Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy

NCT ID: NCT01629186

Last Updated: 2012-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-12-31

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.

Conditions

Bradycardia; Hypoxemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

outcome

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.

Group Type: EXPERIMENTAL

NPO with Nose-close and Abdomen-compression

Intervention Type: 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.

Interventions

NPO with Nose-close and Abdomen-compression

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.

Intervention Type: OTHER

Other Intervention Names

(1)Nasopharygeal oxygen; (2)Nose-close and Abdomen-compression

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• cannot nasal approach flexible bronchoscopy.

• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cho-yu Chan, MD

OTHER_GOV

Sponsor Role: lead

Responsible Party

Cho-yu Chan, MD

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wen-Jue Soong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics; Taipei-Veteran General Hospital

Locations

Taipei-Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: RESULT

PMID: 21513991 (View on PubMed)

Other Identifiers

NPO-NC-AC in Ped. FB

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VGH-94-269C

Identifier Type: -

Identifier Source: org_study_id