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Clinical Trials/NCT01629186
NCT01629186CompletedNot Applicable

Nasopharyngeal Oxygen With Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy

Cho-yu Chan, MD1 site in 1 country156 target enrollmentStarted: January 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
156
Locations
1
Primary Endpoint
Heart rate (beat/min)

Study Overview

Brief Summary

The nasopharyngeal oxygen (NPO) with Nose-close (NC) and Abdomen-compression (AC) technique may use for support or rescue asphyxiated infants during Flexible bronchoscopy.

Detailed Description

OBJECTIVES: To evaluate the efficacy of a novel cardiopulmonary resuscitation (CPR) technique-nasopharyngeal oxygenation with nose-close and abdomen-compression (NPO-NC-AC)-in small infants during flexible bronchoscopy (FB).

METHODS: Infants with body weight (BW) <5.0 kg and receiving nasal diagnostic or interventional FB (dFB, iFB) were enrolled. Under NPO (0.5 L/kg/min), when infant's heart rate (HR) <80 beats/min or oxygen saturation (SpO2) <85% for more than 10 seconds, rescue NC-AC was initiated. It was performed by (1) increased NPO flow to 0.5-1.0 L/kg/min; (2) NC 1 second for inspiration; and (3) AC 1 second for expiration with simultaneously released nostrils. Repeat doing steps (2) and (3) at a rate of 30 cycles/min until HR, SpO2, and blood pressure (BP) returned to normal. Cardiopulmonary parameters were monitored and analyzed.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
— to 20 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •body weight (BW) less than 5.0 kg;
  • •receiving nasal approach flexible bronchoscopy.

Exclusion Criteria

  • •cannot nasal approach flexible bronchoscopy.

Arms & Interventions

outcome

Experimental

Cardiopulmonary parameters were measured and recorded at baseline, just before and at every minute during NC-AC, and at the end of the FB session. In infants who already had an arterial line, arterial blood gas (ABG) analyses were taken for study. Data was represented as mean ± SD. The results obtained from the baseline and different stages. The values were considered statistically significant only when p < 0.05.

Technique failure was defined as: any vital signs of hypoxia did not return to accepted levels(HR>100 beat/min, SpO2>90%, mean BP>50 mmHg)within 2 minutes of the experimental CPR technique. Then traditional CPR procedures involving bag-mask ventilation, endotracheal intubation, Ambu bag ventilation or even chest compressions were substituted.

Intervention: NPO with Nose-close and Abdomen-compression (Other)

Outcomes

Primary Outcomes

Heart rate (beat/min)

Time Frame: Participants will continually monitoring by EKG for 2 days after the procedure.

During and after this FB procedure, vital signs are continually monitoring. When the heart rate (HR) \<80 beat/min (measured by continuouse wave and digit form of EKG monitor) and lasting \>10 seconds. Immediately rescued with rhythmic NC-AC. If the heart rate did not reach to its acceptable level (\>80 beat/min) within 2 minutes, then traditional CPR procedures involving bag-mask ventilation, ET intubation, Ambu bag ventilation or even chest compressions were substituted.

Secondary Outcomes

  • Oxygen saturation by pulse oximetry(Participants will continually monitoring by pulse oximeter for 2 days after the procedure.)
  • Mean blood pressure (mmHg)(Participants will continually monitoring by sphygmomanometer for 2 days after the procedure.)

Investigators

Sponsor
Cho-yu Chan, MD
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Cho-yu Chan, MD

Taipei Veterans General Hospital,Taiwan, Taipei Veterans General Hospital,Taiwan

Taipei Veterans General Hospital, Taiwan

Study Sites (1)

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