctioning	606	649
Number [event]	35	48

2. Secondary Outcome

Title	Mechanical Ventilation Length as Days.
Description	Number of days under mechanical ventilation during ICU hospitalization length
Time Frame	Every day while patient really is intubated.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Necessity Endotracheal Suctioning	Routine Endotracheal Suctioning
Arm/Group Description	Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations	Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours
Measure Participants	47	45
Median (Inter-Quartile Range) [Days]	2.5	2.4

Adverse Events

Arm/Group Title	Necessity Endotracheal Suctioning		Routine Endotracheal Suctioning
Arm/Group Description	Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations		Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours
All Cause Mortality
	Necessity Endotracheal Suctioning		Routine Endotracheal Suctioning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/47 (19.1%)		12/45 (26.7%)
Serious Adverse Events
	Necessity Endotracheal Suctioning		Routine Endotracheal Suctioning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		1/45 (2.2%)
Respiratory, thoracic and mediastinal disorders
VAP	0/47 (0%)	0	1/45 (2.2%)	1
Other (Not Including Serious) Adverse Events
	Necessity Endotracheal Suctioning		Routine Endotracheal Suctioning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/47 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.