Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy

NCT01629186 | Completed DMC

• 2 other identifiers: VGH-94-269CNPO-NC-AC in Ped. FB
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Bradycardia; Hypoxemia

Keywords

CPR; flexible bronchoscope; resuscitation; ventilation

Outcome Measures

Primary Outcomes (1)

• Heart rate (beat/min)

  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.

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

Secondary Outcomes (2)

• 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.

Study Arms (1)

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.

Other: NPO with Nose-close and Abdomen-compression

Interventions

NPO with Nose-close and Abdomen-compression OTHER

Infants with body weight (BW) \<5.0 kg and receiving nasal diagnostic or interventional FB 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.

Also known as: (1)Nasopharygeal oxygen, (2)Nose-close and Abdomen-compression

outcome

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• cannot nasal approach flexible bronchoscopy.

Sponsors & Collaborators

• Cho-yu Chan, MD: lead

Study Sites (1)

Taipei-Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (1)

• Soong WJ, Shiao AS, Jeng MJ, Lee YS, Tsao PC, Yang CF, Soong YH. Comparison between rigid and flexible laser supraglottoplasty in the treatment of severe laryngomalacia in infants. Int J Pediatr Otorhinolaryngol. 2011 Jun;75(6):824-9. doi: 10.1016/j.ijporl.2011.03.016. Epub 2011 Apr 21.

  PMID: 21513991 RESULT

MeSH Terms

Conditions

Bradycardia; Hypoxia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Wen-Jue Soong, MD

  Department of Pediatrics; Taipei-Veteran General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Taipei Veterans General Hospital,Taiwan, Taipei Veterans General Hospital,Taiwan

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: June 27, 2012
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: June 27, 2012

Record last verified: 2012-06

Locations

TW (1)